Published on February 22, 2014
Finding the Right Partner for Medical Device Companies Eric Leopold, VP of Business Development February 11, 2014
My experiences - large and small companies
Challenges often the same - regardless of company size • • • • • • Aggressive timelines Resource constraints – people, $$, equipment Technical issues to resolve Capturing Intellectual Property opportunities Meeting regulatory standards Independent testing
What I look for in critical Partners… • Brings the resources needed ▫ An extension of the company ▫ Ability to grow with the company • Communicates status, works to meet timeline ▫ Discuss issues in timely manner ▫ Honest • Provides quality results ▫ Documented ▫ Controlled
Overcoming Time Constraints • Critical to know realistic timelines ▫ Develop from recent experience ▫ Need consideration of all aspects of project Prototyping expectation - how many cycles, vendor turn time Documentation requirements Testing – e.g. sterilization, biocompatibility, life cycle testing Regulatory filing ▫ Beware of “project creep” • Partner should bring ▫ Recent and relevant experience ▫ Bandwidth to meet needs, augment in-house staff ▫ Regular communication
Overcoming Time Constraints project planning is first step • Create detailed plan ▫ Microsoft Project, OpenProj ▫ Use Partner to validate plan • Identify obstacles early • Use milestones to assess progress • Communicate plan
Overcoming Resource Constraints – people, $$ • 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
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
Overcoming Resource Constraints consider breadth of Partner’s capabilities Catheter assembly ▫ Braiding ▫ Fusing & laminating ▫ Balloon blowers ▫ Hot die necking ▫ Injection molding ▫ Tube forming ▫ Heating ▫ Curing ▫ Optical inspection ▫ Tube flaring ▫ Controlled tube cutting ▫ Soldering ▫ Marker crimping Other ▫ Machine shop ▫ 3D modeling ▫ Fluidized bed or sand bath ▫ Stent crimping ▫ Wire rolling ▫ Laser welding ▫ Ultrasonic welding ▫ Tube flaring ▫ Vacuum sealer ▫ Packaging
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
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
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
Resolving Technical Issues implants • Often requires specific skills and experience • Early Partner involvement reduces risk of setbacks ▫ Regulatory considerations ▫ Long term testing
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
Resolving Technical Issues consider experience • Areas of expertise ▫ ▫ ▫ ▫ ▫ ▫ Coronary Endovascular Sterilization Regulatory Competitive testing Failure analysis • Full Systems ▫ Stent grafts ▫ Guidewires ▫ Control box and connecting cables • Components or Sub Assemblies ▫ ▫ ▫ ▫ ▫ ▫ ▫ Occlusion coils Balloons Stents and stent grafts Outer shafts Insert molded tips Injection molded And more…
Resolving Technical Issues consider material experience • • • • • • • • Melt flow polymers Silicone Durometer range Thermoset polymers Radiopacity additives Bioabsorbable Colorants Epoxies • • • • • Metal tubes or wires Nitinol Tungsten RO metals Fabrics
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
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
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
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
Company Background • • • • • 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!
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
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