1HCMDSS Workshop June 3, 2005

The second halfWhat happens after research is complete?

HCMDSS Workshop

June 3, 2005

Sherman Eagles – Medtronic, Inc.

2HCMDSS Workshop June 3, 2005

Barriers

• Medical device manufacturers resist new techniques and methods

• No incentives to cooperate

• Legal and regulatory obstacles to collaboration

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Factors making MD manufacturers resistant to technology transfer

• Lack of awareness

• Conservative nature

• Short development cycle

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Lack of awareness

• Software is not a problem– Far more deaths due to poorly designed human systems

(not much change 5 years after IOM report)

– Most regulatory actions are due to manufacturing

– Most common software error is mis-identification

– No data that shows software is a problem

• Software is not a critical technology– Customers don’t buy software, they buy devices

• Software is easy

5HCMDSS Workshop June 3, 2005

Conservative nature

• Regulatory premarket approval – Don’t change what works

• Lack of predictability costs lots of money

• Liability issues– Will always be sued

• Legacy application– New products are built from previous product

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Short development cycle

• Competition – New features sell products

• Health care cost containment– New products are needed to maintain higher

average selling prices

7HCMDSS Workshop June 3, 2005

Lack of incentive

• IP is a key asset – not much value in working with researchers if they keep the IP

• ROI must be greater than alternative ways to spend the money

• ROI must be relatively short term

8HCMDSS Workshop June 3, 2005

Legal and regulatory barriers

• Liability – Responsibility and ownership not clear

• Anti-trust – No good mechanisms for working with

competitors

• Regulation focused on individual devices, not systems

9HCMDSS Workshop June 3, 2005

What can we do?

• Recognize and address the “product” system– Researchers, manufacturers, regulators, legal

system, customers and end users

• Remove or reduce barriers– NGOs or consortium to hold IP and allow

competitors to work together– New regulatory models that allow flexibility– Gather data on software problems

10HCMDSS Workshop June 3, 2005

• Develop standards – Manufacturers pay attention to guidance from

FDA and EU notified bodies.– FDA and EU rely on standards developing

organizations for experience and expertise– FDA and EU participate on SDOs– Support participation by users and academia

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• Provide incentives for manufacturers to adopt research results– Use purchasing power

• VA network security requirements

– Streamline regulatory approvals

12HCMDSS Workshop June 3, 2005

In Summary

• Research only gets us half way there

• We also need to recognize and address the system that creates products and delivers the new research to the marketplace

13HCMDSS Workshop June 3, 2005

Contact Information

Sherman EaglesTechnical Fellow

Medtronic, Inc7000 NE Central Ave

Minneapolis, MN 55432

763-514-4250763-514-6197 (fax)

sherman.eagles@medtronic.com