Medical Device Innovation: Improving Patient Safety One Device at a Time

1
Medical Device Innovation Improving Patient
Safety One Device at a Time

• Mary Beth Privitera, M. Design
• September 22, 2006

2
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
medical devices help to..

• alleviate pain
• overcome disability
• sustain life

4
medical devices also

• sometimes fail.

5
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
as the healthcare system..

• increases in complexity
• opportunities for use error increase

7
technical efficacy reliability

• are the foundation
• while usability is the differentiating factor
  must be taken in to consideration

8
new devices result from

• the knowledge that our world is not perfect
• that there may just be a better way/method/path

9
good medical device design

• requires an understanding and prioritization of
  feature options and potential design paths by
  users.
• needs
• wants
• nice to haves

10
safety and ease of use

• do not just happen

11
safety and ease of use

• rather
• are the result of a user-centered design process
• the application of human factors

12
what are human factors?

• an understanding of interactions of humans
  other elements within a system.

13
HF evaluations are required by

• FDA requirement per QSR 820.30
• HE 48
• HE 74
• HE 75
• 14971 Risk

14
healthcare is a system

• with many subsystems
• proven facility design improves patient safety
  and the overall experience of healthcare delivery

15

• .but what about device design?

16
where do new ideas begin?

• scientific discovery
• technology advancement
• sociological ideals
• war
• point of care

17
innovation requires

• a balanced attitude
• a knowledge of science coupled with a strong
  desire to explore

18
2 types of innovation

• disruptive innovations
• evolution of existing practices and tools

19
most importantlypartnerships
medicine/clinical practice experience
innovative device design
market business requirements
engineering technology design
20
who are the strategic partners?

• healthcare professionals
• engineers
• business
• design

21
HC professionals are a

• driving force in success
• evaluate proven clinical efficacy but also the
  intuitiveness and feel
• mentorship

22
They also

• prove usability of a device.

23
long term adoption

• relies on the users belief that they can readily
  perform the procedure.
• confidence for 100-100
• expectations considered
• seamless performance
• safety in use

24
safe devices accommodate

• the users need for consistency
• device behaves as expected
• extension of the user

25
safe devices do not tax users memory

• endoscope change in viewpoints 0 degrees vs. 30
  degrees

26
safe devices are not ambiguous

• placement correct size as critical as decision
  of porcine vs. mechanical

27
safe devices provide adequate feedback

• ex. AtriCure generator/handle prevents injury

28
small changes impact usability

• ex. endoscopic grasper jaw movement

29
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
control relationships

• end effector to handle

31
HF thought of as a bridge

• technical capability
• encouraging correct user performance
• discourages or prevents incorrect performance

32
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
For success, device innovators must

• understand the target user, their expectations,
  current practices and use environment.

34
For success, device innovators must

• reconcile engineering requirements, usability
  requirements, and market perceptions.

35
Thank You!