Legal and Business Challenges for the Medical Device Startup New Technologies, Challenges and Opport

1
Legal and Business Challenges for the Medical
Device Start-up New Technologies, Challenges
and Opportunities for the Medical Device
Industry - Tufts - NEMC
Stephen M. Andress
June 11, 2004
2
Background

• Hub Ranks Top in Life Sciences
• The Boston Globe, June 8, 2004

3
Challenges - Enforcement

• US Picking Up Pace of Device
• Inquiries
• The Boston Globe, May 19, 2004

4
Challenges - Managing Conflicts

• Harvard Medical School Amends
• Policies
• The Boston Globe, May 29, 2004

5
Challenges - Product Development

• . . . in a highly regulated environment
• 510(k) vs. PMA
• Reimbursement vs. FDA clearance

6
Challenges - Litigation

• Patents
• Product Liability

7
Challenges - Workforce

• Mobility - Concern about departure of key
  employees and trade secrets
• Liability - Employee claims/litigation

8
Conclusion

• Medical Device Industry a Major Strength of our
  New England Economy
• Be Careful Out There

9
Thank You!

• My name is Steve Andress and I have approved this
  message.