Dreaming Big, Being Small

1. 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 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

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

4. 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 Customer Requirements Protect IP Regulations

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

7. Primary Link between Technology and Market Consumers • Quality System: • Incorporates requirements of consumers and regulators into technology design • Is itself a requirement of numerous jurisdictions Technology Images from: http://medgadget.com/2006/08/forehead_retina_1.html

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: http://en.wikipedia.org/wiki/Main_Page

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

10. 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

13. Where to begin? • Take stock: Determine which requirements are already met by internal processes Standards List all requirements Regulations Customers Business objectives Product/ service Define what must be done to meet all requirements

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: http://www.ghtf.org/

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 company’s 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. Customers Product/ Service specifications Business objectives Quality System Input Requirements Regulations Standards

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!

22. Establishing a Quality System Phase 2: Implementation Denotes DIY tip

23. 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

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

28. 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

30. Quality System Certification • Several conformity assessment bodies exist (aka, registrar or notified body) http://www.intertek-sc.com/index.htm http://www.dekra.com/en/home http://www.saiglobal.com/ http://www.bsiamerica.com/americas/

31. 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)

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

33. 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

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

35. 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

36. DIY Tips

37. 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

38. 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

39. 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

40. End Points

41. 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

42. 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!

43. Implementation Timeline 1 2 3 4