1. Medical Device Innovation: Improving Patient Safety One Device at a Time Mary Beth Privitera, M. Design September 22, 2006

2. Dept. of Biomedical Engineering a medical device is... any tool used for diagnosis and therapeutic treatment over 1800 categories which vary in complexity & risk bandages to implanted heart valves

3. Dept. of Biomedical Engineering medical devices help to.. alleviate pain overcome disability sustain life

4. Dept. of Biomedical Engineering medical devices also … sometimes fail.

5. Dept. of Biomedical Engineering problem scope over 1/3 of medical device (incident) reports mention errors. about 44% of product recalls involve design literature cites errors as a prominent problem

6. Dept. of Biomedical Engineering as the healthcare system.. increases in complexity opportunities for use error increase

7. Dept. of Biomedical Engineering technical efficacy & reliability are the foundation… while usability is the differentiating factor & must be taken in to consideration

8. Dept. of Biomedical Engineering new devices result from… the knowledge that our world is not perfect that there may just be a better way/method/path

9. Dept. of Biomedical Engineering good medical device design… requires an understanding and prioritization of feature options and potential design paths by users. needs wants nice to haves

10. Dept. of Biomedical Engineering safety and ease of use do not just happen…

11. Dept. of Biomedical Engineering safety and ease of use rather… are the result of a user-centered design process the application of human factors

12. Dept. of Biomedical Engineering what are human factors? an understanding of interactions of humans & other elements within a system.

13. Dept. of Biomedical Engineering HF evaluations are required by FDA requirement per QSR 820.30 HE 48 HE 74 HE 75 14971 Risk

14. Dept. of Biomedical Engineering healthcare is a system with many subsystems proven facility design improves patient safety and the overall experience of healthcare delivery

15. Dept. of Biomedical Engineering ….but what about device design?

16. Dept. of Biomedical Engineering where do new ideas begin? scientific discovery technology advancement sociological ideals war point of care

17. Dept. of Biomedical Engineering innovation requires… a balanced attitude a knowledge of science coupled with a strong desire to explore

18. Dept. of Biomedical Engineering 2 types of innovation: disruptive innovations evolution of existing practices and tools

19. Dept. of Biomedical Engineering most importantly…partnerships medicine/clinical practice & experience medicine/clinical practice & experience engineering technology & design engineering technology & design market & business requirements market & business requirements innovative device design innovative device design

20. Dept. of Biomedical Engineering who are the strategic partners? healthcare professionals engineers business design

21. Dept. of Biomedical Engineering HC professionals are a driving force in success evaluate proven clinical efficacy but also the “intuitiveness” and “feel” mentorship

22. Dept. of Biomedical Engineering They also… prove usability of a device.

23. Dept. of Biomedical Engineering long term adoption… relies on the user’s belief that they can readily perform the procedure. confidence for 100%-100% expectations considered seamless performance safety in use

24. Dept. of Biomedical Engineering safe devices accommodate the users need for consistency device behaves as expected extension of the user

25. Dept. of Biomedical Engineering safe devices do not tax users memory endoscope change in viewpoints 0 degrees vs. 30 degrees

26. Dept. of Biomedical Engineering safe devices are not ambiguous placement & correct size as critical as decision of porcine vs. mechanical

27. Dept. of Biomedical Engineering safe devices provide adequate feedback ex. AtriCure generator/handle prevents injury

28. Dept. of Biomedical Engineering small changes impact usability ex. endoscopic grasper & jaw movement

29. Dept. of Biomedical Engineering cognitive & tactile considerations cognitive interface form of handle & recognition tactile interface allow for easy control access forces acting on control should be minimal adequate surface purchase and contours provide feedback where possible

30. Dept. of Biomedical Engineering control relationships end effector to handle

31. Dept. of Biomedical Engineering HF thought of as a bridge technical capability encouraging correct user performance discourages or prevents incorrect performance

32. Dept. of Biomedical Engineering Physicians have an…. Immediate response when introduced to a new device Inquisitive and judgmental. Drastic change from traditional product configurations may be resisted. Upon first sight, users may be able to intuitively detect challenges

33. Dept. of Biomedical Engineering For success, device innovators must… understand the target user, their expectations, current practices and use environment.

34. Dept. of Biomedical Engineering For success, device innovators must… reconcile engineering requirements, usability requirements, and market perceptions.

35. Dept. of Biomedical Engineering Thank You!