Panel Session 8: Moving from Idea to Product · Panel Session 8: Moving from Idea to Product . Eric R. Sokol, Chair . Faculty: Kristin Johnson, Miles Rosen, Peter L. Rosenblatt .

Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Panel Session 8: Moving from Idea to Product

PROGRAM CHAIR

Eric R. Sokol, MD

Kristin Johnson, BSME, MS, Mat Sc Miles Rosen, MS Peter L. Rosenblatt, MD

Professional Education Information Target Audience This educational activity is developed to meet the needs of surgical gynecologists in practice and in training, as well as other healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 2 Needs Statement Generation and Needs Scoping E.R. Sokol ....................................................................................................................................................... 4

Stakeholder Analysis and Cycle of Care M. Rosen ...................................................................................................................................................... 7 Intellectual Property P.L. Rosenblatt ............................................................................................................................................. 9 Prototyping, Business Models, and How to Pitch K. Johnson ................................................................................................................................................... 11 Cultural and Linguistics Competency ......................................................................................................... 13

Panel Session 8: Moving from Idea to Product

Eric R. Sokol, Chair Faculty: Kristin Johnson, Miles Rosen, Peter L. Rosenblatt

This session will provide a forum to discuss the process of medtech innovation (how to invent a solution

for an unmet healthcare need), with particular emphasis on the Biodesign process developed at

Stanford University. We will cover topics central to the Biodesign process including (but not limited to)

needs identification, needs scoping, intellectual property, stakeholder analysis, brainstorming,

regulatory pathways, prototyping, business model generation, and how to pitch. This session will

present a broad overview and will provide a clear illustration of the overall process of bringing an idea to

market.

Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Describe the main

steps in the Biodesign innovation process that can be used as a framework for taking an idea for an

unmet healthcare need, and developing that idea into a solution that is viable in the marketplace.

Course Outline

3:25 Welcome, Introductions and Course Overview E.R. Sokol

3:30 Needs Statement Generation and Needs Scoping E.R. Sokol

3:40 Stakeholder Analysis and Cycle of Care M. Rosen

3:50 Intellectual Property P.L. Rosenblatt

4:00 Prototyping, Business Models, and How to Pitch K. Johnson

4:10 Panel Discussion All Faculty

5:05 Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* R. Edward Betcher* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Sarah L. Cohen Consultant: Olympus Erica Dun* Joseph (Jay) L. Hudgens Contracted Research: Gynesonics Frank D. Loffer, Medical Director, AAGL* Suketu Mansuria Speakers Bureau: Covidien Linda Michels, Executive Director, AAGL* Eric R. Sokol Stock Ownership: Pelvalon Contracted Research: American Medical Systems Karen C. Wang* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Sawsan As-Sanie Consultant: Myriad Genetics Lab Jubilee Brown* Aarathi Cholkeri-Singh Consultant: Smith & Nephew Endoscopy Speakers Bureau: Bayer Healthcare Corp., DySIS Medical, Hologic Other: Advisory Board: Bayer Healthcare Corp., Hologic Jon I. Einarsson* Suketu Mansuria Speakers Bureau: Covidien Andrew I. Sokol* Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Stock Ownership: Titan Medical Karen C. Wang* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Kristin Johnson* Miles Rosen Stock Ownership: Pelvalon Peter L. Rosenblatt Consultant: American Medical Systems, Boston Scientific Corp Inc., Coloplast, Covidien, Medtronic Contracted Research: Boston Scientific Corp. Inc., Coloplast Royalty: American Medical Systems, Cook Medical, UpToDate Stock Ownership: Pelvalon, Solace

2

Eric R. Sokol Stock Ownership: Pelvalon Contracted Research: American Medical Systems Content Reviewer has no relationships. Asterisk (*) denotes no financial relationships to disclose.

3

1

Need Statements, Scoping, and Need Criteria

Eric R. Sokol, MDAssociate Professor of Obstetrics and Gynecology

Associate Professor of Urology, by CourtesyCo‐Chief, Urogynecology and Pelvic Reconstructive Surgery

Stanford University School of MedicineBiodesign Faculty Fellow

Disclosure• Stock Ownership: Pelvalon

• Contracted Research: American Medical Systems

2

ObjectiveDiscuss needs statement, scoping, and key criteria.

3

Observation Can Lead to Many Needs

4

Observation

Need

Need

Need

Need

Need

Need

NeedNeed

Need

Needs Statement - Essential Ingredients

1. PROBLEM

2. POPULATION

3. OUTCOME

A way to address (PROBLEM) for (POPULATION) in order to improve (OUTCOME)

Example:

“A way to correct apical prolapse in symptomatic women in order to improve quality of life without invasive surgery.”

5

Objective Outcomes

6

Desired Outcomes As Measured By…

Improved clinical efficacy Treatment success rates in clinical trials

Increased patient safety Rate of adverse events in clinical trials

Reduced cost Total cost of procedure relative to available alternatives

Improved physician/facility productivity

Time and resources required to perform procedure

Improved physician ease of use Solution of complex workarounds and/or the simplification of workflow

Improved patient convenience Frequency and occurrence of required treatment, change in treatment venue (inpatient versus outpatient, physician’s office versus home), etc.

Accelerated patient recovery Length of hospital stay, recovery period, and/or days out of work

4

2

Writing A Need Statement• Isolate the single need that has the best chance of addressing the problem, driving a desired outcome, and supporting a reasonable market opportunity

• Capture need in one sentence statement

• Focus on the goal, not the problem

• Avoid solutions

• Get specific

• Change venue

• Stay positive

• Do it twice (scoping)

• Explore pathophysiology7

Common Pitfalls• Embedding a solution within the need

• Inappropriate definition of the scope

– Too broad

– Too narrow

• Avoid solutions

8

Needs statement scoping

• A way to correct pelvic organ prolapse in women in a clinic setting to reduce the need for surgery

• A way to correct vaginal prolapse in women with bothersome prolapse without incisions to reduce dyspareunia

• A way to correct uterovaginal prolapse in women with bothersome uterine prolapse to eliminate the need for hysterectomy

• A way to repair levator ani muscle damage in women who have sustained levator muscle injury from vaginal childbirth to reduce pelvic floor disorders

• A way to prevent levator muscle injury in women undergoing vaginal childbirth to prevent pelvic floor disorders

Need CriteriaGet into the weeds

10

Need criteria are the key elements required and/or desired by the customer

Zenios et al. Biodesign: The Process of Innovating Medical Technologies. Cambridge University Press 2009.

“A way to correct apical prolapse in symptomatic women in order to

improve quality of life without invasive surgery.”

Key Need CriteriaMust Haves:

• Comparable Efficacy with Vaginal Vault Suspension

• Does Not Require Removable Insert (Pessary)

• No Permanent Implants (Mesh)

• Covers at Least 60% of Pelvic Organ Prolapse (Pessary)

Nice to Haves:

• Takes < 30 Minutes to Perform

• No Retreatment Needed at Least 6 Months

• Can be Performed in Office Under Local Anesthesia With Minimal Training

5

3

13

6

Stakeholder Analysis and Cycle of Care

Miles Rosen

Disclosures

• Stock Ownership: Pelvalon

Objective

Discuss interrelated roles of stakeholders in translating an innovation to patients.

The Perfect Innovation.

What else matters, right?

5 6

7

7 8

9

8

10/19/2016

1

Intellectual Property

• Peter L. Rosenblatt, MD– Director of Urogynecology, Mount Auburn Hospital,

Cambridge, MA

– Assistant Professor, Harvard Medical School

– BA, Brown University

– MD, Tufts University School of Medicine

– Ob/Gyn, Univ Mass Med School

– FPMRS Fellowship, Brown University

– 14 US patents

Disclosure

• Consultant: American Medical Systems, Boston Scientific Corp Inc., Coloplast, Covidien, Medtronic

• Contracted Research: Boston Scientific Corp. Inc., Coloplast

• Royalty: American Medical Systems, Cook Medical, UpToDate

• Stock Ownership: Pelvalon, Solace

What should you do with your ideas?

• Don’t assume your idea has already been thought of by someone else

• Resist the temptation to tell people your idea before you document

• Document your idea first

– Invention notebook

– Provisional patent

– Non–provisional patent

What is a patent?

• Granted by government to an inventor• Right to exclude others from making, using, selling, and importing an invention for a limited period of time

• In exchange for public disclosure of the invention

• Invention: solution to a specific technological problem– New– Not obvious– Industrial applicability

Patent search

• Do it yourself– uspto.gov

– http://www.epo.org/patents/

– Google.com

– http://toolpat.com

– http://www.patent‐attorney.tv/

• Professional search– Patent attorney

– Patent officer

Provisional patent

• www.uspto.gov

• Description of idea, illustrations

• Cover sheet

• Check ($130 – small business status)

• PTO holds application for 12 months

• Must file non–provisional patent before 12 months for discarded

• Establishes priority date

9

10/19/2016

2

Who owns your ideas?

• Check your contract(s)

• University/Hospital restrictions– Technology transfer office

– Advantages• University pays for prototypes, patents, etc.

• University negotiates with industry

– Disadvantages• Loss of control

• Financial split (typical university)– 25% university

– 25% department

– 25% research

– 25% inventor

Speaking with industry

• Non–disclosure agreement (NDA)– Unidirectional v. bidirectional

– Specify topic of discussion

– Any documentation should stay “Confidential”

– Term of agreement 2 to 5 years

• Allow time for company to evaluate idea– Market research

– Voice of customer

– Accepting rejection

10

Confidential 1

Prototyping, Business Models, and How to Pitch Kristin Johnson, MS

BSME, Purdue University; MS Mat Sc., University of Minnesota

Making Minimally Invasive Surgery TRULY Minimally Invasive

Disclosure2

I have no financial relationships to disclose.

Objective3

Discuss prototyping, business models and how to pitch.

44

Goal: Develop and validate solution quickly• Iterative• Know what questions you want to answer• Move from low to high resolution

http://www.paristechreview.com/wp-content/uploads/2010/11/pic1.png

http://www.3ders.org/images2014/biomechanical-engineer-dragonflex-3d-printed-medical-instrument-4.jpg

ConceptLow Resolution

Quick$

Final solutionHigh ResolutionTime consuming

$$$


Prototyping – Validate Need and Solution

55

Prototyping – Validate Need and Solution


• Observe users holding and ‘using’ prototype• Ask open‐ended questions• Break down into multiple prototypes that correspond

with different functions if necessary

Hysteroscope Example:

Are optics improved? Can you get to anatomy?

Confidential 66

Business Model - What VC’s want to knowWhere do you compete?

How will you differentiate?

What do you need to reach important milestones?

Can you drive to positive gross margin?

Can you protect your idea?

• Market size • Competitor response/strength

• Clinical value proposition • Supporting data

• Cash, Time• Team

• Price you can obtain, is the procedure reimbursed well?

• Disposable / Reusable - COGS

• IP protection


11

Confidential 77

The Pitch

• Engage on an emotional level• Bring your idea to life with passion and energy• Picture = 1,000 words

Video/Prototype = 10,000 words

VC’s pay attention to:• Experience of mgmt. team• Board and advisors• Expressed interest of Strategics in space

• Good pitch deck resource: Guy Kawasaki

https://connections.cu.edu/stories/fetal-surgery-integrated-care-bring-hope-families


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CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

13

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

Panel Session 8: Moving from Idea to Product · Panel Session 8: Moving from Idea to Product . Eric R. Sokol, Chair . Faculty: Kristin Johnson, Miles Rosen, Peter L. Rosenblatt .

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