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

2 Objectives To chronicle the progress of a small companys 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

3 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

5 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

6 Organized Approach to Innovation A quality system incorporates all requirements and provides an organized approach to innovation! Business objectives Customers Regulations Standards Product/ Service specifications Quality System Input Requirements

7 Primary Link between Technology and Market Images from: Quality System: Incorporates requirements of consumers and regulators into technology design Is itself a requirement of numerous jurisdictions Technology Consumers

8 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:

9 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

11 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

12 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: 13 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

14 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:

15 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

16 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...

17 Developing Core Procedures Formalized procedures bring together requirements of regulations and standards, and a companys operation requirements Processes that may already exist: –Purchasing –Design and Development –Production

18 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

19 Business objectives Customers Regulations Standards Product/ Service specifications Quality System Input Requirements

20 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

21 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 23

24 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

25 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

26 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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Establishing a Quality System Phase 3: Approval – for the product AND quality system Denotes DIY tip

29 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)

31 Regulatory Approval for the Technology Depending on the regulatory approval sought, approval may entail: –Filling out a license application (Canada) (requires ISO cert.) –Undergoing an assessment of the technical documentation (requires ISO cert.) –Premarket approval (PMA) or 510(k) submission (US)

32 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 33

34 Establishing a Quality System Phase 4: Continual improvement Denotes DIY tip

Continual Improvement Certification, regulatory approvals - –Dont 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

36 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 companys own employees can put the quality system to work –Perform internal audits to measure the effectiveness of implementation 38

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 39

40 End Points

Initial consultation may be beneficial, but beware… –Consultants should develop procedures based on the companys 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! 42

Implementation Timeline