This document provides guidance for medical device companies on finding the right partner for product development. It discusses challenges such as aggressive timelines, resource constraints, technical issues, intellectual property, regulatory standards, and testing. The ideal partner brings necessary resources, communicates status, provides quality results, and has experience resolving various challenges. When partnering, companies should create detailed project plans, identify obstacles early, and insist on regular communication. The partner should augment internal capabilities and expertise to help overcome constraints and issues.
3. Challenges often the same - regardless of
company size
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Aggressive timelines
Resource constraints – people, $$, equipment
Technical issues to resolve
Capturing Intellectual Property opportunities
Meeting regulatory standards
Independent testing
4. What I look for in critical Partners…
• Brings the resources needed
▫ An extension of the company
▫ Ability to grow with the company
• Communicates status, works to meet timeline
▫ Discuss issues in timely manner
▫ Honest
• Provides quality results
▫ Documented
▫ Controlled
5. Overcoming Time Constraints
• Critical to know realistic timelines
▫ Develop from recent experience
▫ Need consideration of all aspects of project
Prototyping expectation - how many cycles, vendor turn time
Documentation requirements
Testing – e.g. sterilization, biocompatibility, life cycle testing
Regulatory filing
▫ Beware of “project creep”
• Partner should bring
▫ Recent and relevant experience
▫ Bandwidth to meet needs, augment in-house staff
▫ Regular communication
6. Overcoming Time Constraints
project planning is first step
• Create detailed plan
▫ Microsoft Project, OpenProj
▫ Use Partner to validate plan
• Identify obstacles early
• Use milestones to assess progress
• Communicate plan
7. Overcoming Resource Constraints – people, $$
• Recognize internal limitations
▫ Budget
▫ Hiring options – timing, long term need
▫ Breadth of knowledge required
▫ Space, equipment
• Partner should bring
▫ Skilled resources – time, reduced cycles
▫ Preferably reduced labor costs
▫ Necessary equipment, tools and space
8. Overcoming Resource Constraints
people make the difference…
• Consider skills Partner brings
▫ Biomedical, mechanical, electrical
▫ Material scientist
▫ Specialists – e.g. CFD, FEA
▫ Quality capabilities
▫ Manufacturing for pilot, full scale
10. Overcoming Resource Constraints
range of capabilities – POC to full scale
• Consider mid and longer term needs
• Adequate rating and size of cleanroom and manufacturing
space
Assembly
Packaging
Sterilization
Logistics /
Distribution
11. Resolving Technical Issues
• Determine what to keep in-house
▫ Not all challenges are best kept internal
▫ Identify core competency – likely internal focus
▫ Evaluate internal personnel skills, accept limitations
• Partner should bring
▫ Relevant personnel expertise
▫ Capability to close the issue
12. Resolving Technical Issues
consider focus of Partner
• Complexity of design and processing
▫ Implant, delivery system, specialty
• Depth of capabilities
February 2011
Center for Devices and Radiological Health
U.S. Food and Drug Administration
13. Resolving Technical Issues
implants
• Often requires specific skills and experience
• Early Partner involvement reduces risk of setbacks
▫ Regulatory considerations
▫ Long term testing
14. Resolving Technical Issues
complex catheters or delivery systems
• Don’t underestimate scope of work
▫ Breadth of Partner
▫ Unidentified challenges
▫ A device is not successful if not properly delivered
15. Resolving Technical Issues
consider experience
• Areas of expertise
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Coronary
Endovascular
Sterilization
Regulatory
Competitive testing
Failure analysis
• Full Systems
▫ Stent grafts
▫ Guidewires
▫ Control box and connecting
cables
• Components or Sub
Assemblies
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Occlusion coils
Balloons
Stents and stent grafts
Outer shafts
Insert molded tips
Injection molded
And more…
17. Capturing Intellectual Property (IP) Opportunities
• Development efforts need to lead to IP strength
▫ Recognition of corporate value
▫ Out of box thinking
• Partner should bring
▫ Unique capabilities
▫ Thorough documentation
▫ Opportunity to build YOUR Intellectual Property
• Ensure clear ownership of IP before starting
18. Meeting Regulatory Standards
• Recognition of standards required to meet plans
▫ EU standards are being increasingly enforced
▫ US standards remain high
▫ Medical devices require proper documentation
• Partner should bring
▫ Preferably
ISO certification
FDA registration
▫ Maintained and audited quality system
▫ Ability to maintain and certify material traceability
19. Performing Device Testing, V&V
• Testing needs should consider:
▫ Intent of data
▫ Need for independent test lab
▫ Equipment and tooling needs
▫ Conformance to applicable standards
• Partner should bring
▫ Experience and necessary skills
▫ Complete documentation
▫ Availability of critical equipment or tools
20. Summary…
• Consider in detail
▫ People
▫ Track record, experiences
▫ Scope and breadth of work
• Closing a deal
▫ Evaluate proposal for insights and completeness
▫ Question ambiguities
▫ Consider how change in requirements is addressed
• Insist on regular communication
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22. Company Background
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Family owned company in business for 18 years
Corporate office outside Chicago, Illinois
Added manufacturing facility in 2008
Opened Charlotte, North Carolina office in 2012
Expanding into California in 2014!
23. Our Business Focus
• Medical Device design, development and manufacturing
• Specialize in products requiring unique processes,
materials and designs
• Complex catheters, catheter components and implants
• Testing and regulatory filing per industry standards
Complex Catheters
Difficult Injection
Molding
Mechanics &
Materials
Soft Tissue
Implants
Bioabsorbable
Materials