The document discusses medical device design and regulatory approval. It provides an overview of Team Consulting, a firm that helps clients design safety critical medical devices. It then summarizes a case study of a normothermic liver perfusion system and a class III medical device. Finally, it outlines considerations for intellectual property, business plans, product design lifecycles, regulatory frameworks, FDA submissions, human factors, and medical system architecture.

1. Designing Safety Critical Medical Devices
Sebastien Cuvelier Mussalian
www.team-consulting.com

2. Summary
Team Consulting, Who we are, What we do?
Case Study:
Normothermic Liver Perfusion System
Class III Investigative Device
A bright idea that works
Intellectual property, business plan & funding
Product design lifecycle
Regulatory framework
FDA submission recommendation
The importance of human factors
Medical system architecture
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3. Team Consulting – Who are we, What we do
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4. Team Consulting - Why Us
Injectors Inhalers Nasal drug delivery Dermal Dispensing and
packaging
Compliance monitoring Diagnostics Medical technology Research instrumentation Metrology
Surgical Implantables Regenerative medicine Optyse Services
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5. Team Consulting - Why Us
We can handle the whole job
A broad team with broad skills
We understand the industry
Life science specialists
Ensuring appealing products
that work
We balance creativity with rigour
We can plan a project to
meet your requirements
Experienced and flexible
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6. Team Consulting – Our Team
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7. Team Consulting - Established & Global
• Established 1986, based in Cambridge UK ISO: 13485 2003
9001 2000
• Working with global client base
• Leading healthcare entirely focused in lifesciences
www.team-consulting.com

8. www.team-consulting.com

9. Regenerative Medicine:
Normothermic Liver Perfusion System
Prototype system design and development
 Development consistent with
performance, cost, usability, regulatory
and transport needs
 System enables organ auto-regulation,
perfusion and oxygen delivery for
metabolism at body temp
 Led development of new technologies,
and integration with established
technologies
 Utilised embedded, safety critical control
systems with advanced GUI
 Achievement of quality delivery against
budget and timescales releases next
funding tranche
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10. Regenerative Medicine:
Normothermic Liver Perfusion System
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11. Regenerative Medicine:
Normothermic Liver Perfusion System
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12. US Clinical Research Organisation
Medtech: Class III Investigative Device
System design and development
 Replacement required for out-dated
clinical research devices – equivalence
essential
 Integration of new and established
technologies, with established user
interaction and procedures
 Includes in-line use of electro-chemical
sensor for continual blood parameter
monitoring
 Utilises embedded, safety critical control
systems with advanced GUI
 Data integrity 21 CFR Part 11 compliant
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13. US Clinical Research Organisation
Medtech: Class III Investigative Device
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14. A bright idea that works
What have you got?
 Successful research results
 New scientific discovery
 Something that you have developed for
another market but could find an
application in the medical market.
 A new procedure
 A new tool
 As far as a proof of concept
We have something that we believe in…
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15. Intellectual Property
Business Plan
Project Brief
Quote & proposals
Funding
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16. Product design lifecycle
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17. Regulatory Framework
 US & EU Framework – FDA Vs. CE marking
 510k vs. PMA, 90d vs. 1yr
 Must be defined at the beginning and on-
going process
 Define your medical classification
 Build your Design History File
 Use of requirement tracking system and
test procedure
 Risk mgt file (60601 3rd ed)
 Beware of SOUP
 Design for clinical trials
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18. FDA submission recommendations
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19. FDA submission recommendation
Concise Claims – Step by step approach
Clinical Trial in the US
Discuss Clinical Trial before submission
Discuss Statistics before submission
Contract a statistician
Ensure trials compare with an FDA predicate
– Think equivalence
Be patient, work with the FDA so they build
up trust
Be ready for delay in project plan – 90 days
means 90 days when the FDA are working
Appoint a regulatory manager
Recommendation from presentation Barrie Hayes-Gill, Monica Healthcare
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20. The importance of human factors
HE 75 … new AAMI standard
ISO 62366
User Research
Who is my end user?
What functions do users need?
What do they want it to look like?
Does it fit with my regulatory approval?
Usability Research
Can they use the functions?
What kind of user interface?
Does it fit with my regulatory approval?
Exploratory Research & Statistical
Research
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21. Medical system architecture
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22. If you have any questions please contact us
Tel: +44 (0) 1799 532768
Email: scm@team-consulting.com
Thank you...
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