Consulting Services:
Assess and Improve Medical Device
Products, Technology, R&D, and Feasibility
Team Medical, LLC
Whatever happened to that guy you knew who loved science and technology and
could explain anything?
He has been doing medical device R&D for over 30 years and has designed and evaluated over 100 products.
When you need to know the real story of medical device R&D or technology call Team Medical and ask for Warren P. Heim, P.E.
Hands-on experience makes a difference.
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Product experience includes operating room, critical care,
diagnostics, therapeutic, monitoring, instruments, disposables, cardiac care,
signal processing, medication delivery
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Over 100 medical device projects have been done
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Hospital and alternate care site products
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Mechanical, electronic, software systems
Product and Project Feasibility
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Can it be manufactured?
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How much will it cost to make??
Cogent reports and briefings get to the core issues
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Project review and audit
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Technical review and audit
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Concrete steps to improve & move forward
Medical Device R&D: Project Evaluation, Analysis, and Improvement
Over 30 years of Medical Device R&D Experience to Understand and Improve
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What are the real unknowns that can affect development cost and product introduction schedule?
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What improvements in the team can help complete R&D and get the product manufactured?
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Is the schedule realistic and how much longer could it take?
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What management improvements can keep or help get the project on schedule and budget?
You Get Facts That Back Up Our Conclusions
Medical Device Expert Engineering and Analysis That Produces Facts
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Engineering calculations, models, simulations, prototypes to evaluate and anticipate performance
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Medical Device Failure Analysis
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Testing, Product Tear Down, and Analysis in our laboratory
Intellectual property review
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As the inventor of on over 25 U.S. Medical Device Patents my experience includes reviewing hundreds of patents to ascertain differences and similarities
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How unique is the technology forming a company's foundation?
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Evaluate medical technology to distinguish it from what has been patented.
Product research and development, engineering, and production startup
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detailed technical and engineering design for products and manufacturing processes
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surgical instrument coating design and application
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product requirements review and recommendations
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product development process review and improvement
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preproduction quality assurance audit, review, recommendations
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510(k) review, preparation
Due diligence by reviewing or assessing technology, products, or businesses
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technical feasibility, including using engineering analysis and laboratory testing
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competitive position and business potential
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intellectual property position
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product development cost estimates
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product development status and schedule
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management and technical team requirements and skills
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roadblocks to remove or miracles that need to occur before success can happen
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probability of technical success (product produced at target cost) assessment
Use outside review to anticipate problems and identify solutions
to control costs and schedules.
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Can the proposed team make it work and get it manufactured?
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Is the schedule realistic and how much longer could it take?
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What are the real unknowns that can affect development cost and product introduction schedule?
Hazard, Failure, and Risk Analysis and Assessment
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Testing, Product Tear Down & Analysis in our laboratory
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Failure/Fault Analysis,
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Failure Mode Effects Analysis (FMEA),
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Fault Tree Analysis (FTA),
The art and science of using contract product developers
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How to work with contract product developers and efficiently move through R&D and into manufacturing
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I understand how contract product developers and outside experts think and work –
I have been a consultant and contract medical product developer for over 20 years
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How to manage contract product developers and other outside experts
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I can help you efficiently work with outside resources
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What works and does not work when using contract product developers
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What contract product developers do best and what they do poorly
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When to not rely on outside product developers and other outside experts
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How to fix problems with contract product developers on a project
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How to avoid problems with contract product developers
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I can help you get projects back on track when using outside developers and experts
When you need a real hands-on expert on medical device technology and development give me a call.
I’m here to help you.
A short list of example products includes:
Surgical instruments
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orthopaedic instruments, including RF ablation, cutting, and tissue shrinkage
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monopolar and bipolar electrosurgical instruments and generators
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minimally invasive surgical instruments
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endoscopes -- cardiac, vascular, urologic
Cardiac and vascular care and monitoring
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multiparameter hemodynamic monitor
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left ventricular assist device (LVAD)
Patient monitoring and support
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noninvasive blood glucose meters
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implantable bioartificial pancreas
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home hemodialysis system
Drug delivery systems
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hospital infusion pumps
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ambulatory infusion pumps
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miniature infusion pumps
Call now for a free consultation. We love solving problems and a telephone call may be all that you need.
Contact us
Team Medical, LLC
300-15th Street
Boulder, CO 80302
Team Medical is managed by Warren P. Heim, P.E., inventor on over 30 issued U.S. patents, successful entrepreneur with over 30 years of medical device experience, who has provided consulting services to many firms, including Abbott Laboratories, C.R. Bard, Baxter, Edwards Life Sciences, Linvatec (division of Conmed), Medtronic, St. Jude Medical, Johnson & Johnson, Smith+Nephew, Valleylab (Covidien)-Medtronic.
Liberal arts and engineering degrees from Dartmouth College in 1973, 1974, 1975
