Table of Contents
Introduction _____________________________________________
Voltaic Solutions’ Mission Executive Summary: Design & Technology________________________
Technology
Increased Recovery Time with Electric Field
TENS Pain Treatment
Design
Adhesive Electrode Bandage Strips
Microbattery Array and Gauze Section
Removable TENS Unit
Coverage Film
Manufacturing
Intellectual Property Strategy
Device Patentability
Patent Infringement
Licensing
Trademark
Risk Analysis
Risk Management
Failure Modes and Effects Analysis
Risk Mitigation
Executive Summary: Market Analysis and Entry____________________
The Bandage Market
Market Needs
Target Market and Users
Marketing Design: Logo, Packaging, Labelling
Marketing Materials
Market Competition
Market Penetration and Entry
2
Executive Summary: Regulations and Clinical Trial Strategy___________
Device Regulation
Device Classification
General Controls
Special Controls
510(k) Application
Quality System Regulation Requirements
Clinical Strategy
Preclinical Testing and IDEs
Model Feasibility, Safety and Efficacy Testing (In Vitro)
Animal Testing
Human Clinical Trials Strategy
Safety/Biocompatibility Trial Design
Efficacy Trial Design
Patient Eligibility Criteria
Executive Summary: Finances and Reimbursement__________________
Market Size Analysis
Financial Analysis
Assumptions
Financing
Production, Distribution, and Profits
The First Year of Business
Profit Forecast for Three Years
Future
Feasibility
Reimbursement Strategy
Reimbursement Coding
National and Local Coverage
Private Coverage
3
Feasability
References:______________________________________________ Appendices:______________________________________________ Introduction Voltaic Solutions’ Mission
Voltaic Solutions is a burgeoning Los Angelesbased medical startup company
dedicated to improving electroceutical technologies. Electroceutical technologies are
those that employ electrical stimulation, as opposed to drugs, to achieve desired
biological changes in the body. Voltaic Solutions’ mission is to produce novel devices
and treatments in the hopes of increasing quality of life for postoperative patients, the
elderly population, those with chronic afflictions, and everyday Americans. Voltaic
Solutions’ first signature device, BandWave™, is a bandage that targets the wound
healing and pain management sectors of the healthcare industry. BandWave™ uses
tailored electrical stimulation to accelerate wound closure rates and is a drugfree
alternative to other pain management options. Subsequent to the production of the
BandWave™ bandage, Voltaic Solutions will continue pioneering electroceutical
innovation with its sights set on electrical stimulation to relieve symptoms of arthritis,
among other applications.
4
Executive Summary: Design
BandWave™ by Voltaic Solutions is a dualpurpose bandage intended for
epidermal wounds. This innovative device integrates TENS technology and a micro
battery array in order to increase the speed of healing as well as relieve pain. Increasing
the speed of healing and decreasing pain of wounds have different but equally
important purposes. BandWave™ can be used on individuals that have an open
epidermal wound (burns, or broken or inflamed skin) or patients that have recently
received stitches. Currently, in order to relieve pain, patients must either apply analgesic
creams such as Tiger Balm or lidocaine creams or must ingest medication such as Advil
or Vicodin. Neither of the creams can be used on or around open wounds and the pain
relieving pills have undesirable side effects throughout the entire body, such as impaired
cognitive function. Although there are a few products that increase the speed of wound
healing, there is currently nothing on the market with the dual purpose of increasing the
speed of wound healing and reducing pain. BandWave™ fills in the market gap with the
revolutionary design that combines the pain relief from the TENS with the wound
healing of the micro battery array in a variable size bandage that blends into natural
skin tone and can be cut to support the healing of differently shaped wounds in different
areas of the body.
BandWave™ will be sold in bandage strips 16x13 cm in order to properly heal
largesized wounds. BandWave™ has three perforations that it can be cut along in order
to use the bandage on flat surfaces (such as the chest, back, forearm) or on joints (such
as elbow, finger, and knee). The manual that is included with each bandage outlines the
specific cuts that must be made for each type of wound. Since there are ports for a TENS
unit on both sides of the bandage, cutting the bandage along specified perforations
allows the single bandage to become two usable bandages. On either side of the
microbattery array, there are adhesive electrodes that are used to keep the BandWave™
in place on the skin and to connect to the TENS device. The TENS apparatus is
removable and reusable and will have two wires that connect to the electrodes on the
bandage. The TENS apparatus is held in place by these wires and a thin adhesive and
waterproof film that covers the entire system of bandage plus the TENS apparatus itself.
The microbattery array constantly works to increase wound healing speed while the
5
TENS only works when the apparatus is plugged in and turned on, which means that the
patient has control over the pain management system.
In order to ensure that BandWave™ has a potential future in becoming a
successful device, we must examine its patentability. To determine whether or not it is a
patentable device, we analyzed the novelty, nonobviousness, and usefulness of the
device and concluded that it meets each of these individual criteria. After deeming this
invention patentable, existing patents with similar claims to those of BandWave™ were
researched through databases such as the US Patent Collection Database and the
European Patent Office. The patents that were found to be comparable were then closely
studied to determine if this device is at risk of patent infringement. If the threat of
infringement exists, a licensing strategy will be considered in order to mitigate risk. In
addition to patents and licenses, the pursuit of a registered trademark for BandWave™
will be considered for the purpose of providing identification and distinguishability from
the competition.
Throughout the design process of BandWave™, Voltaic Solutions has performed
risk analysis in order to identify and mitigate the hazards associated with usage of the
device. The risk management process is an essential element in device design and acts as
a tool for inventors in the creation of a safe and effective device. The specific failures
unique to each component of BandWave™, their cause, and their effect on the device as
a whole are listed in the Failure Modes and Effects Analysis table. Furthermore, the
recommended steps for mitigation of these risks are listed in the Risk Mitigation table.
6
Technology
Increased Recovery Time with Electric Field
Many recent scientific studies have shown that electrical stimulation of a wounded area
helps speed up recovery time, and these studies propose this as a revolutionary new
technique to aid the healing process. Because human skin naturally absorbs positive
sodium ions and secretes negative chloride ions, the area under the skin is positively
charged. When a cut is made to the skin (laceration), nothing is able to hold back the
electric current, which now flows out of the body in the area of the cut, creating a voltage
gradient. This voltage gradient is in part responsible for causing cells to divide faster
and more easily, facilitating the reparation of damaged tissue [1]. By increasing the
voltage gradient using a voltage/currentproducing bandage, the healing processes can
be artificially sped up.
TENS Pain Treatment
7
TENS has been commonly used as a method for symptomatic relief, management of
long term pain, and treatment for postsurgical traumatic acute pain. This nerve
stimulation works by administering electrical current to help stimulate the nerves to
block pain signals from reaching the brain. The process has been known to be similar to
the results of acupuncture. TENS also stimulates the body to produce higher levels of
endorphins to relieve some of the pain from the wound [2]. The TENS unit in the electric bandage will utilize a similar design as the one shown below. The unit produces
a monophasic pulse of 50 mA at a frequency of 60 Hz and a pulse width of about 90
microseconds.
Design
Photo Realistic Rendered Image
8
9
Exploded View: Full Bandage
10
Layer Number Design Component
1 TENS Units
2 ETS Bandage Fabric
3 Electrode
4 Adhesive Gel (included on electrode)
5 Gauze
6 MicroBattery Array
Top of Bandage
11
Perforations are visible on the image for possible cuts. Wire connections are visible for
the TENS unit. The top of the bandage (ETS Fabric) will be sold in various shades to
match different skin tones.
Bottom of Bandage
The electrodes, gauze and microbattery array are visible on the bottom side of the
bandage.
12
Adhesive Electrode Bandage Strips
Purpose and Components:
BandWave™ is composed of two adhesive electrode strips separated by a middle
gauze section. The purpose of these strips is to allow for proper connectivity with the
patient’s skin for TENS stimulation. The electrodes act like normal electrical stimulation
electrodes, connecting to the TENS power source apparatus by a female connection port,
and delivering pulsations of electrical current to the patient’s body. The electrodes have
an adhesive coating on them to allow the electrodes to properly stick to the patient’s
body, as well as to allow for proper and effective connectivity for the TENS treatment.
The electrodes will encompass the full adhesive region, separated by the middle
section that contains the electric field source (microbattery array). This design allows for
13
the electrode to maintain a large surface area of contact with the skin. BandWave™ is
intended to be used in patients with pain due to serious epidermal wounds such as
stitches, blisters, or burns, and the electrode strips allow for the bandage to provide
painrelieving TENS stimulation.
The long rectangular electrode strips are arranged on each side of the bandage,
with two connectivity ports for attaching the TENS stimulation apparatus. This aspect of
the design allows for variable bandage sizes. The bandage can be cut into two equally
sized bandages, or can be cut in any other fashion to adequately treat the intended
wounded area as long as there exists a connection port on both of the electrodes. The
TENS apparatus can be attached at any of the two connection points, which will power
the long electrode strip. This increases the usability, as well as the functionality of the
BandWave™, allowing this product to be used in the treatment of highly variable wound
types and sizes.
Dimensions:
The adhesive electrode strip is 16 cm in length by 4 cm in width. This allows for
the potential of having two bandages with an 8x4 cm electrode on each side of the
bandage, as well as many other bandages with variable widths. The electrodes and
coating adhesive gel have a total thickness of 0.3 cm. These dimensions were chosen
based on standard effective TENS electrode sizes, as well as effective thickness which
still allows for both proper stimulation, flexibility, and the ability to cut the electrode to
the desired dimensions.
Materials:
BandWave™ uses a carbon electrode coated in USA Tyco® Adhesive Gel to allow for durability and reliable connectivity with the patient's skin [3]. White wrapping paper
will cover the adhesive Tyco Gel to protect the sterility and adhesive properties of the
electrode before intended use.
14
Microbattery array and gauze section
Purpose and Components:
The middle section of the bandage, in between both electrodes, is composed of a
microbattery array. This section is intended to aid in healing wounds by promoting
regrowth of cells in the afflicted region, as well as acting as an antibacterial and antiviral
healing agent. The microbattery array forms an electric field around the wound which
stimulates cell growth and repair [4]. This portion of the bandage is modeled after the patent US 8224439 B2 microbattery array, which has proven to be an effective and
stable electric bandage. This will be licensed. The design uses silver and zinc to create an
electric field that extends across the wounded region.
There are four microbattery array strips in the center of each of the four sections
of the bandage. Above the arrays, there is a layer of gauze. The gauze prevents any
bodily fluids, such as blood, from leaking out of the bandage area. The gauze maintains
the sterility of the bandage and aids in the healing process. The cloth based microbattery
array is attached to the gauze which is part of the overlaying adhesive bandage. This
attaches the two electrodes to the middle array portion and forms one uniform cloth
bandage.
15
Dimensions:
Each of the four microbattery arrays is 3 cm by 3 cm and the gauze is 5 cm by 16
cm. The arrays are arranged in the center of each 4x13 cm section of the overall
bandage. The microbattery array is 0.2 cm and the gauze is 0.2 cm thick. These
dimensions allow for an effective electric field as well as 1 inch of gauze separating the
array from each electrode.
Materials:
The microbattery array portion of this device is a cloth based bandage lined with
conductive zinc and silver dots. The array is surrounded by medical gauze. The array,
gauze, and electrodes are attached by heated glue on the ETS bandage fabric.
Removable TENS apparatus
Purpose and Components:
BandWave™ utilizes a detachable TENS unit as a form of pain relief. The
detachable TENS unit is similar to traditional TENS units used in physical therapy and
is connected to the adhesive electrode bandage strips by two retractable connector
16
wires. This unit works by generating variable frequency and bandwidth to stimulate the
body’s peripheral nerves to block pain signals from reaching the brain and by
stimulating the production of endorphins in the body [5]. The unit also incorporates an ON/OFF button, which allows for the user to control the device when he or she requires
pain relief, and an internal LED to signal to the user that the device is connected.
Dimensions:
The TENS system needs to be 4 cm in width by 5 cm in length. This allows the
unit to cover the space between the two electrodes and to maximize the flexible area of
the bandage. The TENS system will have a thickness of 0.9 cm. The protruding wires
will have a length of 2.5 cm to allow for connectivity in all situations. These dimensions
were chosen to minimize the size of circuitry while maximizing the flexibility and overall
effectiveness of the bandage.
Materials:
The casing for the TENS system is made out of ABS plastic to waterproof the
circuitry. The protruding wire is made out of standard electrode wires. The internal
circuit is printed on a PCB board and housed inside the plastic casing. All these
materials were chosen to ensure durability and effectiveness of the system.
Coverage Film
Purpose:
The purpose of this film is to keep all the components stabilized and connected.
The film is waterproof and it prevents bacteria from coming into contact with the wound
underneath the bandage.
Dimensions:
The film is 18 cm in width by 15 cm in length. This dimension allows for full
coverage of the bandage and can also be cut based on the size of the bandage.
Materials:
17
This film is made out of a transparent adhesive film that allows the user to check
to make sure that the TENS unit is connected properly.
Manufacturing
BandWave™ will be manufactured overseas in Shanghai, China. The TENS
apparatus encasement is injection molded, the circuit will be printed and the electrodes
can be assembled by hand. These will be shipped to Voltaic Solutions’ assembly factory
where sterilized gauze and ETS fabrics will also be shipped. The assembly of all the
components in the complete device will be done by a supervised machining process.
A thin layer of glue is applied to an 1800 m roll of fabric and heated to 50C. The
glued roll is then cut into 13 cm strips. The microbattery array is cut into 3x3 cm strips
and glued onto the 5 cm width gauze. The gauze and microbattery array are then glued
to the ETS fabric, which is followed by the addition of the electrodes to the remaining
length of the ETS fabric. A coating of Tyco Gel is applied to the electrodes before they
are assembled onto the fabric, and a protective plastic cover is placed on the bottom of
the bandage. The assembled bandage is finished after being cut into its final 13x16 cm
size and is packaged into a box with one bandage, one TENS apparatus, and two film
covers per box. Once the bandages, TENS apparatuses, and film covers are packaged
into boxes, they are packaged into larger shipping boxes, and labeled with the company
name (“Voltaic Solutions”) and the destination for distribution.
Intellectual Property Strategy
Device Patentability
A patent is defined as the exclusive right to create, sell or employ a new process,
machine, manufacture, or composition of matter for a defined period of time. The
purpose of a patent is to create a contract between the patentholder and the public in
which each party benefits uniquely. The inventor benefits by establishing a monopoly
over the patented material while the public gains all relevant knowledge about the
material that would otherwise be kept private. To be considered patentable, an
18
invention must be deemed novel, nonobvious, and useful. A device is considered novel if
it is different in a significant way from any previous invention in the field. It is
nonobvious if it would be considered unexpected to someone familiar with the subject
matter, and it is useful if it will be beneficial in some way. Once these criteria are met, an
invention can be patented, thus securing a company's intellectual property, and
preventing other individuals from profiting off of it.
BandWave™ satisfies each of the three conditions listed above making its
patentability a viable option for Voltaic Solutions. Although the device combines two
existing technologies – electrically stimulated wound healing and TENS – the
combination of these two methods in a single device is revolutionary and thus satisfies
the novelty requirement. Since both technologies have been in existence for several
decades on their own and have never been previously integrated into one device,
BandWave™ may be considered a nonobvious invention. This proves that the
combination of the two methods is not obvious to a professional in the field because a
considerable amount of time has passed in which the combination has not been
successfully carried out. Lastly, BandWave™ combines the element of accelerated
wound healing in addition to pain relief, proving its usefulness as a medical device.
Due to the demonstrated patentability of BandWave™, it would be highly
beneficial for Voltaic Solutions to pursue a patent for this innovative device. The utility
patent is the standard patent type in the medical device field and is the patent that
Voltaic Solutions will pursue. The utility patent encompasses novel or improved
machines, processes, and matter, and grants the inventor a 20year monopoly on the
protected material, starting from the date of application. BandWave™ falls under the
utility patents category due to its nature as a medical device, utilizing electrical power to
achieve its end result of wound closure and pain management.
Patent Infringement
Though it is clear that the BandWave™ is itself an innovative invention, it does
utilize components, methods, and claims that products already on the market also use.
If the creation and distribution of BandWave™ is pursued without obtaining the
19
permission of the owners of these similar, patented technologies, Voltaic Solutions runs
the risk of committing patent infringement. In order to avoid infringement, we must
first determine which specific patents are at risk of being violated. From the US Patent
Collection Database, two patents were found to have claims very similar to those of
BandWave™. An additional two patents were located through the European Patent
Office relating specifically to the TENS technology utilized in our device. The analysis
and comparison of these patent claims are clarified below.
Patent 7,410,497: “Stimulation of cell growth at implant surfaces” – filed by
Hastings, et al. in August 12, 2008, describes a device that contains at least one tissue
contacting surface that is configured to undergo a variation in surface charge in
response to a signal derived from the patient. This “variation” would enhance or inhibit
cellular growth around the surface in contact. Although their claims are very general,
they still do address wound healing applications later in the patent that are very specific
to the generation of electric fields in closing cuts. Our electric bandage falls into their
first claim and overall concept of a device that changes its surface charge based on the
patient; thus, a license should also be obtained from these owners [6].
Patent 8,224,439: “Batteries and methods of manufacture and use” – filed by Skiba, et al. in July 17, 2012, presents the claim of a substrate surface that has multiple
first reservoirs of both an oxidizing and reducing agent and multiple composite
reservoirs that interact with the first reservoirs to generate current for penetration into
biological tissue. In order to do this, the device utilizes a variety of silver and zinc dots
placed on a cloth membrane. Our design conflicts with this patent because of the
method of using reservoirs to generate current in the tissue. Patent infringement on this
patent may be avoided by either creating a different way to augment the natural electric
field that the body produces or to obtain a license from the patent owner [7].
Patent US4989605A: “Transcutaneous electrical nerve stimulation (TENS)
device” – published by Rossen, et al. in February 5, 1991, describes the painrelieving
component integrated into BandWave™. Due to the fact that this patent was filed over
20 years ago, the protection offered by the patent has now expired, allowing anyone to
use and profit from the technology presented in the patent. In our case, this means that
20
we will not have to purchase licensing for the TENS technology. Our device can readily
use the circuit construction for TENS involving a microcurrent monophasic DC carrier
that can be turned on and off. We will have very similar claims: that a pair of electrodes
will be used for making surface contact with the skin and supplying electrical current in
order to alleviate pain. The voltage range and frequency may be altered from 25900
micro amps and 0.3 Hz to 10,000 Hz based on clinical trials that will demonstrate which
voltage and frequency produces the best results. It is important to note that this patent
does not claim anything with regards to increased healing speeds; its only claims are
related to pain reduction. However, our device will incorporate this TENS circuit for
both purposes. In this specific case, patent infringement is not a risk due to the
expiration of the patent, and thus, a license need not be pursued [8].
In patent US8588918: “Assembly arrangement for bandage holding a
transcutaneous electrical nerve stimulation device” – filed by Bighetti on December 16,
2010, a bandage is described that has an embedded TENS unit. The TENS device has 3
buttons to control different settings as well as an ON/OFF LED. We do have very similar
claims in that BandWaveTM has a central module fitted with a dashboard controlling electric current between two electrodes and two side tabs on the central module
opposite of each other adapted to contact the user’s body. Though this patented bandage has similar claims, BandWaveTM does not infringe on this patent’s claims because the
TENS unit is detachable and only has one current setting. Therefore, a license will not
be pursued for this patent [9].
Licensing
Licensing is understood as an agreement that grants the licensee – the individual
pursuing the license – the right to use specific intellectual property that is owned by the
licenser. There are varying strengths and durations of licenses, which are determined by
mutual agreement between the licensee and licensor. To fully protect BandWave™
against patent infringement on the specific patents described above, it is in the best
interest of Voltaic Solutions to pursue licensing of several of the specific technologies
listed.
21
For the first two patents described, different licenses should be obtained. These
components include term, territory, renewal, and exclusivity rights. Term licenses
guarantee the validity of a license for a particular length of time while territory ones
stipulate what area the rights are applicable to. The licenses can also be exclusive or
nonexclusive, depending on how much freedom the licensee wishes to pursue.
Nonexclusive licenses, however, do not completely protect the licensee because they
may still be infringing on other patents. In order to have the most competitive edge in
the market, the licenses needed to develop BandWaveTM require all of these components
and high exclusivity to block out competition. Although this would be costly, these rights
will provide the company with the niche it needs to be successful.
Trademark
An additional type of intellectual property that Voltaic Solutions, as the inventor
of BandWave™, will pursue is that of trademarks. A trademark is defined as a
distinctive visual mark that represents a particular product with the intention to provide
identification and distinguishability from competing goods or services. Unlike patents,
once attained, trademarks do not expire so long as the mark continues to be used. In the
case of BandWave™, a combination of the name and its symbol will be trademarked in
the state of California where distribution of the device will begin. The trademarked
name and logo are visible below.
22
If the dissemination of BandWave™ expands beyond California after the several
years of successful production, Voltaic Solutions will officially register the trademark by
filing an application with the USPTO in Washington, D.C.
Risk Management Process
Risk Management
Risk management is defined as a process to help designers and manufacturers
identify any possible hazards, estimate risks and develop strategies to minimize these
risks and potential for adverse events. The process is implemented as early as the design
input stage and continues throughout the entire product life cycle. Risk management is
covered in ISO 14971, ISO 13485 and the FDA’s Quality System Regulation
Requirements for Risk Analysis. The Risk Management Plan (RMP) for BandWave™
includes the identification of device components and the conditions leading to their
failure in the form of a Failure Modes and Effects Analysis (FMEA) table. Additionally, a
Risk Mitigation table is enclosed and addresses the safety hazards and failure modes
presented by the FMEA table and the steps that Voltaic Solutions has taken in order to
reduce these risks. The plan also covers acceptability criteria and a device verification process. NEED TO INCLUDE THIS
Risk Management File
The purpose of the risk management file is to provide traceability and
documentation of records of risk analysis, evaluation results, control measures for every
hazard and the acceptability of any residual risks. Voltaic Solutions has maintained this
documentation throughout the risk management process.
Risk Analysis
Risk analysis consists of documentation of the intended use and foreseeable
misuse of BandWave™, possible known hazards associated with BandWave™ and the
estimated risk for each hazardous situation identified.
23
(Put this under the FMEA table as a description)
Every individual failure and associated hazard are identified in this stage of risk
analysis and the criteria for each of these situations are defined by using an FMEA table.
The table lists each component of BandWave™ and all possible failure modes associated
with that component. Each failure was assigned ratings based on severity, probability
and detectability for the risk. Each of these categories is ranked on a scale of 15, 1 being
least and 5 being greatest. Overall relative risk was calculated using the following
equation:
isk r = detectabilityprobability×severity
(Put this under the Risk Mitigation table as a description)
For each effect of failure estimated in the risk evaluation stage, a
recommendation was made to mitigate and minimize risk for each effect by using a risk
mitigation table, seen below. Specific tasks, including preventative measures in terms of
modification of design or the system and soft controls such as labeling, training and
instructions for use, were included in this stage, plus specific descriptions for each
strategy.
Risk Management Report
The purpose of the Risk Management Report (RMR) is to be sure that the RMP is
implemented and that measures are in place to obtain production and postproduction
information.
Failure Modes and Effects Analysis
Component Substi
tuent
Comp
onent
Failur
e
Mode
Cause
of
Failur
e
Effect
of
Failur
e
Sev
erit
y
Probabil
ity
Detectability Risk Level
24
TENS Unit Plastic
Housi
ng
Plastic
casing
breaks
Stress
exceedi
ng the
materi
al’s
yield
stress
TENS
Unit is
no
longer
protect
ed and
subject
to
liquid
contact
(and
further
subseq
uent
electric
al
failure
s)
2 2 5 0.80
Printe
d
Circuit
Board
Short
circuit
Contac
t with
liquid
Therap
eutic
effect
is lost
5 1 5 1.00
Discha
rge of
curren
t into
user
5 1 5 1.00
Heatin
g of
circuit
4 1 5 0.80
25
compo
nents
leading
to
release
of
fumes
Wire
connec
tion
port
breaks
Stress
exceedi
ng the
materi
al’s
yield
stress
TENS
Unit
would
be
unable
to
connec
t to
bandag
e,
renderi
ng it
ineffec
tive
5 2 4 2.50
LED
does
not
light
up
Connec
tion
failure
within
the
system
or bulb
malfun
ction
User
would
not
know
whethe
r the
device
was
workin
g
4 1 2 2.00
26
correct
ly
ETS Fabric N/A Fabric
tears
Stress
exceedi
ng the
materi
al’s
yield
stress
Microb
attery
array,
gauze,
and
TENS
unit
may be
displac
ed
3 2 5 1.20
Loss of
adhesi
on
Manuf
acture
error:
not
enough
adhesi
ve
applied
Electro
des
and
microc
ell
arrays
displac
ed
3 2 5 1.20
Electrodes N/A Wiring
discon
nect
Cutting
of
wires
while
cutting
bandag
e to
tailor
size
Loss of
TENS
therap
eutic
effect
5 1 4 1.25
27
and
shape
Loss of
adhesi
on
Manuf
acture
error:
not
enough
adhesi
ve
applied
5 1 4 1.25
Loss of
condu
ctivity
User
error:
inappr
opriate
electro
de
placem
ent
5 2 3 3.33
Gauze N/A Tearin
g
Stress
exceedi
ng the
materi
al’s
yield
stress
was
applied
Gauze
may
tear
due to
bodily
move
ment
or
initial
placem
ent
2 2 4 1.00
28
Not
compl
etely
steriliz
ed
Manuf
acture
or
packag
ing
error
Increa
sed
likelih
ood of
infecti
on at
wound
site
3 1 1 3.00
Inadeq
uate
absorp
tion of
bodily
fluids
Absorp
tion or
size of
gauze
was
misjud
ged by
device
design
ers
Additi
onal
gauze
is
necess
ary to
achiev
e
proper
absorp
tion
2 2 4 1.00
Microbattery
Array
N/A Circuit
betwee
n
device
and
epider
mis is
not
compl
eted
Not
enough
conduc
tive
fluid
presen
t
Increa
sed
wound
healing
effect
may be
lost
4 1 2 2.00
Array
is not
in
direct
4 1 2 2.00
29
contact
with
skin
Eleme
ntal
silver/
zinc
microc
ells
detach
from
dressi
ng
Adhesi
on of
microc
ells to
wound
Possibl
e
irritati
on at
applica
tion
site
3 2 3 2.00
Manuf
acture
error:
inadeq
uate
metal
printin
g
3 1 3 1.00
Outer Film N/A Tearin
g
Stress
exceedi
ng the
materi
al’s
yield
stress
Banda
ge
longer
protect
ed and
subject
to
liquid
contact
2 2 5 0.80
Positio
ning of
TENS
device
on
2 2 5 0.80
30
bandag
e is no
longer
mainta
ined
Inadeq
uate
adhesi
on
Manuf
acture
error
Banda
ge
longer
protect
ed and
subject
to
liquid
contact
2 1 4 0.50
Positio
ning of
TENS
device
on
bandag
e is no
longer
mainta
ined
2 1 5 0.40
Risk Mitigation
Component Effect/Fault Risk Mitigation
TENS Unit TENS Unit is no
longer protected and
Manufacture stronger
plastic material
31
subject to liquid
contact (and further
subsequent electrical
failures)
Provide instructions
indicating delicate care of
the device
Short circuit:
discharge of current
into patient, heating of
circuit components
leading to release of
fumes
Protective, adhesive film
covering added to device
TENS Unit would be
unable to connect to
bandage, rendering it
ineffective
User buys a new device
User would not know
if device was working
correctly (LED failure)
User provided with
replacement device (if no
evidence of liquid damage is
found)
ETS Fabric Microbattery array,
gauze, and electrodes
unit may be displaced
Protective, adhesive film
added to device
Electrodes Loss of TENS
therapeutic effect
Provide instruction manual
including directions on how
to properly cut bandage
without cutting the wires
and how to properly place
electrodes
Apply enough adhesive
during manufacturing to
32
adhere to gauze and ETS
fabric
Gauze Gauze may tear due to
bodily movement or
initial placement
Advise that users do not
perform excessively
strenuous activity while
wearing device, especially if
placed at joint
Use higher strength material
Increased likelihood of
infection at wound site
Sterilize device properly
during manufacturing
Additional gauze is
necessary to achieve
proper absorption
Low probability: user will
have to purchase additional
gauze
Microbattery array Increased wound
healing effect may be
lost
Low probability, instruct
user to handle with care
Possible irritation at
application site
Low probability: warning
provided for users allergic to
silver or zinc
Outer film Bandage no longer
protected and subject
to liquid contact
Instruct user to employ
caution when applying
protective adhesive film and
to be conscious of bandage
placement so as not to
accidentally rip it
Positioning of TENS
device on bandage is
no longer maintained
33
Bandage longer
protected and subject
to liquid contact
Positioning of TENS
device on bandage is
no longer maintained
34
Executive Summary: Market Analysis and Entry
The bandage and wound healing markets are projected to be $39.3 billion by
2016 and will continually increase by an estimated 5.3% annually. Driven by various
factors, this industry is led by developed countries that have consistently rising numbers
of injuries per year and an aging population. More advanced bandages are in demand
due to deeper and harder to heal wounds caused by surgical cuts and deep lacerations.
With the number of surgical incisions growing at an annual rate of 3.1%, there is a need
for a more reliable dressing that can both accelerate healing and improve pain
management. In addition, the growing number of elderly and chronic diseases patients
that lack a healthy healing time and an effective inflammatory and immune response
creates a need for a bandage that reduces the risk of infection by closing the wound
more quickly. A bandage that can speed recovery and decrease pain would dramatically
reduce the chance of admittance to a hospital or care facility, saving hospitals money,
and would decrease the risk of death due to infections. Thus, for BandWave™, the
target users will be postoperative patients and their medical staff, the elderly, and
people with chronic diseases that cause skin wounds.
Using BandWave™ on surgical incisions will benefit hospitals because it reduces
the length of stay for patients as well as decreases the chance of readmittance and
followups. In addition to medical staff, BandWave™ will also be available for the
general public that can also benefit from faster healing times from normal surface
injuries, such as cuts and scrapes. Currently, the companies that dominate this market
are more focused on lowend, general care; therefore, BandWave™ could fill in the
niche for more innovative, advanced bandages. Studies have shown that while
conscious buyers are more likely to purchase cheaper, lesseffective dressings for
everyday use, they are still willing to spend more for bandages with newer technology
for more serious wounds, like surgical incisions and deep injuries. BandWave™ has
unparalleled benefits that the target users are willing to pay for, which indicates great
potential for success.
In order to be most effective in entering the market, Voltaic Solutions should
partner with either Johnson & Johnson or a growing competitor such as 3M, in order to
expand the consumer base and reach a larger market than would be possible by
35
operating as a small, distributionbased company. While BandWave™ is innovative and
can drastically save unnecessary costs due to infection and lessadvanced bandages, this
product must first catch the attention of both the hospital staff as well as the general
public. With connections and resources from a bigger, more established company, the
demand and return for BandWave™ could be exponentially bigger than if Voltaic
Solutions tried to break into an established market by itself. However, in order to be
recognized by Johnson & Johnson or 3M, Voltaic Solutions must become recognized
through sales representatives hospital visits, convention appearances, public
demonstrations, advertisements towards the target users, and social media. In addition,
special attention and presentations will be given to surgeons in order to gain support
and acceptance of the product in the medical and wound care fields. With backing from
both users and medical professionals, Voltaic Solutions and BandWave™ could become
large enough for bigger device companies to partner with or purchase. BandWave™ has
the potential to help an industry giant further innovation and fill the other advanced end
of the bandage spectrum.
The Bandage Market
The current bandage market consists of a large portion of wound management
products. Dominated by temporary, adhesive dressings for everything from light
scratches to surgical sites, the total value of the global market for these types of devices
is increasing annually by 5.3%. In 2016 alone, the world demand for healing agents and
products is projected to be $39.3 billion (Freedonia) 10. Led by the United States, developed regions will account for a large portion of the market while demand increases.
The growth of the bandage market has been largely been driven by the rapidly
increasing number of surgeries per year and recreational activities by all age groups.
Surgical wounds alone have been growing at an annual rate of 3.1% (Mediligence 11). Rising incidences of chronic diseases such as diabetes and obesity, which can cause
chronic diabetic ulcers, along with the increasing number of wound infections, creates a
need for innovative bandages that facilitate faster and more advanced healing.
BandWave™ would drastically improve the current state of wound recovery by
36
accelerating wound closure, decreasing rehabilitation time, and reducing the rate of
pathological infection.
Other drivers of the wound healing market are the rapidly increasing populations
of older adults and people with diabetes or HIV. The estimated population of elderly
individuals from 2012 will double to 83.7 million by 2050 (Ortman 12). Although older adults can heal most wounds, they have drastically slower healing times and a delayed
inflammatory immune response. Because of this, the elderly are much more susceptible
to infection and further injury. Patients with illnesses such as diabetes or HIV also have
weakened healing and less protection against bacterial or fungal infection. About 33%
of the current 29.1 million diabetics in the United States will have a skin disorder or
wound in their lifetimes (dailyRX, CDC 13). BandWave™ would aid in remodeling and
recover lost healing time in order to counteract these age and diseaserelated
differences.
The bandage market is extremely broad and highly aggressive. However, with so
many factors driving it, the market has several, specific niches that can still be explored
and filled. Many of the industry leaders have shifted their focus to more general, at
home care, leaving the advanced bandage sector relatively untouched. BandWave™
would advance the bandage industry by incorporating novel woundhealing technology
and reduce the significant economic burden of common wound and surgical site
infections, which extend the lengths of hospital stays and increase the costs of treatment
(de Lissovoy 14). Market Needs
Currently, normal and general bandages would heal by only covering the wound.
They keep the injured skin from drying out and prevent exposure to dirt and germs;
however, they do not aid in pain management or accelerated cell proliferation and
remodeling. For postoperative patients, the elderly, and those with open wounds, it is
crucial to minimize healing time to reduce hospital stay and complications from
infection and scarring. As the populations of these groups grow, BandWave™ can help
solve the following newer, unmet needs:
37
Accelerated Wound Healing: The technology for bandages has been unchanged for years. By limiting the wound’s exposure to the air, bandages serve as a barrier
against bacteria and water while the skin heals; however, they do not help granulation
tissue migrate and differentiate. BandWave™ helps the proliferative phase of healing by
augmenting the body’s own electrical healing process. When the epithelium is
disrupted, the skin naturally creates an endogenous electric field across the wound with
the negative potential focusing near the center axis of the incision. Cells are drawn
towards each other from both sides of the incision where they begin reepithelialization.
BandWave™ increases the electric potential of the skin around the wound to better
direct and accelerate cell movement. Faster wound closure would not only speed
recovery time, but it would also reduce chances for infection and save hospital stay
costs.
Reduced Pain: Most bandages in today’s market do not have an effective pain reduction system. Although many have a layer of antiseptic gel on the inner layer of the
dressing, users generally have to combine the bandage with pain relief ointments and
sprays, like Neosporin or Bactine, or oral medication, like Advil or Tylenol. Oral
medication is not recommended because it affects the entire body instead of a localized
area. BandWave™, which utilizes an electricbased structure, solves this problem by
using transcutaneous electrical nerve stimulation (TENS) technology. The
microcurrents and pulses stimulate nerves noninvasively to reduce both acute and
chronic pain. For postoperative patients, the first stage in healing the inflammatory
phase causes warmth, swelling, and pain. With BandWave™, the pain can be
dramatically reduced.
Reduced Scarring: Scars are naturally formed when collagen fibers begin the remodeling new skin across the damaged skin. When wounds take a long time to heal,
the body can produce too much collagen, causing scars to be hypertrophic or raised.
Faster–healing injuries would therefore reduce scarring. BandWave™ would improve
the appearance of the skin after healing.
38
Customization: If a patient has two different sized injuries, he or she must purchase two different kinds of bandages because they are mostly sold in specific
dimensions. In addition, most are only secured on two sides of the dressing, leaving the
two other edges exposed to water and germs. BandWave™ solves this issue by giving
the user size options. The large bandage strip (16 by 13 cm) is has perforations to direct
the individual to cut the bandage for different parts of their body or for different sized
wounds. The large bandage can be cut into two separate bandages (three different
potential sizes) and the TENS can be used on both bandages. This allows flexibility for
the user as well as a high range of uses.
Reusability: Because dressings are continuously absorbing fluids from the wound, they need to be changed often to decrease the risk of contamination. Thus, most
general bandages are disposable and indicated for onetime use. While the dressing and
gauze portion of BandWave™ should be changed regularly to discourage infection, the
TENS unit is removable and can be reused for new dressings. Because the TENS unit is
reusable, each package of BandWave™ will be sold with one TENS unit and multiple
bandages.
Target Market and Users
Postoperative patients and older adults purchase a significant number of
bandages, especially highend adhesive bandages, each year. Approximately 40 million
surgeries that require incisions are performed in the United States per year (CDC 15). The length and size of these surgical cuts range from a quarter of an inch to 8 inches
with an average of 3 inches (SSM). BandWave™ fits into this market niche by providing
protection, healing, and pain management for up to 6 inches of a wound or surgical
incision. Because the skin serves as a natural barrier against bacteria and other harmful
toxins, surgical sites are much more likely to develop an infection within 30 days after
surgery (Hopkins). Because BandWave™ both increases recovery time and provides
effective pain management, physicians are more likely to recommend and use it to
decrease hospital stay and reduce the chance of infection and costly followups. Thus,
the primary targets are postoperative patients and their physicians.
39
The more general users would include the elderly and those with chronic diseases
that cause epithelial wounds. One out of three older adults aged 65 and older fall each
year (NIH Senior Health). Twenty to 30% of those who fall suffer moderate to severe injuries that include deep lacerations, hip fractures that require surgery, and head
traumas (CDC). People with diabetes or HIV also have delayed immune responses and weak remodeling systems. Diabetic and pressure ulcers have tremendous consequences
and costs (Diabetes). The Center for Medicare Services estimates that the average cost per ulcer for Medicare patients was $43,180 in 2007 (Armstrong). These wounds, if not healed quickly, can lead to hospitalization or longterm facility care, and they also
increase the risk of early death. BandWave™ could significantly reduce these risks with
its wound healing technology. With it’s large size and easy application, BandWave™ can
be applied to any site or kind of injury, including small cuts, surgical incisions, and even
pressure ulcers. Due to their slow healing time and decreased immune response, the
elderly and people with diseases like diabetes or HIV will be a part of the target market.
Marketing Design: Logo, Packaging, Label
In order to attract target users, the product and packaging should incorporate
graphics or eyecatching designs that stand out against similar products and imply
safety and comfort. The logo for Voltaic Solutions can be seen below:
This design is simple and comprised of basic shapes, including yellow O’s, which
are calming and appealing against the sharper edges of the other letters. The yellow
color reflects the symbolic color of electricity, which is a major technological part of the
BandWave™ design. The clean, wide font can be used on a range of backgrounds, giving
flexibility to its application on packaging as well as advertisements.
For the BandWave™ brand, the logo is displayed below:
40
Because of all the potential applications, this logo is also versatile and can work
on a variety of background colors. Even if the font is very small, it is still distinct enough
to be legible. While the overall ‘Greek Cross’ shape is a distinctive sign for first aid and
medicine, the blue ripples within the medical cross symbolize waves of regeneration.
The packaging for BandWave™ can be seen below. On the front, the logos for
BandWave™ and Voltaic Solutions and a brief description of the product stand in
contrast against a comforting yellowgreen background. A small viewing window made
of plastic is also on the front to show the portable TENS control unit. On the side panel,
there is a list of injuries and wounds that BandWave™ can be used for. Explanations
about the two technologies incorporated into the product are on the back of the box,
along with a warning for users allergic to zinc or silver. Customers that are interested in
learning more about BandWave™, Voltaic Solutions, and associated products can scan
the QR code which will direct them to the website. This will also be the way in which
patients and users can interact with the company by offering questions, concerns, and
feedback.
41
The back side of the packaging describes the technology and the mechanisms of
action employed by BandWave™ so that the consumer has a better understanding of the
benefits of using this product. The labeling is as follows:
What is TENS?
TENS is a pain management therapy that send gentle electrical pulses through the skin
to reduce pain in the area of application. Pain is reduced by blocking pain signals from
reaching the brain and by stimulating the release of endorphins, the body’s natural
painkillers.
What is microcurrent technology?
Microcurrents are small loops of weak electrical that are generated where the bandage
contacts the skin. These currents are generated by elemental silver and zinc microcells
printed on the bandage when they are moistened. These currents stimulate cell
regeneration to speed up the healing process, and reduce scarring.
Package Contains:
42
Reusable TENS stimulator device
Once 13cm by 16cm bandage
Two adhesive film covers
The bandage can be cut along the specified lines to tailor its size and shape to your
needs.
Read directions carefully before use.
WARNING: This product contains elemental silver and zinc. Those with allergies to
these metals should not use this product.
Marketing Materials
Marketing campaigns must be targeted at both medical staff and general
consumers in order to tackle the largest market. Voltaic Solutions will use various
methods in gaining recognition and acceptance in the bandage market. For the rollout
of BandWave™, the following strategies and materials will be implemented.
Sales Representatives: The best way to help BandWave™ gain attention is to have sales representatives show consumers how effective it is compared to current bandages. To do this, product demonstrations will be made in classes, medical device and healthcare conferences, advertisements, hospitals, and more to promote acceptance of the product (Research&Markets 21). Sales representatives will start by visiting hospitals and care facilities around the Los Angeles region to start a local following. As the business grows, other sales teams can be established throughout California, and eventually throughout the country to start redefining the standard for wound healing and pain management.
Advertisements: To gain attention and establish BandWave™ as a commonly
used product, BandWave™ needs to be advertised in media and areas that are
associated with the target users. Because the primary intended consumers are
postoperative patients, surgeons, nurses, and other medical staff, these groups must
43
learn about this product. Therefore, magazines such as The American Journal of Surgery, Outpatient Surgery Magazine, and Surgical Products Magazine would give exposure to this new product to those who could recommend the product to patients.
To target the more general consumers (the elderly or people with chronic diseases),
magazines such as Living Well Magazine, Diabetes Forecast, and HIV Plus Magazine will help in giving BandWave™ a name.
Pamphlets/Brochures: Along with advertisements, pamphlets and brochures will be distributed in areas that are often frequented by the target users. These would
include hospitals, elderly care facilities, pharmacies, and health clinics. Laced with facts
and testimonials, these fliers will get customers interested and excited about
BandWave™. When they shop for bandages, they will be more familiar with the product
and recognize it among other bandage types.
Social Media: To appeal to users of all ages and demographics, BandWave™ and
Voltaic Solutions will have a broad social media presence. Through the website,
Facebook, Twitter, Instagram, and other social media platforms, customers will be able
to learn more about the company, the products, and the technologies, and to ask
questions or share testimonials. These platforms will also allow users to interact with
designers and engineers to encourage product improvement. Every advertisement,
brochure, and product packaging will include QR codes to ease access to these sites.
Market Competition
Currently, the biggest companies in the wound management and bandage market
are Johnson & Johnson, 3M, and several private labels. Medical device giant Johnson &
Johnson has a brand of adhesive bandages named BandAid®, which has become a
genericized trademark for any kind of wound dressing. Although J&J has dominated
the bandage market for decades and holds a 55% market share today, 3M has been
edging them out with more innovative bandages. 3M now has a 13.8% share of the
market by shifting its focus to home care and redeveloping dressing technologies used in
hospitals. Although 3M only entered the consumer bandage market four years ago, they
44
have already gained enough ground to become the second largest company in the
bandage market. Private labels make up approximately 13.6% of the market with the
rest being other labels (Hua 22).
In addition to the adhesive bandage giants, there are several smaller companies
that are utilizing electric field and microcurrent technology in their dressings. Vomaris
Innovations, Inc. has a brand called Procellera which sells bandages that have both
silver and zinc on the device surface. This matrix of metal dots creates multiple
microbatteries that generate currents that recruit new cells and promote recovery.
Vomaris also recently partnered with Arthrex, Inc., a global medical device company in
orthopaedics and sports medicine (PR Newswire 23). They are strong competition against BandWave™; thus, BandWave™ could benefit from partnering with other
bandage companies for a better chance of success.
Market Penetration and Entry
The most conscious buyers of bandages are those looking for general use,
lowend adhesive bandages. Many private label brands have headed towards this end of
the market to cater to these buyers; however, consumers of highend, “smart” bandages
are more willing to pay higher prices in order to gain the additional benefits of more
advanced products. BandWave™ has high potential in leading the advanced bandage
market niche. For BandWave™ to be successful, however, the market entry must be
aggressive.
There are two main possibilities for BandWave™ to penetrate the bandage and
wound healing market. The first mode of entry would be to independently market,
manufacture, and sell the new bandage directly to the target users: physicians,
postoperative patients, people with chronic diseases, and the caretakers of the elderly.
Everything from clinical trials to focus groups to building relationships with hospitals
and stores would be done solely by Voltaic Solutions.
The second mode of entry would be to partner with an existing company in the
bandage market. Because Johnson & Johnson is the leader of the wound management
45
industry, Voltaic Solutions could benefit greatly from partnering with them and helping
them fill their need for more innovative and advanced products. In doing so, Voltaic
Solutions would not have to purchase their own factories or penetrate an established
market that has been consistently controlled by only a handful of companies. Because
Voltaic Solutions would have already assumed the risks and funded the clinical trials
and all of the regulatory and quality paperwork, BandWave™ would be fully developed
and FDA approved. Thus, BandWave™ would be established and attractive to Johnson
& Johnson, which can partner with Voltaic Solutions for licensing and distributing
rights or purchase it altogether. With 3M slowly capturing more of the bandage market,
Johnson & Johnson could use BandWave™ to regain their control of the advanced
dressing niche. The cost of just bringing BandWave™ to market would be too much for a
startup; therefore, the second mode of entry would be more successful.
46
Sources
Freedonia.
http://www.freedoniagroup.com/WorldWoundManagementProducts.html
Freedom&Markets.
http://www.researchandmarkets.com/reports/365799/u_s_adhesive_bandages_mark
et
Hua. http://articles.latimes.com/1998/sep/10/business/fi21303 CDC. http://www.cdc.gov/nchs/fastats/inpatientsurgery.htm Hopkins.
http://www.hopkinsmedicine.org/healthlibrary/conditions/surgical_care/surgical_site
_infections_134,144/
Mediligence.
http://blog.mediligence.com/2009/08/24/surgicaltraumaticburnandchronicwoun
dsdrivingwoundcareproductsmarket/
Ortman. http://www.census.gov/prod/2014pubs/p251140.pdf de Lissovoy. http://www.ncbi.nlm.nih.gov/pubmed/19398246 CDC AdultFalls. http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html PR Newswire.
http://www.prnewswire.com/newsreleases/vomarisandarthrexannounceexclusive
globaldistributionagreementforprocelleratechnology300028013.html
CDC Diabetes. http://www.cdc.gov/diabetes/data/statistics/2014statisticsreport.html dailyRX. http://www.dailyrx.com/diabetespatientshaveincreasedriskskinproblems Armstrong DG, Ayello EA, Leask Capitulo K,Fowler E, Krasner DL, Levine JM, Sibbald G, Smith APS, Opportunities to Improve Pressure Ulcer Prevention and Treatment: Implications of the CMS Inpatient Hospital Care Present on Admission (POA) Indicators/HospitalAcquired Conditions (HAC), Policy Wounds 2008;20(9):A14A26.
47
Executive Summary: Regulations and Clinical Trial Strategy
BandWave™ will be submitted to the FDA as a Class II medical device. This
classification requires adherence to regulatory requirements known as general and
special controls. General controls were enacted through the FD&C Act and include
regulations on subjects such as adulteration, misbranding, and records and reports on
devices. Special controls include topics such as performance standards, postmarket
surveillance, and the creation of patient registries. The purpose of each of these types of
controls is to set a standard for device design, manufacture, and distribution.
An essential part of the FDA device submission is submission of the 510(k), which
establishes substantial equivalence of BandWave™ to one or more predicate devices
already on the market. The 510(k) submission will include a CDRH Premarket Review
Submission Cover Sheet, a 510(k) Acceptance Checklist, and a detailed statement on the
indications of use for the device. However, the bulk of the 510(k) submission for
BandWave™ will be focused on its substantial equivalence to two different predicate
devices, Vomaris Innovations Inc’s Procellera® Wound Dressing (510(k) # K130350)
and Hivox Biotek Inc’s RapidRelief™ Pennypad® (510(k) # K140650) device. The
former device was chosen for its equivalent method of employing microcurrent
stimulation for wound closure and the latter for its utilization of TENS technology.
These two predicate devices together can be used to justify substantial equivalence for
BandWaveTM.
In order to ensure that the design and manufacture of BandWave™ meets the
standards set for distribution, Voltaic Solutions will adhere to the Good Manufacturing
Practices (GMP) and Quality System Regulation (QSR) processes set in place by the
FDA. Voltaic Solutions has established design controls, component specifications, and a
formal labeling control process to guarantee a high quality final product and to comply
with these FDA regulations. Additionally, a process quality system has been established
to oversee a multitude of different manufacturing processes. An essential part of the
quality system regulation process is that of maintaining formal documentation of the
manufacturing process. For the production of BandWave™, documentation will be
maintained in the form of Design History Files (DHF), device master records, history
48
records, maintenance schedules, complaint files and personnel training records to verify
that procedures have been accurately fulfilled. Lastly, the approval and quality
acceptance of the final product is achieved by verifying the quality assurance of all
procedures performed.
In order to move forward with device production, an Investigational Device
Exemption (IDE) must be obtained to allow BandWave™ to have the opportunity to
advance with human clinical trials. Clinical trials will begin with in vitro testing of
BandWave™ as a means of determining the biocompatibility of this device without
posing any risk to living animals or humans.
Once the biocompatibility of BandWave™ has been demonstrated through in
vitro testing, animal testing will be performed to further demonstrate the
biocompatibility of this product.
Assuming all in vitro and animal testing have yielded favorable results, Voltaic
Solutions will move forward with human clinical trials of BandWave™. Unlike the in
vitro or animal testing, the human clinical trials must first be approved by an
Institutional Review Board (IRB) before Voltaic Solutions may proceed with actual
testing. A first round of clinical trials will be performed to evaluate the biocompatibility
of the device and a second round of trials will investigate the effectiveness of the
technology in order to develop marketing claims. To yield the most characteristic results
of the proposed market, it is essential that the subjects used for the human clinical trials
are representative of all demographic backgrounds. This will be achieved by using
randomly sampled subjects.
Device Classification — Class II Device
All medical devices are classified by the FDA. The purpose of the device
classification system is to ensure that higher risk devices are subject to more inspection
than lower risk ones. Device classification is determined by the safety, the complexity,
and the historical experience of the device in question. Classification is broken up into
three categories: Class I, Class II, and Class III.
49
Description Market
Share
Regulatory
Controls
Approval
Process
Class
I
Safest devices 46% General controls No FDA
approval
needed
Class
II
Some risk due to misuse 46% General controls and
special controls
FDA clearance
required
Class
III
Serious injury or death
may result from misuse
8% General controls and
premarket approval
FDA approval
required
Device classification is based on the primary intended use of the product, rather
than all possible applications. BandWave™ will be submitted to the FDA as a Class II device. It will be classified as a Class II device because although there are no
lifethreatening risks associated with misuse or failure of this device, there is a greater
potential for harm than most Class I devices. Because of the circuitry involved in this
bandage, the device could pose a greater risk to patients than regular bandages, which
are Class I devices. As a Class II device, BandWave™ is subject to both general and
special controls.
General controls are regulatory requirements created by the FD&C Act. General controls include such things as adulterated devices, misbranding, registration of device
producers and premarket notification requirements, banned devices, notifications,
recalls, and other remedies, records and reports on devices, and general provisions for
devices intended for human use. All devices, regardless of classification, are subject to
these regulations.
Special controls for class II devices are typically specific to device categories.
These controls include performance standards, postmarket surveillance, patient
registries, specific labeling requirements, premarket data requirements, and other
guidelines. Class II devices are exempt from premarket approval (PMA).
General Controls
50
Adulteration
Adulteration is defined under Section 501 of the FD&C Act. A device is
adulterated if it contains any filthy, putrid, or decomposed substance, or if it is prepared
or packaged under any unsanitary conditions.
Misbranding
Misbranding is covered under Section 502 of the FD&C Act. A device is
misbranded if the labeling is false/misleading, its packaging does not bear a label or its
label does not bear adequate directions for use.
Registration of Device Producers and Premarket Notification Requirements
The medical device manufacturers must submit a list of all devices produced and
register their establishments to the FDA. The FD&C Act requires the manufacturer to
submit a 510(k) to the FDA at least 90 days before introducing the device into the
market.
Banned Devices
The agency is authorized to ban any device that presents substantial risk of illness
or injury. If the device presents a risk and can be corrected by a change in labeling, the
agency will notify the person responsible for the risk or deception. If the labeling is not
changed in the specific time period in which the change should be made, the agency may
affirm, modify or revoke the regulation. In the case where the final regulation is
published, the device will be banned and cannot be legally marketed.
Notifications and Other Remedies
Section 518 is meant to protect public health and also provide a compensation
process for customers who have been sold defective medical devices. The FDA will
require manufacturers to provide all health information and risks to health
professionals who use the device. FDA may order a notification if the device presents the
potential for public harm and may follow a set of procedures including repair,
replacement or refund notifications.
Records and Reports on Devices
Section 519 requires manufacturers to maintain records and reports to avoid any
adulterated or misbranded devices. These records should include the purpose of
submission of information and procedures.
Restricted Devices
51
Section 520(e) allows the FDA to restrict the sale, use and distribution of a
medical device if there is no assurance of safety and effectiveness. If a device is
restricted, it may still be authorized to be sold by a licensed practitioner under regulated
conditions.
Special Controls
Performance Standards
Under Section 514, performance standards for a Class II device include
reasonable assurance of safety and effective performance, periodic evaluation,
establishment of a standard and recognition of a standard.
Postmarket Surveillance
Conducting postmarket surveillance for any Class II or III device may be ordered
if the device could potentially lead to any serious adverse health consequences, have a
significant amount of usage in pediatric populations, if the device could be implanted in
the human body for more than a year or if it is a lifesustaining device used outside the
user.
Patient Registries
Patient registries are meant to track outcome data from device usage and are
designed to give manufacturers information about characteristic populations in which
BandWave™ is used.
510(k) Application
FDA Submission Report
As part of the traditional 510(k) submission, a Medical Device User Fee Cover
Sheet (Form FDA 3601) will be submitted along with a CDRH Premarket Review
Submission Cover Sheet as the cover pages of the 510(k) submission. The CDRH
52
Premarket Review Submission Cover Sheet includes information such as the type of
submission, applicant contact information, reason for application, information about
predicate devices and substantial equivalence, product classification, manufacturing and
packaging information, and standards recognized. A table of contents will be included
after the cover pages.
FDA Registration
Voltaic Solutions will submit electronic registration to the FDA as a producer of
medical devices as well as a payment of $3,646 for the year of 2015. The company will
also follow up with annual reregistration subject to 21 CFR Part 807. Companies are
required to register themselves as producers of medical devices to maintain
transparency and offer a method of holding companies responsible for adverse events
associated with their device(s), commensurate with section 510 of the FD&C Act.
Device Classification
BandWave™ will be classified as a Class II device because the electronic
components pose a greater risk than most Class I devices, yet is not life sustaining or life
threatening enough to be classified as a Class III device. The BandWave™ product is a
combination of TENS therapy and electrical stimulation for wound healing. The TENS
component is the primary mode of action and therefore the device will submitted under
regulation number 21CFR882.5890, which includes transcutaneous electrical nerve
stimulators for pain relief. TENS devices have been cleared by the FDA for OTC and
prescription use from as early as 1979 and have been continually improving since, with
multiple new devices given clearance every year. BandWave™ is a further improvement
to past devices and will continue the evolution of this technology.
Predicate Devices
The BandWave™ 510(k) submission will make use of two predicate devices, as
the device is a novel combination of two preexisting technologies. Voltaic Solutions will
utilize the Procellera® Wound Dressing (510(k) # K130350) as the predicate for its
53
microcurrent wound healing component, and Hivox Biotek Inc’s RapidRelief™
Pennypad® (510(k) # K140650) device as predicate for the TENS component.
Wound Healing Predicate Overview
The Procellera® Wound Dressing provides microcurrent stimulation to the site
of a wound, promoting cell proliferation and migration, subsequently speeding up the
healing process. The dressing is primarily constructed from an antimicrobial polyester
substrate. Embedded in this material is a matrix of biocompatible microcells (composed
of elemental zinc and silver) which produce a predetermined amount of current at a
voltage similar to that observed in skin injuries. The microcells produce this stimulation
in the presence of a conducting fluid such as wound exudate or exogenous fluids,
including saline. The dressing also conforms to the wound for maximum mobility and
comfort. As an OTC product, the wound dressing is intended for the management of
superficial wounds such as minor cuts, scrapes, abrasions, blisters, etc. In clinical
settings, the wound dressing is applicable to surgical incisions and chronic or more
serious wounds. (510(k) # K130350) (http://procellera.com/procellera/technology)
TENS Predicate Overview
Hivox Biotek Inc’s RapidRelief™ Pennypad® TENS device generates small
pulses of electrical current and delivers this current through the skin to activate
underlying nerves for the regulation of pain. The electrical stimulation is provided
through two selfadhering conductive electrode pads which are connected through
wiring extensions to the pulse generator. Multiple stimulation parameters, such as pulse
width, time, and intensity, are programmable into the device. To stimulate a desired
location on the body, the electrode pads are placed in such a manner that the source of
pain lies between them. The stimulation activates peripheral nerves to block pain signals
from being sent to the brain and stimulates the release of endorphins. The
RapidRelief™ Pennypad® is intended for temporary relief from pain. (510(k) #
K140650)
BandWave™ Overview
54
Voltaic Solution’s BandWave™ product is a bandage with electrical components.
A circuit attached to the bandage (TENS Unit) generates pulses of electrical stimulation
which are applied to the skin and underlying peripheral nerves. This electrical
stimulation of the nerves blocks pain signals from being sent to the brain and stimulates
the release of endorphins. In addition to TENS pain relief, BandWave™ uses an
antimicrobial polyester gauze as primary contact with the skin/wound surface. This
gauze is embedded with a matrix of microcells of elemental zinc and silver. These cells
produce measured microcurrents at voltages that are slightly elevated compared to
those specific to naturally healing wounds in the presence of conducting fluid.
Statement of Indications for Use
The indications for use (IFUs) are statements that will be included on the label of
all devices under the brand name BandWave™ that are produced by Voltaic Solutions.
BandWave™ is intended for the temporary relief of localized pain and management of
wounds, increasing healing speed. BandWave™ is indicated for use with any
nonmucosal breached surfaces of the human body. It may be placed over a section of
the epidermis where the skin has been breached. BandWave™ may be used in clinical
settings by a physician’s assistant or nurse, or it may be used in nonclinical settings
(OTC) by the patient himself. The target population for this product is all people ages 12
and up. For patients under the age of 12, this product is not recommended. These
bandages are indicated for onetime use and it is recommended that each bandage be
changed approximately every 5 to 7 days. The TENS unit is reusable until the LED no
longer lights up with application to the bandage.
Substantial Equivalence
BandWave™ is substantially equivalent to the Procellera® Wound Dressing
because there exists no change in the design and technology, nor the intent for use. The
same material is used in both products in the same manner and for the same purpose.
The only difference is that the dressing’s effect is a secondary action to the TENS in
BandWave™. BandWave™ is substantially equivalent to the RapidRelief™ Pennypad®
55
because both utilize the pulsing stimulation characteristic of TENS devices.
BandWave™ operates within the same electrical specification bounds and through the
same mechanism as the predicate device, albeit on a smaller, more portable scale. The
novel combination of these two technologies has no impact on the safety and efficacy of
either component, and serves as a significant improvement over each device
individually.
Predicate Chart Comparison
Device Name Rapid ReliefTM
Pennypad PP904
BandWave™™
Indication for
applied area for
pain relief
Arm, Leg, and Lower
Back
Epidermis surrounding open
wound
Dimensions 113L*70W*9.7H mm 160L*40W*3H mm
Waveform Symmetrical Biphasic Monophasic
Shape Rectangular
Maximum
Output Voltage
(Volts) (±20%)
57.6Vpp @500Ω 45Vpp @500Ω
89.6Vpp @2KΩ
96.0Vpp @10KΩ
Maximum
Output Current
(±20%)
115.2mA @500Ω 50mA @2kΩ
44.8mA @2kΩ
9.6mA @10kΩ
Pulse Duration
(μSec)
200 μSec (fixed) 90uSec (fixed)
56
Frequency (Hz) 2, 5, and 40 60
Net
Charge
(μC) per
pulse
@500
Ω
0.2304 .1208
Maximu
m
Charge
(μC)
@500
Ω
23.04 12.08
Maximu
m
Current
Density
(mA/cm2, r.m.s)
@500
Ω
2.828 1.633
Maxium
Average
Power
Density
(W/
cm2)
@500
Ω
0.163 0.095
ON Time (sec) 120 75
OFF Time (sec) 0 0
Additional
Features
N/A Wound Healing
Quality System Regulation Requirements
57
Voltaic Solutions has established a set of quality regulations that are put in place
in order to assure that all products designed and manufactured by the company are held
up to high standards and have an acceptably low probability of failure.
The manufacturing of BandWave™ complies with current good manufacturing
practices (CGMP’s) and the FDA’s Quality System Regulation and global ISO Standards.
The QSR process will be monitored and inspected by the FDA to affirm compliance with
these requirements. Performance requirements will be established before production of
the device. During the manufacturing process, manufacturers should ensure that device
components are compatible with each other. Adequate packaging materials will be
selected once production is completed. Quality system report documents will also be
provided to the manufacturers to ensure compliance with CGMPs. These documents
include, but are not limited to, employee training procedures, cleaning/sterilizing
procedures, safety procedures, general design control procedures, workmanship
standards and inspection procedures.
Design Controls
The manufacturing engineers at Voltaic Solutions will establish and maintain
design control procedures for BandWave™. A product assurance system and
production/design QA system will be established. The quality system team will play a
role in the review, evaluation and documentation of the device design with development
and validation data through customer feedback. Any adverse events will be reported to
the FDA (21 CFR Part 803 Medical device reporting).
Component Selection
The specifications for component and raw material selections included in the
design phase will include valid and wellunderstood methods of sampling and
acceptance so that there is no confusion with suppliers, contractors, and consultants, in
order to create high quality final products. This process will lie mainly in the hands of
manufacturers who will establish procedures to ensure that the raw materials will meet
the specified requirements.
58
Labeling Content
To insure compliance with the FD&C Act, a formal labeling control process will
be established, in which any software and printing labeling is reviewed prior to its use,
in order to meet regulatory requirements. The use of correct labels and attachment will
be ensured through this process.
Process Quality
The process quality system will cover a number of manufacturing processes such
as welding, molding, lyophilizing, sterilization, and packaging in addition to validation.
These methods will be implemented before production and will be documented
throughout the production process as well. Any adverse effects during this stage will be
identified followed by acceptance methods that the quality engineers will implement.
Management Responsibility
Manufacturing managers have the executive responsibility of maintaining an
organized structure of all personnel involved in quality assurance and manufacturing in
accordance with GMP requirements. They must ensure that quality system
requirements are established and maintained continuously throughout the
manufacturing process.
Formal and Documented Quality System
Keeping records such as design history files (DHF), device master records,
history records, maintenance schedules, complaint files and personnel training records
is essential and will be maintained throughout the quality system process. Device
history will be reviewed to verify that the procedures were properly conducted.
Approval and Quality Acceptance of Product
59
All tests and processes must be performed correctly and inspected afterwards.
After quality assurance of the procedures including packaging, labeling and materials
has been conducted, finished devices are ready to be approved for use.
Employee Training
Any personnel involved in quality system activities must given formal training
and be wellequipped and able to identify, evaluate and solve any quality system
problems that may arise. Additionally, employees must be able to verify solutions to
these quality problems. The manufacturing line where the BandWave™ products are
made will be equipped with detailed instructions for the manufacturing procedure,
including both text and visual diagrams.
Clinical Trials Regulation
Preclinical Testing and IDEs
An Investigational Device Exemption (IDE) permits a device that has not yet
been submitted to the FDA via a premarket notification to be used for investigational
purposes in human clinical trials. IDEs are required for all significant risk devices that
will be used in human clinical trials. However, an IDE application is considered
automatically approved if the device is not considered a significant risk device (U.S.
Department of Health and Human Services). The designation of a device as “significant
risk” or “not significant risk” is determined by the IRB. If the device is not a significant
risk device, the sponsor must label the device in accordance with 21 CFR 812.5. In
addition, approval of the IRB and informed consent of all human subjects are required
in order to conduct a study with this device (U.S. Department of Health and Human
Services). Voltaic Solutions will present to the IRB a justification as to why the
BandWave™is not a significant risk device and if this justification is accepted, then an
IDE application will not need to be submitted. The justification for why BandWave™ is
not a significant risk device is that it does not present a potential for any serious risk to
human health or safety, as defined in 21 CFR 812.3.
60
Biocompatibility
Biocompatibility should be established for a device as a whole and not merely the
individual components and materials of a medical device. Biocompatibility will be
established through both nonclinical (in vitro) and clinical trials using either the device
as a whole or an extract of the device.
Model Feasibility, Safety and Efficacy Testing (In Vitro)
Purpose/Scope
The purpose of in vitro biocompatibility testing is to establish
biocompatibility of this device in a way that does not pose any risks to living animals or
humans. Cytotoxicity is the only test that is able to be performed in vitro before
beginning animal trials. The reason for this is that the other tests that will be performed
in animal and human clinical trials study the immunological response to the material,
which cannot happen in a sample of cells.
Materials and Methods
1. Cytotoxicity
The device to be tested will be made into an extract to concentrate the
chemicals found in the device, and this extract will be used in this study. ISO 1099312
details the procedure by which extracts must be made for use in clinical studies. The
device to be tested should be a representative sample of a finished product, including
any coatings, surface treatment, sterilization, etc. that are performed on a product
before it is sold. Two extracts will be made: a physiological saline solution extract, and a
vegetable oil extract. These solvents are recommended by ISO 1099312 because the
saline solvent will create an extract from the polar materials in the device, and the
vegetable oil will create an extract from the nonpolar materials in the device. Both of
these solvents are harmless to cells.
The figure below shows the recommended extraction ratio, expressed as the ratio
of the surface area or mass of the test sample to the volume of extractant used, for
various materials and thickness of the part.
61
Extractions of highdensity polyethylene will be used as negative controls, since
this material is recommended in ISO 1099312 and has been shown to have no toxic
effects on cells or tissues.
Invitro cell cultures will be prepared and soaked in each of these extractions:
saline extraction of device, vegetable oil extraction of device, saline control (highdensity
polyethylene extraction), and vegetable oil control (highdensity polyethylene
extraction). The parameter to be measured is cell growth inhibition. If the cell growth is
not inhibited, this indicates that the device extraction is not cytotoxic (Medical Device
and Diagnostic Industry).
Animal Testing
Animal studies are required by the FDA for medical devices which contain
materials not known to be biocompatible with the human body. Although BandWave™
contains only materials known to be biocompatible with the human body, it is still
62
advisable that animal studies be performed prior to human clinical trials, because
ensuring human safety and welfare is of utmost importance. Three tests will be
performed in this animal study: sensitivity, irritation and intracutaneous reactivity, and
acute systemic toxicity.
The objectives of each of these tests are described in detail in the following
sections. Cytotoxicity will not be performed in animal trials because an in vitro study is
sufficient to determine whether or not this device is toxic to cells.
Sensitization
Sensitization is an immune reaction of the body such as redness, irritation,
itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals
within the product in question. The objective of this sensitivity study is to determine
whether BandWave™ is an irritant to human skin.
Irritation and Intracutaneous Reactivity
Irritation in this context includes skin, eye, and mucosal irritation. ISO 10993
defines irritation as "localized inflammatory response to single, repeated, or continuous application of the test substance, without involvement of an immunological
mechanism." Chemicals within certain products can cause irritation of various tissues of the body. The purpose of this study is to demonstrate that the materials and chemicals
used in BandWave™ do not cause irritation of bodily tissues.
Acute Systemic Toxicity
Acute systemic toxicity is defined as any adverse effect occurring within a short
time after administering a dose of a particular substance (or an extract). This test is
required for all devices that make contact with blood. Since BandWave™ is designed to
be placed over an open wound, it will come into contact with blood, and therefore a test
for acute systemic toxicity should be performed. The objective of this study is to
demonstrate that no adverse systemic effects occur because of this product.
Materials
For all animal trials, BandWave™ will be made into an extract to concentrate the
chemicals found in the device. This extract will be used in each of the three studies to be
63
performed during the animal trials. ISO 1099312 details the procedure by which
extracts should be made for use in clinical studies. The device to be tested should be a
representative sample of a finished product, including any coatings, surface treatment,
sterilization, etc. that are performed on a product before it is sold. Two extracts will be
made: a physiological saline solution extract and a vegetable oil extract. These solvents
are recommended by ISO 1099312 because the saline solvent will create an extract from
the polar materials in the device, and the vegetable oil will create an extract from the
nonpolar materials in the device. Both of these solvents are harmless to cells.
The extraction ratio for each test will be determined from the same table as was
used in the in vitro studies. Extractions of highdensity polyethylene will be used as
negative controls, since this material is recommended in ISO 1099312 and has been
shown to have no toxic effects on cells or tissues.
Methods
1. Sensitization
Sensitization is an immune reaction of the body such as redness, irritation,
itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals
within the product in question. The objective of this sensitivity study is to determine
whether this BandWave™ is an irritant.
Guinea pigs will be used in this study because this species is nearly as responsive
to dermal sensitizers as humans are. A patch of fur on the guinea pig’s back will be
shaved off to make the skin more visible. The MagnusonKligman test method will be
used for this test (Medical Device and Diagnostic Industry). In this test, separate groups
of guinea pigs are given an injection of one of the extracts, along with an adjuvant,
which is intended to enhance the immune response to the extracts for maximum
sensitivity. After this, the guinea pigs receive a topical application of the extract. The
guinea pigs are given a twoweek period of recovery, and then are covered with a topical
patch containing the extract. After this, the animals are examined for patches of redness
or swelling that are not present in the negativecontrol animals.
2. Irritation and Intracutaneous Reactivity
The irritation/intracutaneous reactivity test will be conducted using two extracts
of the medical device described in the “Materials” section. One extract will be made in a
saline solvent and the other will be made in a vegetable oil solvent. The control materials
are pure saline and pure vegetable oil. In this study, a small volume of either the saline
64
or the oil extract will be injected intracutaneously into multiple different locations on
the shaved backs of albino rabbits via a sterilized smallbore needle. In addition, each
subject will also be given multiple intracutaneous injections of the control solution that
corresponds to whichever extract they were given.
At 24, 48, and 72 hours after the injection, the rabbit’s skin will be
assessed by a trained and blinded observer for signs of erythema and edema, and the
results will be scored based on severity of the irritation. Extracts that produce a
significantly greater irritation response in this test will be considered irritants (Medical
Device and Diagnostic Industry).
3. Acute Systemic Toxicity
Acute systemic toxicity refers to a shortterm exposure to the substance in
question. Shortterm exposure is considered to be a period of 72 hours for the sake of
this study. In this study, a group of mice will be given an injection of the extract and will
then be weighed. An equal number of mice will be used as a control group, and these
mice will be injected with the extraction solvent (either saline or vegetable oil) with no
device extract.
The mice are then observed for the next three days for signs of systemic toxicity
(convulsions, prostration, etc.) and these results are compared to the results in the
control mice to determine if there are any acute systemic toxic effects caused by this
device (Medical Device and Diagnostic Industry).
Human Clinical Trials Strategy
Summary
The first round of human clinical trials will be completed after in vitro testing has
been performed. Assuming the in vitro studies demonstrate biocompatibility and there
are no indications of cytotoxicity caused by the device extract, the human clinical trials
will proceed as detailed below. The purpose of the first round of human clinical trials is
to demonstrate that this device is biocompatible in humans. The clinical trials protocol
was based on the biocompatibility test matrix from ISO10993, shown below.
65
BandWave™ is a surface device that is applied to breached or compromised
surfaces with a limited (<24 hours) or prolonged (24 hours30 days) contact duration,
depending on the physician’s judgment. According to this matrix, the necessary
biocompatibility tests include cytotoxicity, sensitization, and irritation or intracutaneous
reactivity. The tests that are recommended include acute systemic toxicity and
subchronic toxicity. The acute systemic toxicity test will be performed. The subchronic
toxicity test will not be performed because the device does not contain any materials
that have ever been shown to cause either shortterm or longterm harm to the human
body, and the acute systemic toxicity test will sufficiently demonstrate the absence of
toxic effects on human tissue.
A second round of human clinical trials will be conducted to assess the
effectiveness of BandWave™ in wound healing and pain relief. Two trials will be
conducted. The first study will assess the efficacy of the TENS pain relief system. The
second study will assess the efficacy of the rapid wound healing therapy using the
microbattery array.
66
Board Approval
The FDA requires that Institutional Review Board (IRB) approval be
acquired before any clinical trials involving human subjects begins (21 CFR 812). An
IRB is defined as a group that has been designated to monitor and review research
involving human subjects with the purpose of protecting the rights and welfare of these
subjects. IRBs are required to register with the FDA before they can approve any clinical
studies, per 21 CFR 56.106. The role of the IRB is to review the clinical trial design, have
authority to approve or disapprove of the study, and require modifications if necessary.
Clinical Trials Protocol
This clinical trial will be conducted in accordance with Good Clinical Practice
(GCP) guidelines and the Code of Federal Regulations on the Protection of Human
Subjects (45 CFR 46). All personnel involved in the conduct of this study have
completed human subjects protection training. Informed consent will be obtained prior
to enrolling patients in the study.
There are three different tests that will be performed within this study with the
objective of assessing the biocompatibility of BandWave™. Each patient enrolled in this
study will be placed into one of these three categories and assessed for that specific form
of biocompatibility. The three categories are sensitivity, irritation or intracutaneous
reactivity, and acute systemic toxicity.
Cytotoxicity will not be performed on human subjects because an in vitro study is
sufficient to determine whether or not the device extract results in cytotoxicity.
The two tests that will be performed to determine the efficacy of this product are
pain relief assessment and rate of wound healing.
Safety/Biocompatibility Trial Design
Materials
For the sensitization test and the acute systemic toxicity test, the device itself will
be used as the only material. The device must be a representative sample of a finished
product, including any coatings, surface treatment, sterilization, etc. that are performed
67
on a product before it is sold. The use of the BandWave™ in this study is explained in
the methods section below.
For the other test, the device to be tested will be made into an extract to
concentrate the chemicals found in the device, and this extract will be used in the
irritation/intracutaneous reactivity study. ISO 1099312 details the procedure by which
extracts must be made for use in clinical studies. The device to be tested should be a
representative sample of a finished product, including any coatings, surface treatment,
sterilization, etc. that are performed on a product before it is sold. Two extracts will be
made: a physiological saline solution extract, and a vegetable oil extract. These solvents
are recommended by ISO 1099312 because the saline solvent will create an extract from
the polar materials in the device, and the vegetable oil will create an extract from the
nonpolar materials in the device. Both of these solvents are harmless to cells.
The extraction ratio for each test will be determined from the same table as was
used in the in vitro studies. Extractions of highdensity polyethylene will be used as
negative controls, since this material is recommended in ISO 1099312 and has been
shown to have no toxic effects on cells or tissues.
Methods
1. Sensitization
Sensitization is an immune reaction of the body such as redness, irritation,
itchiness, or swelling that is caused by repeated or prolonged exposure to the chemicals
within the product in question. The objective of this sensitivity study is to determine
whether this BandWave™ is an irritant to human skin. This device will be used
externally and so testing will be performed on both healthy, unbroken skin and open
wounds.
To test BandWave™ on healthy, unbroken skin, first, a small patch of skin on the
patient’s arm or leg will be shaved to expose a greater surface area of tissue. The patch
that is shaved will be the same size as the smallest size bandage that can be cut from the
BandWave™™. A second small patch 12 inches away from the first site will also be
shaved. This will be used as a control site. The BandWave™ will be cut to size with a
clean, sterilized pair of stainless steel or surgical scissors, so as to prevent
contamination. The bandage will be applied to the shaved patch of skin by a trained
68
nurse wearing hypoallergenic (nitrile) gloves, and the bandage will remain on the
patient’s skin for 23 hours (plus or minus 1 hour daily) for 21 days consecutively. Each
time the bandage is removed (once per day), the skin should be evaluated for signs of a
reaction (redness, swelling, irritation, etc.). If a serious reaction occurs, the bandage
should be removed completely and the patient should be released from the study. The
daily evaluation should be performed by a trained and blinded observer, using the
following scale as an evaluation guide:
0 negligible sensitivity (e.g. clear skin, no redness, swelling or irritation)
1 slight sensitivity (e.g. light red/pinkish color, or light swelling)
2 moderate sensitivity (e.g. some signs of irritation, moderate redness, moderate
swelling)
3 severe sensitivity (e.g. heavily irritated skin, lots of redness, heavy swelling)
These results will be recorded by the observer and the results will later be
analyzed.
2. Irritation and Intracutaneous Reactivity
The irritation/intracutaneous reactivity test will be conducted using two
extracts of the medical device described in the “Materials” section. One extract will be
made in a saline solvent and the other will be made in a vegetable oil solvent. The
control materials are pure saline and pure vegetable oil. In this study, 0.2mL of either
the saline or the oil extract will be injected intracutaneously into two different locations
on the forearm of each subject via a sterilized syringe. In addition, each subject will also
be given two 0.2mL intracutaneous injection of the control solution that corresponds to
whichever extract they were given. Each injection will be at least 1 inch away from all
other injection sites.
At 24, 48, and 72 hours after the injection, each subject’s skin will be
assessed by a trained and blinded observer for signs of erythema (redness) and edema
(swelling). The results will be scored based on a similar scale as described in the
sensitization test. Extracts that produce a significantly greater irritation response in this
test will be considered irritants.
3. Acute Systemic Toxicity
69
Acute systemic toxicity refers to a shortterm exposure to the substance in
question. Shortterm exposure is considered to be a period of 72 hours for the sake of
this study. In this study, acute systemic toxicity will be assessed by using the whole
bandage rather than an extract.
Each patient will be given a small cut, 0.5 inch in length, with a sterilized scalpel
on one of their legs, and the bandage will be placed over the cut. The bandage will be
activated electrically to simulate actual intended use. The bandage will be left in place
for 72 hours, with a brief removal occurring once every 24 hours in order to clean the
wound. During the period of 72 hours each patient will be assessed for any adverse
systemic events, and every adverse systemic event will be recorded by a trained
observer. These results will be compared to a hypothetical control of no adverse events.
After the period of 72 hours, the bandage will be removed and the wound will be
cleaned. The patient will be monitored for another 48 hours after removal of the
bandage, and after these 48 hours the patient will be released from the study.
Efficacy Trial Design
Materials
In the efficacy trials, the BandWave™ itself will be used. The bandage must be a
representative sample of a finished product, including any coatings, surface treatment,
sterilization, etc. that are performed on a product before it is sold. The use of the
BandWave™ in this study is explained in the methods section below.
Methods
1. TENS Efficacy
In this study, the efficacy of the TENS pain management unit will be assessed. This
study will be randomized and blinded. Patients with chronic wounds such as diabetes
ulcers will be recruited for this study. Patients will be randomly assigned to either the
test group or the control group. Those in the control group will not be given any pain
relief medication or cream for their wounds, but the wound will be covered with a
normal hospital bandage. The other wound will be covered with BandWave™ and the
TENS unit will be turned on to start the pain relief therapy. The patient will be asked to
rank their pain on a scale of 1 to 10 every two hours for the next 72 hours.
70
2. Microbattery Array Efficacy
In this study, the efficacy of the microbattery array on the bandage will be
assessed. This study will be randomized and blinded. This study will occur
simultaneously with the TENS efficacy test, and it will be performed on the same
patients in order to cut down on clinical trial costs. The wounds in the control patients
will not be given any pain relief medication or cream, but it will be covered with a
normal hospital bandage. The other cut will be covered with BandWave™. If there is no
moisture or bodily fluids on or near the cut, a few drops of water will be applied to
ensure that the microbattery array will be activated. Every 12 hours, the two bandages
will be removed and the length of the cut will be measured and recorded. This trial will
continue until either all the wounds have fully healed, or until 120 hours have passed,
whichever occurs first.
Patient Eligibility Criteria
Sample Size
In a surgical wound healing study done at Ohio State University by Ronald Glaser
et al. (L. McGuire, K. Heffner, R. Glaser source), patients with surgical wounds rated their pain on a scale of 110. From the figure above, the median amount of time it took for
patients to rate their pain as 4 or lower was approximately 21 days. Based on this data, it
is estimated that BandWave™ can heal wounds 45.4% faster. However, to be on the
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conservative side for clinical study purposes, an expected rate of 10% faster healing will
be used to calculate the sample size. The following equation is used, where N = total
number of subjects required, zα = standard normal deviate for α, zβ = standard normal
deviate for , S = standard deviation of the outcome variable, E = expected effect size.
10% of 21 days = 2.1 days
S = estimated to be approximately 10 days
Data Management
All data will be collected using the software, Oracle Clinical. A Case Report Form
is first designed to translate protocolspecific activities into data being generated. Then
a Data Management Plan is developed based on database design, data entry,
discrepancy management and database locking guidelines along with a Data Validation
Plan containing editchecks to be performed and identifying discrepancies. Oracle
Clinical contains “system validation” which includes data security, user requirements,
regulatory compliance, objectives, intervals, visits, investigators and patients. The
investigator collects data into the system with an eCRF method to prevent errors and
faster resolution of discrepancies. Any entries made in the CRF will be monitored by the
Clinical Research Associate to track any missing or illegible data or clarification. Edit
check programs are written to validate the data and identify discrepancies in the entered
data that are initially tested with dummy data containing discrepancies to ensure
effectiveness. Discrepancies are defined as any inconsistent data, missing data,
deviations from protocol, etc. and are run frequently and at regular intervals.
Discrepancy management is resolved by the investigator and includes reviewing
discrepancies, investigating the reason and resolving them with documentation. After
quality checks, the final data is run for validation. If there are no discrepancies, the data
is finalized in consultation with the statistician. Once approval is obtained, the database
is locked followed by archival.
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Ethical Considerations
The degree of all risks and benefits associated with BandWave™ are evaluated to
maximize benefits while minimizing risk to determine a favorable ratio for each
individual patient. Before clinical trials, an Institutional Review Board, in accordance
with the Food and Drug Administration/Investigational Device Exemption, reviews the
proposal to confirm an ethically designed trial while also monitoring the study while it is
ongoing. All individuals taking part in the trial undergo an informed consent process
where they are accurately informed of the purpose, risks, benefits, methods, etc. of the
trial, understand the information of BandWave™ and how it relates to their personal
clinical situation, make a voluntary decision about participating and then provide a
written form of consent. Individuals’ information and privacy are kept confidential and
are notified of any new information on the trial. The individual's’ welfare is monitored
throughout the study.
Subject Recruitment
Subjects used for this trial are individuals from all demographic backgrounds. We
will be recruiting patients, who currently suffer from chronic wound, of all ages,
ethnicities, sexes, and medical backgrounds since wounds and wound healing affects all
individuals. Patients will be pulled by way of their physicians (preferably the principal
investigator) and recruitment will be aided by inpractice recruiting tools and by paper
or EMR chart reviews. Patients with more minor wounds not requiring medical
attention will also be recruited from television advertisements, social media, billboards,
radio advertisements, email targeting and also outside services such as patient networks
and patient recruitment companies.
Investigator Recruitment
The principal investigator will be recruited by submitting the clinical trial
proposal on websites such as CenterWatch.com and ClinicalTrials.gov. Online databases
of potential investigators, such as CROs including PPD, will also be a useful tool in
finding a principal investigator. Advertising, personal contact and networking are also
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possible avenues. The principal investigator will be chosen based on knowledge and
interest in wounds and wound healing.
Site of Trials
The site of clinical trials will be chosen based on special populations more at risk
for wounds and where these populations are concentrated. These populations include
bariatric patients, ICU patients, HIV and AIDS patients and geriatric patients. Since a
portion of the trial and targeted market will be patients with surgical wounds, we will
select the Los Angeles Surgical Center. Los Angeles is one of the most diverse cities in
the nation in terms of age, gender and race so we will be able to acquire surgical patients
from all backgrounds in Los Angeles, while also being accessible for individuals from all
socioeconomic backgrounds for nonsurgical wounds.
Executive Summary: Finances and Reimbursement
After analyzing the market for the BandWave™, Voltaic Solution has identified that the BandWave™ has the ability to positively affect a projected population of nearly 60,000,000 people. This estimation includes postoperative patients, the growing elderly population, and those with chronic diseases that cause epithelial wounds. With such a large market, Voltaic Solutions will slowly ease into the market by supplying first to hospitals, followed by the general consumer population in future years. In order to begin production of the BandWave™, Voltaic Solutions will require an investment of $18,392,320 to cover the costs of clinical trials, manufacturing expenses of 1,000,000 units from overseas production near the Zhangjiang HiTech Park facility in Shanghai, China, shipping costs in order to deliver the product to the storage and distribution site in Los Angeles, California, and marketing. The cost to produce one unit of the BandWave™ is $17.01. The outsourced manufacturing and shipping costs will increase the price of each BandWave™ unit to $18.10. In order to incentivize hospitals to buy the BandWave™, we will offer a 15% bulkdiscount from the consumerbased selling price of $30. The selling price of the BandWave™ will be $25.50 for hospitals and $30 for consumers. Given the 121 hospitals in Greater Los Angeles, Voltaic Solutions will evenly distribute the 1,000,000 units to these hospitals, ensuring that each of these hospitals buys 8,264 units of the BandWave™, thus generating $25,498,572 in revenue. After
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subtracting the costs of the $18,392,320 from the initial investment, the total profit is projected to be $7,106,252. This is only the beginning of the BandWave™’s projected expansion into the second year. In the second year, BandWave™ will increase production to 1,500,000 units in order to accommodate increased sales in the Los Angeles area. The increase in sales will cause expenses to increase to $27,148,297 due to increased production and expenses that go along with an increased amount of units. Sales are projected to continue increasing given that Voltaic Solutions has barely tapped into the projected consumer base. We will now assume that each of the 121 hospitals in Greater Los Angeles buys 10,505 units, and that each of the 83 closest Nursing Homes stores each buy 2,673 units. Expenses in the second year will be $27,148,297, and Voltaic Solution anticipates that every BandWave™ will be sold in order to generate a revenue of $39,068,948 . The resulting net profit after expenses are subtracted from the revenue is $11,920,651. The combined year 1 and year 2 profits is $19,026,903. Voltaic Solutions will continue expansion into the third year to hospitals throughout California, as well as continued sales at the 83 Nursing Homes locations. After increasing production to 2,000,000 units per year, the expenses for the third year are estimated at $36,190,240. Voltaic Solutions will continue to sell 2,673 units to each of the 83 Nursing Homes stores, 10,505 units to the 121 Los Angeles Hospitals, but will sell the remaining 500,000 units to various hospitals throughout California. Assuming that all of the BandWave™ units are sold, the net profits from the third year will be $15,628,708. The profit from the first three years combined will total $34,655,610. After the third year, Voltaic Solutions will face the decision of whether to seek a buyout from a large corporation, or to grow from a small business model into a larger business or corporation. From a cost analysis and projected growth standpoint, Voltaic Solutions will partner will seek to partner with Johnson & Johnson. This merge will benefit both Voltaic Solutions and Johnson & Johnson given that Voltaic Solutions will now be capable of tapping into a larger consumer base in order to better affect positive change while helping Johnson & Johnson to address their need for innovation and advanced products. Market Size Analysis
Market Size Estimate
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Total Number of All U.S. Registered Hospitals 5,686
Surgeries per year in U.S. +50,000,000
Surgeries without incisions/year 10,000,000
Elderly people who fall/year +20,000,000
Potential BandWave™ Consumer Base 60,000,000
From our analysis, we have determined that the market for the BandWave™ is very large and promising. Based on our estimates from researching the current situation, we believe that the BandWave™ could positively benefit nearly 60 million people in just the United States alone. Because of the novelty, convenience, and reasonable price of the BandWave™, there is not currently any competition on the current market. However, although Voltaic Solutions estimates a market of 60,000,000 potential customers, we find it unlikely that this projection will be achieved for various reasons. With standard healing applications, such as bandage protection, it will be essential to market the product in such a way that consumers see the benefits of the product. Additionally, because of the reimbursement codes, hospitals and patients should not need to experience the majority of the additional cost. Based on the 60,000,000 market estimate, we will predict that 25% of this estimate will be reached within the first year, and will continue to rise by 10% each additional year following. However, as mentioned previously, given that Voltaic Solutions will run as a small business initially, we will produce and plan to sell 1,000,000 units in the first year. Because Voltaic will preliminary limit sales to the Los Angeles area, the target audience will be both hospitals and Nursing Homes. In addition to the number of invasive surgeries increases, leaving patients with open wounds in need of healing, Voltaic Solutions also seeks to address the needs of a growing elderly population. In the Los Angeles area alone, the United States Census Bureau reports an elderly population of 1,684,181 people over the age of 65. Additionally, there are 83 Nursing Homes in Los Angeles, thus creating a growing target population of elderly citizens seeking a faster and less painful recovery period.
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Financial Analysis Assumptions In order for to analyze the costs and profitability of selling the BandWave™, it was necessary to make several assumptions. First, the cost analysis of manufacturing the BandWave™ excludes tax and inflation. The figures we are using are current prices and estimated prices for buying in bulk. Because the inclusion of tax and inflation would significantly complicate the financial analysis, we chose to exclude them. Our main customers for the BandWave™ will be both hospitals and civilians seeking to reduce the healing time of their wound. As can be seen below, the estimated cost to produce one unit, including shipping and storage costs, is $18.10. This was determined through a cost analysis of the necessary materials as well as the manufacturing process. All proposed sales and profit forecasts are conducted under the assumption that Voltaic Solutions will be run as a small business. This allows for a lower number of manufacturing costs for the initial products and lower expenses for utility, storage, and shipping costs to reduce risks. Financing We expect that a significant amount of our startup capital will come from loans, and a small percentage from investors. The financing plan includes the creation of brochures to advertise the revolutionary healing process that the BandWave™ will initiate, as well as a profit projection and design plan in order to entice investors to provide startup capital to fund our clinical trials and regulatory costs. These will be the same brochures that we will provide to hospitals to convince them of the profitability of our product. Given that Voltaic Solutions will not be expanding beyond California until at least year four, we will be dedicated towards selectively branding the BandWave™ in order to excite the rest of the market for our expansion. Our technology and marketing will demonstrate that the BandWave™ is a safe investment and will generate a high return on an investment. Additionally, hospitals will be incentivized to order the BandWave™ in bulk in that Voltaic Solutions will offer a bulk discount of 15% off of the regular unit selling price of $30 so hospitals will only be paying $25.50 per unit. Production, Distribution, and Profits The first year of business:
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For the first year that BandWave™ is on the market, 1,000,000 units will be manufactured. The product will be manufactured at a manufacturing company in Shanghai, China, and shipped to the Port of Long Beach, California, where it will then be transported by ground to the USC area. The product will then be stored until distribution is necessary. The total cost to manufacture the BandWave™ was calculated by multiplying the 1,000,000 units by the approximate cost per unit of $17.01. To cargo ship all 1,000,000 units across the ocean, we estimate that the entire order will fit into 200 pallets. A standardized pallet is 48 inches by 40 inches, and capable of holding 5,000 pounds [US Plastics]. Given that each BandWave™ unit is 1 pound, this will allow 1,000,000 units to be shipped in 200 pallets. According to an estimate by XpressRate.com, shipping 25 “full container loads,” 200 pallets, will cost $53,250. The total shipment cost is $53,250 from Shanghai, China to Long Beach, CA. (XpressRate) From Long Beach, the product cargo will be delivered to the USC area. From freightcenter.com, the ground transport will cost $22,750 for 200 pallets. The truck will start from the docks of Long Beach and unload the product at the storage site near USC. For storage, Voltaic Solutions will use Public Storage because of the valued prices and numerous locations across the country. The small business storage is an effective starting point for distribution. For the largest unit available, the rate is $310 per month for a 10 foot by 20 foot storage space. For the second and third year of business, with an estimated increase in production by 500,000 units per year, this increase in pallets would result in the necessity of two large storage units. Based on these figures, the first year of storage would cost $3,720, and the second and third year would cost $7,440. (PublicStorage) For marketing and distribution of the BandWave™, Voltaic Solutions will have a sales team. The sales team will have an annual budget of $3,000 to go towards marketing materials. For the first year of business, the sales team will go out and market to the 121 hospitals in the Los Angeles metropolitan area while supplying to the hospitals. Estimating gas prices at $4.50 per gallon, Voltaic Solutions estimates 150 gallons of gas per month, thus costing $8,100 for the year. The following table shows the cost of production for the BandWave™ as well as shipping, storage, and marketing costs. The cost of clinical trials has been added to the preliminary investment in year 1, but does not affect yearly expenses thereafter. Additionally, a more detailed cost estimate of clinical trials can be found below. The total expense for production and transportation of one unit is $18.10 based on the
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estimates. The price was estimated with the knowledge that the materials would be purchased and the units manufactured in bulk.
Item Cost Per Unit
USA Tyco Adhesive Gel
coated 2 carbon electrodes $2.16
Microbattery Array 3x12cm $7.50
Medical Gauze 5x16cm $0.45
ETS Fabric $0.65
PCB board $5.00
Adhesive Film 18x15cm $0.50
Components for PCB Board $0.50
LED Light $0.25
Total Costs $17.01
Clinical Trials
Study Categor
y Cost
Irritation Animal $1,800
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Sensitization Animal $6,000
Acute Systemic Toxicity Animal $900
All safety tests Human $182,00
0
All efficacy tests Human $100,000
Cytotoxicity In vitro $800
Tota $291,50
0
Storage, Distribution, and Marketing Costs
Year 1 Year 2 Year 3
Clinical Trials $291,500 0 0
Units Produced 1,000,000 1,500,000 2,000,000
Cost to produce $17,010,00
0 $25,515,00
0 $34,020,00
0
Transoceanic Shipping of 4 Pallets (China to
California) $53,250 $82,282 $106,500
Ground Transport $22,750 $34,125 $45,500
Storage $3,720 $7,440 $7,440
Distribution $8,100 $9,450 $10,800
Marketing $3,000 $3,000 $3,000
Total $18,392,32
0 $27,148,29
7 $36,190,24
0
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Cost per Unit 18.10 18.10 18.10
Profit Forecast for Three Years In order for the BandWave™ to become profitable in Year 1, it must meet the first year expense of $18,392,320. At the hospital discount price of $21.25 it would require BandWave™ to sell 721,268 units in order to begin generating a profit. The following table shows the total profit for the first year of business at the $21.25 selling price for hospitals. This figure indicated that we have not yet reached out to the retail consumer market.
Number of Units Sold
Total Profit in USD
0 $18,392,320
100,000 $15,842,320
300,000 $10,742,320
400,000 $8,192,320
500,000 $5,642,320
600,000 $3,092,320
700,000 $542,320
800,000 $2,007,680
900,000 $4,557,680
1,000,000 $7,107,680
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Because the goal of Voltaic Solutions is to begin marketing to hospitals, the first year business plan of advertising will be dedicated towards hospitals in the Los Angeles area. This will allow the BandWave™ to revolutionize the healing process of patients who are recovering from surgery, and elderly patients who have suffered a fall.
Year One Number of Places
Number of Sold Units
Price per Unit Profit
Hospitals 121 8,264 $25.50 $25,498,572
Nursing Homes 0 0 0 $0
Revenue $25,498,572
Expenses $18,392,320
Total $7,106,252
In the second year of production, Voltaic Solutions plans to expand its market beyond hospitals in the Los Angeles area to include the average American consumer as well. In addition to the postop surgical application of BandWave™, the device may also be used to speed wound healing of everyday cuts and scrapes in addition to alleviating pain.
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Thus, BandWave™ will be distributed to Nursing Homes in the Los Angeles area to provide accessibility to a wider range of consumers. As the market size increases, so does the yearly net profit. After year two, we see an increase in profit from $7,106,252 to $11,920,651, indicating 67.75% projected increase in net profit.
Year Two Number of Places
Number of Sold Units to each
location
Price per Unit Profit
Hospitals 121 10,505 $25.50 $32,413,178
Nursing Homes 83 2673 $30 $6,655,770
Revenue $39,068,948
Expenses $27,148,297
Total $11,920,651
BandWave™ will continue to increase its presence as a viable wound healing and pain relieving solution into its third year of production. Its original market will be expanded from the Los Angeles area to include the entire state of California. The net profit will increase from the second year yield of $11,920,651 to $15,628,708. This indicates an increase in net revenue of 32% from year two to year three.
Year Three Number of Places
Number of Sold Units
Price per Unit Profit
Hospitals 121 10,505 $25.50 $32,413,178
Nursing Homes 83 2673 $30 $6,655,770
Other Hospitals tbd 500,000 $25.50 $12,750,000
Revenue $51,818,948
Expenses $36,190,240
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Total $15,628,708
Future As Voltaic Solution continues to expand and tap into the expected market of 60,000,000 potential patients, our small business will hope to transition into a larger business by year three. Moving from a storagebased distribution, Voltaic Solutions hopes to buy a functional office location to house employees, manage distribution, and continue marketing and sales. Additionally, Voltaic Solutions will tap into new markets throughout the country and continue to revolutionize the healing process. Along the way, Voltaic Solutions will continue to refine the BandWave™ in order to meet customer needs and satisfaction, and experiment with new components of the product in order to minimize price and make the BandWave™ as accessible to consumers as possible. Feasibility The revolutionary technology of the BandWave™ will capture the attention of millions of patients seeking to quicken their recovery process while simultaneously minimizing pain in the process. Instead of using the standard bandage on a wound and applying inconvenient gels or creams to the affected wound, the BandWave™’s dual technology will address both pain management and recovery time. While this product can positively affect any person with a recovering wound, Voltaic Solutions will primarily focus on the Los Angeles area in order to mitigate costs of reaching out to a large market before we have the capacity to do so. By selectively having presence in a select market, word of mouth and advertising will spread the word of the BandWave™ before we are able to expand. Continuing into the second year, Voltaic Solutions is working to expand presence to a greater extent in the Los Angeles Area by reaching out to Nursing Homes throughout Los Angeles. While expansion into the Nursing Home market is taking place, the sales team will simultaneously be preparing to spread across California in the upcoming year. Profits made during the first and second year will be allocated towards increased advertising and salespeople. It is essential to be forward thinking and to continue working towards growth areas and expansion.
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As Voltaic Solutions enters into the third year of sales, the BandWave™ will begin entering markets throughout the state of California. It is at this point that Voltaic Solutions will establish whether to continue expansion throughout the country, and perhaps internationally, or pursue getting bought out by a larger corporation. Additionally, we will heavily considering relocating to an office location and develop capabilities of production, storage, and distribution instead of outsourcing production overseas and incurring unnecessary expenses. However, throughout these years and continuing on into the future, Voltaic Solutions will make necessary alterations along the way in regards to business practices, BandWave™related production, and any other necessary means to increase customer satisfaction. The BandWave™ has the potential to revolutionize the healing process as we know it, and our mission is to affect the most amount of change as possible, in an affordable and customerfriendly way. Reimbursement Strategy In the consideration of reimbursement strategies for our product, we considered both public and private payers. In terms of public payers, we will focus on Medicare and Medicaid, both falling under the Centers for Medicare and Medicaid Services, which is a federal agency. Medicare is an entitlement run by the government to provide health insurance to beneficiaries either 65 years of age and older, to people of all ages with certain disabilities, and to people with EndStage Renal Disease. Medicaid is a program based on financial eligibility rather than age, and serves lowincome American families. While private payers make up the majority of medical reimbursements, there are many more variables and minutia to take into consideration when providing reimbursement via this route given that there not a uniform standard. The BandWave™ by Voltaic Solutions is a device that is not limited to certain ages, and can be considered for reimbursement by Medicare, Medicaid, and private means. The BandWave™ will be readily available to both hospitals and to those wishing to benefit from the novel technology. (Centers for Medicare and Medicaid Services) Reimbursement Coding Regardless of whether the insurance provider is public or private, the appropriate code must be submitted in order for a medical center to get reimbursed. This method of coding serves to simplify the billing procedure, allowing the code to be analyzed as the
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language that describes a medical encounter and dictates the billing procedure. The three types of reimbursement codes include Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), and International Classification of Diseases (ICD). The CPT coding system describes how to report procedures or services. HCPCS codes are used to identify physician procedures, devices, supplies, and drugs. The ICD9CM is a system of codes used by healthcare professionals to report diagnoses and disorders, but are often not accepted for billing purposes by third party payers. (U.S. Food and Drug Administration) The majority of HCPCS services are not included in CPT codes, such as ambulance services, drugs, and durable medical equipment when used outside of a physician’s office. The federal government frames and maintains these codes, which have become mandatory for transactions involving health care since 1996 when the Health Insurance Portability and Accountability Act (HIPAA) was passed. HCPCS may also give temporary codes for new technologies and services, given that the applications for new codes are effective the following year. Level 1 of HCPCS coding is comprised of CPT, a numeric coding system maintained by the American Medical Association. Level II consists of a standardized coding system to identify services that are not included by the CPT, and consist of a single letter followed by 4 numeric digits. Level III codes, originally referred to as local codes, were eliminated by HIPPA. The BandWave™ will use three preexisting HCPCS codes for reimbursement: A4558, A4630, E0720.
HCPCS Code
Category Descriptor
A4558 Conductive gel or paste, for use with electrical device (e. G. , tens, nmes),
A4630 Replacement batteries, medical necessary, transcutaneous electrical stimulator, owned by patient
E0720 Transcutaneous electrical nerve stimulation (tens) device, two lead, localized
We will not be required to apply for new codes, and will instead use existing ones. However, it may be necessary that we apply for a minor modification of code E0720 for
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the TENS device due to the fact that Voltaic Solutions will be producing its own version of the TENS device into a more accessible unit. We are not changing anything about the existing product that would affect the reimbursement procedures. Instead, we are using existing technology, TENS, coupled with electric field wound healing in order to reduce pain simultaneously with the recovery period.
HCPCS Code
Status Reimbursement
A4558 New Purchase $6.05
A4630 New Purchase $5.89
E0720 New Purchase $346
Additionally, the International Classification of Diseases (ICD) is managed by the World Health Organization, and is unique internationally. These codes are diagnosis based, and serve to identify the reason for the exam and describe the medical necessity. The ICD9 will transition to a new, longer coding system ICD10 in October of 2015. The current ICD9 codes that match with the BandWave™ are as follows: 874.8 Open wound of other and unspecified parts of neck without complication 875.0 Open wound of chest without complication 876.0 Open wound of back without complication 877.0 Open wound of buttock without complication 879.2 Open wound of abdominal wall anterior without complication 879.4 Open wound of abdominal wall lateral without complication 897.6 Open wound of other and unspecified parts of trunk without complication 879.8 Open wound of unspecified site without complication 880.09 Open wound of multiple sites of shoulder and upper arm without
complication 881.0 Open wound of forearm without complication 884.0 Multiple and unspecified wound of upper limb without complication 890.0 Open wound of hip and thigh without complication 894.0 Multiple and unspecified open wound of lower limb without complication
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In order for a hospital to get reimbursed, they must provide both the diagnosis (ICD9 diagnosis codes) and device codes (HCPCS codes), while third party payers may only be responsible for the HCPCS code. (Centers for Medicare and Medicaid Services) National and Local Coverage In the United States, Health Insurance coverage is classified into either federal governmentbased and state governmentbased insurance called either national or local coverage policies. National coverage policies account for nearly 10% of all coverage determinations, while local coverage policies account for the remaining 90%. National coverage will always supersede local coverage, and local coverage policy may expand national coverage, unless national policy is exclusionary. Medicare and Medicaid fall under federalgovernment based insurance. Given that the BandWave™ technology utilizes the existing TENS technology, we will plan to use the similar reimbursement codes. Medicare Part B pays 80 percent of the Medicareapproved amount for the purchase of a covered TENS device with certain medical cases. (Noridian Healthcare Solutions) Private Coverage Private insurance companies are the biggest contributors to health insurance coverage in the United States. It is important to obtain their coverage for the success of Voltain Solution’s BandWave™. Different companies use different reimbursement rates, and some of the largest private health insurance companies include Aetna, Blue Cross, and Blue Shield Association. Feasibility
By assessing the feasibility of Voltaic Solution’s BandWave™, the manufacturing costs in combination with the current market needs indicate that the BandWave™ is not a feasible product. While the projected market predicts a large enough consumer base with a large potential profit, the existing bandages on the market have potential to prevent hospitals from deeming it worthwhile to spend the additional money on the BandWave™. The more expensive price tag associated with the innovative technology that the BandWave™ offers may cause Medicare and Medicaid to deem the cost an unnecessary expenditure. The cost of production and initial marketing of the
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BandWave™ would require considerable capital, which our company believes is not realistic. Voltaic Solutions is a revolutionary company that strives to make excellent devices, but unfortunately BandWave™ would require too much money to be a feasible and profitable device. Furthermore, the reimbursement codes we are claiming for our product are not guaranteed, which leaves the company at risk of not obtaining reimbursement. This report allowed us to understand the scope of what is required to develop a medical device and has allowed us to distinguish our product as an unfeasible device with no future for production. Contribution Design, Technology and Safety Issues Desmond Dizon, Maksym Tsvetkov, Douglas Yuk Market Requirements and Reimbursement Strategy Regulatory and Clinical Trials Strategy References
XpressRate.com
PublicStorage.com
freightecenter.com
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTob
acco/CDRH/CDRHTransparency/ucm203018.htm
https://www.dmepdac.com/index.html
http://www.lni.wa.gov/claimsins/files/providerpay/feeschedules/2012fs/fshcpcs
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https://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/icd10/01_
overview.asp
http://www.healthcare.philips.com/main/products/mother_and_child_care/po
st_natal_care/well_baby/monitoring/smarttrace/
http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?sr
c=bkmk
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/
GeneralandSpecialControls/ucm055910.htm
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