1. Sorenson Medical, West Jordan, Utah USA Medical Device Development Robert Hitchcock, Ph.D. Director of Engineering & Technology Development Sorenson Medical, Inc.

2. Sorenson Medical, West Jordan, Utah USA What is a Medical Device? 1.recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2.intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3.intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

3. Sorenson Medical, West Jordan, Utah USA Medical Device Industry Global market for medical devices exceeds $200B US market ~ 42% of WW market US innovation drives the market (more US producers than rest of world combined) However.. it is increasingly difficult to commercialize Consumer v. agency regulation Increasing control improves safety and effectiveness at the expense of commercial progress Overseas manufacturing and product launch

4. Sorenson Medical, West Jordan, Utah USA

5. Picture of medical devices

6. Sorenson Medical, West Jordan, Utah USA Medical Device Regulation 1976 Medical device amendments to the FD&CA 1978 GMP 1987 – 1989 Process validation, design control 1990 SMDA – 44% of recalls due to faulty design 1996 QSR – harmonization, FDA, MDD, ISO

7. Sorenson Medical, West Jordan, Utah USA The Big Picture - 21 CFR part 820 Quality System Regulation Subpart A – General Provisions 820.1Scope 820.3Definitions 820.5Quality System Subpart B – Quality System Requirements 820.20Management Responsibility 820.22Quality audit 820.25Personnel Subpart C – Design controls 820.30Design controls Subpart D – Document controls 820.40Document controls Subpart E – Purchasing controls 820.50Purchasing controls Subpart F – Identification and traceability 820.60Identification 820.65Traceability Subpart G – Production and process controls 820.70Production and process controls 820.72Inspection, measuring and test equipment 820.75Process validation Subpart H – Acceptance activities 820.80Receiving, in-process and finished device accept. 820.86Acceptance status Subpart I – Nonconforming product 820.90Nonconforming product Subpart J – Corrective and preventative action 820.100Corrective and preventative action Subpart K – Labeling and packaging control 820.120Device labeling 820.130Device packaging Subpart L – Handling, storage, distribution and installation 820.140Handling 820.150Storage 820.160Distribution 820.170Installation Subpart M – Records 820.180General requirements 820.181Device master record 820.184Device history record 820.186Quality system record 820.198Complaint files Subpart N – Servicing 820.200Servicing Subpart O – Statistical techniques 820.250Statistical techniques

8. Sorenson Medical, West Jordan, Utah USA Design Control Design & Development Planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file

9. Sorenson Medical, West Jordan, Utah USA SMI Product Design & Development

10. Sorenson Medical, West Jordan, Utah USA Three Key Elements 1.Design Input 2.Risk Analysis 3.Design Output

11. Sorenson Medical, West Jordan, Utah USA Design Input User Needs –what & why stated in user terms Marketing Requirements –measurable, engineering terms

12. Sorenson Medical, West Jordan, Utah USA Design Input – User Needs Over the Needle Catheter Infuse fluids into subcutaneous tissue Sharp enough to penetrate skin easily Simple to remove needle from catheter

13. Sorenson Medical, West Jordan, Utah USA Design Input – Marketing Requirements Over the Needle Catheter WFI infused at 100 ml/hr, backpressure not to exceed 10 psi Max insertion force through 5 mil latex = 3N Max force to remove needle = 1N

14. Sorenson Medical, West Jordan, Utah USA Design Concept

15. Sorenson Medical, West Jordan, Utah USA Risk Analysis Failure mode Potential effects Severity –1 to 10 (negligible to potential for multiple deaths) Potential causes Likelihood –1 to 10 ( 1 in 2) Risk –Likelihood / severity matrix Mitigation

16. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

17. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

18. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

19. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

20. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

21. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

22. Sorenson Medical, West Jordan, Utah USA Design Output - Specifications

23. Sorenson Medical, West Jordan, Utah USA Design Output – Prototypes

24. Sorenson Medical, West Jordan, Utah USA Design Output – Testing & Data Verification Validation

25. Sorenson Medical, West Jordan, Utah USA The Big Picture - 21 CFR part 820 Quality System Regulation Subpart A – General Provisions 820.1Scope 820.3Definitions 820.5Quality System Subpart B – Quality System Requirements 820.20Management Responsibility 820.22Quality audit 820.25Personnel Subpart C – Design controls 820.30Design controls Subpart D – Document controls 820.40Document controls Subpart E – Purchasing controls 820.50Purchasing controls Subpart F – Identification and traceability 820.60Identification 820.65Traceability Subpart G – Production and process controls 820.70Production and process controls 820.72Inspection, measuring and test equipment 820.75Process validation Subpart H – Acceptance activities 820.80Receiving, in-process and finished device accept. 820.86Acceptance status Subpart I – Nonconforming product 820.90Nonconforming product Subpart J – Corrective and preventative action 820.100Corrective and preventative action Subpart K – Labeling and packaging control 820.120Device labeling 820.130Device packaging Subpart L – Handling, storage, distribution and installation 820.140Handling 820.150Storage 820.160Distribution 820.170Installation Subpart M – Records 820.180General requirements 820.181Device master record 820.184Device history record 820.186Quality system record 820.198Complaint files Subpart N – Servicing 820.200Servicing Subpart O – Statistical techniques 820.250Statistical techniques