Dreaming Big, Being Small Taking a DIY Approach to Getting a Medical Device to Market January Luczak, PhD, PEng Principal Consultant, JuLise Consulting.

Dreaming Big, Being Small

Taking a DIY Approach to Getting a Medical Device to

Market

January Luczak, PhD, PEngPrincipal Consultant, JuLise Consulting

Winnipeg Manitoba Canada

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Objectives

• To chronicle the progress of a small company’s path towards a functioning, effective quality system for a medical device technology

• To provide some DIY tips learned from the experiences, which may be applied across many industries

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Outline

• Role of a quality system in getting innovation “from bench to bedside”

• Establishing the quality system– Phase 1: Ground work– Phase 2: Implementation– Phase 3: Approval (for quality system

and product)– Phase 4: Continual improvement

• DIY tips – denoted by

Innovative technology -

Now what?

Role of a quality system in getting innovation “from

bench to bedside”

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Factors in Managing Innovation

• Technological innovation is not enough to ensure market entry…

• All factors should be considered throughout product development

Business Objectives

Protect IP

Customer Requirements

Regulations

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Organized Approach to Innovation• A quality

system incorporates all requirements and provides an organized approach to innovation!

Business objectives

Customers

RegulationsStandards

Product/ Service

specifications

Quality System

Input Requirements

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Primary Link between Technology and Market

Images from: http://medgadget.com/2006/08/forehead_retina_1.html

Quality System:•Incorporates requirements of consumers and regulators into technology design

•Is itself a requirement of numerous jurisdictions

Technology

Consumers

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You NEED a Quality System...

• In regions with advanced medical device regulations – e.g., Canada, US, Europe, Australia, Japan:– No quality system = no regulatory

approval– No regulatory approval = no market

entry

Images of flags from: http://en.wikipedia.org/wiki/Main_Page

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You WANT a Quality System...• A quality system is beneficial in

many ways– Increased safety and effectiveness of

a medical device– Reduced liability exposure– Reduced regulatory exposure– Increased customer satisfaction– Increased consistency in internal

operations

Establishing a Quality System

Phase 1: Ground work

Denotes DIY tip

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Case Background

• Case: A small company (< 10 employees) has developed a medical device technology and wants to place it on the market

• Being a small company, there is...– No formal quality system in place– No documented operating procedures– No experience with obtaining

regulatory approval

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Where to begin?

• Determine what standards and regulations apply to the technology– Key standards for medical devices: ISO

13485:2003 and 14971:2009– Regulatory bodies publish lists of

standards to which they require compliance

– Standards exist for most any technology – e.g. involving software, sterilization, electromagnetic radiation

Where to begin?

• Take stock:

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List all requirements

Determine which requirements are

already met by internal processes

Define what must be done to meet all

requirements

Standards

Regulations

Customers

Business objectives Product/

service

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Where to begin?

• Take advantage of guidances!– Free and easily accessible– Exist for most any aspect of quality

system and regulatory requirements (e.g., FDA, Health Canada)

– Global Harmonization Task Force (GHTF) guidances incorporate requirements of several medical device regulations

Image from: http://www.ghtf.org/

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Where to begin?

• Option: Hire consultation – Advises on which standards and

regulations the company needs to follow

– Helps the company define operating procedures

– Assists with applications for regulatory approval

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Pros and Cons of Hiring Consultation• Pros:

– Provides guidance based on experience

– Can bring to light “unwritten rules” – Efficiency

• Cons:– Costly– Difficult to find a consultant with

directly relevant experience – Some may take advantage...

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Developing Core Procedures

• Formalized procedures bring together requirements of regulations and standards, and a company’s operation requirements

• Processes that may already exist:– Purchasing– Design and Development– Production

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Developing Core Procedures

• Processes that may not already exist:– Internal Audits– Corrective Action, Preventive Action

(CAPA)– Post-market surveillance– Formal management of records and

documents, and change control

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Design and Development

Production

All requirements

met?

Can improvements

be made?

Release product/ service

Marketing and Surveillance

Define and implement CA

Define and implement PA

YES

YES

NO

NO

Monitoring and Measurement

Commitment to continual

improvement

Resources management

Control of documents and

records

Change control

Quality System Input Requirements

Business objectives

Customers

RegulationsStandards

Product/ Service

specificationsQuality

System Input

Requirements

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Assigning Responsibilities

• Each employee should be delegated responsibilities for quality system requirements that pertain to their positions– There should be a person dedicated to

managing the quality system– At least two internal auditors will be

needed• Training should take precedence

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Assigning Responsibilities

• Take a team approach to establishing a quality system– Each employee should be aware of

their contributions to the success of the quality system

– Employee attitude is the most important factor that can assure an effective quality system!

Establishing a Quality System

Phase 2: Implementation

Denotes DIY tip

Implementation of Key Processes• In the next slides, focus is on:

– Document and Records Management– Change Control– Monitoring and Measurement

• Implementation is the most time consuming phase

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Document and Record Management• Every regulation and standard

contains definitive requirements for documents and records, such as– NB: Design documents and records– Minutes, reports, filled-out forms– Records of distribution and feedback– Documents of external origin, e.g.

correspondence with regulators

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Change Control

• Many types of changes must be controlled, such as– Changes to design – Changes in personnel

• Change control = recording changes, reasons for changes, and approval of changes

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Monitoring and Measurement

• CA must be undertaken when a nonconformity has occurred

• PA must be undertaken to prevent a nonconformity from occurring in the future

• Internal Audits measure processes effectiveness

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Design and Development

Production

All requirements

met?

Can improvements

be made?

Release product/ service

Marketing and Surveillance

Define and implement CA

Define and implement PA

YES

YES

NO

NO

Monitoring and Measurement

Commitment to continual

improvement

Resources management

Control of documents and

records

Change control

Quality System Input Requirements

Establishing a Quality System

Phase 3: Approval – for the product AND quality system

Denotes DIY tip

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Quality System Certification

• Certification to the ISO 13485:2003 standard is necessary for certain jurisdictions, including Canada and the EU

• Certification process incorporates specific requirements of those jurisdictions, so that one external audit process can cover all requirements

Quality System Certification

• Several conformity assessment bodies exist (aka, registrar or notified body)

http://www.bsiamerica.com/americas/

http://www.dekra.com/en/home

http://www.intertek-sc.com/index.htm

http://www.saiglobal.com/

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Regulatory Approval for the Technology• Depending on the regulatory

approval sought, approval may entail:– Filling out a license application

(Canada) (requires ISO 13485 cert.)– Undergoing an assessment of the

technical documentation (requires ISO 13485 cert.)

– Premarket approval (PMA) or 510(k) submission (US)

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Regulatory Approval for the Technology• It is possible to prepare

applications and submissions for regulatory approval without consultation– There are guidances – e.g., FDA offers

several guidances on PMA and 510(k)

• Consultant may expedite the process

Stats on Regulatory Submissions…• Reported in May 2011: Only 4% of

small medical device companies in the US seek FDA approval as the first choice– Small companies are more likely to

incur costly and time-consuming difficulties in the 510(k) process

– Process takes longer – 330 days vs. 170 days for large companies

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Establishing a Quality System

Phase 4: Continual improvement

Denotes DIY tip

Continual Improvement

• Certification, regulatory approvals -– Don’t “rest on your laurels” – keep up

the good work!

• Improvement of the product AND quality system should be ongoing

• Use post-market surveillance, internal audits, and CAPA to identify and address problems and opportunities for improvement 35

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DIY Tips

Summary of DIY Tips

• Phase 1: Ground work– Determine what standards and

regulations apply to the technology– Take stock– Take advantage of guidances– Delegate responsibilities for quality

system requirements to all employees– Training– Team approach 37

Summary of DIY Tips

• Phase 2: Implementation– Pretty much all DIY; only the

company’s own employees can put the quality system to work

– Perform internal audits to measure the effectiveness of implementation

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Summary of DIY Tips

• Phase 3: Approval for product AND quality system– Prepare applications and submissions

for regulatory approval without consultation

• Phase 4: Continual improvement– Use post-market surveillance, internal

audits, and CAPA to identify and address problems and opportunities for improvement

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End Points

End Points

• Initial consultation may be beneficial, but beware…– Consultants should develop procedures

based on the company’s needs and processes, and NOT provide generic procedures

– Consultants should have directly relevant experience

• Guidances are very useful and widely available 41

End Points

• Maintain a positive attitude towards the quality system– It should be viewed as a helpful tool for

developing and producing a safe and effective device, rather than as a burden

– It should not be implemented just to service auditors/regulators, but rather, embraced as an organized approach to innovation!

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Implementation Timeline

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