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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
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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
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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
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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!
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Establishing a Quality System
Phase 2: Implementation
Denotes DIY tip
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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
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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
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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
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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
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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
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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
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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
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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
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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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1
2
3
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