Team Medical-Bringing New Medical Products to Life Logo
Team Medical, LLC • 300 15th Street • Boulder, CO 80302 • Phone:  303-546-6400

Contact us at Team@TeamMedical.us
Consulting Services:
Assess and Improve Medical Device
Products, Technology, R&D, and Feasibility


Team Medical, LLC
 
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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.
 
 

Product experience includes operating room, critical care, diagnostics, therapeutic, monitoring, instruments, disposables, cardiac care, signal processing, medication delivery

 

Over 100 medical device projects have been done

 

Hospital and alternate care site products

 

Mechanical, electronic, software systems

 

Domestic and overseas

 

 
Product and Project Feasibility
 
 

Will it work?

 

Can it be manufactured?

 

How much will it cost to make??

 

Will it be reliable?

 

What could go wrong?

 
 
Cogent reports and briefings get to the core issues
 
 

Project review and audit

 

Technical review and audit

 

Capability assessment

 

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


 

What are the real unknowns that can affect development cost and product introduction schedule?

 

What improvements in the team can help complete R&D and get the product manufactured?

 

Is the schedule realistic and how much longer could it take?

 

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


 

Engineering calculations, models, simulations, prototypes to evaluate and anticipate performance

 

Medical Device Failure Analysis

 

Testing, Product Tear Down, and Analysis in our laboratory

 

 

Intellectual property review


 

As the inventor of on over 25 U.S. Medical Device Patents my experience includes reviewing hundreds of patents to ascertain differences and similarities

 

How unique is the technology forming a company's foundation?

 

Evaluate medical technology to distinguish it from what has been patented.


 

Product research and development, engineering, and production startup

 
 

detailed technical and engineering design for products and manufacturing processes

 

surgical instrument coating design and application

 

product requirements review and recommendations

 

design review

 

product development process review and improvement

 

preproduction quality assurance audit, review, recommendations

 

510(k) review, preparation

 

Due diligence by reviewing or assessing technology, products, or businesses

 
 

technical feasibility, including using engineering analysis and laboratory testing

 

competitive position and business potential

 

intellectual property position

 

product development cost estimates

 

product development status and schedule

 

management and technical team requirements and skills

 

roadblocks to remove or miracles that need to occur before success can happen

 

probability of technical success (product produced at target cost) assessment

 
 

Use outside review to anticipate problems and identify solutions to control costs and schedules.


 

Can the proposed team make it work and get it manufactured?

 

Is the schedule realistic and how much longer could it take?

 

What are the real unknowns that can affect development cost and product introduction schedule?


 

Hazard, Failure, and Risk Analysis and Assessment


 

Safety Analysis

 

Testing, Product Tear Down & Analysis in our laboratory

 

Failure/Fault Analysis,

 

Failure Mode Effects Analysis (FMEA),

 

Fault Tree Analysis (FTA),

 

Hazard Analysis,

 

Risk Analysis


 

The art and science of using contract product developers


 

How to work with contract product developers and efficiently move through R&D and into manufacturing

 

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

 

How to manage contract product developers and other outside experts

 

I can help you efficiently work with outside resources

 

What works and does not work when using contract product developers

 

What contract product developers do best and what they do poorly

 

When to not rely on outside product developers and other outside experts

 

How to fix problems with contract product developers on a project

 

How to avoid problems with contract product developers

 

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

 
 

orthopaedic instruments, including RF ablation, cutting, and tissue shrinkage

 

monopolar and bipolar electrosurgical instruments and generators

 

minimally invasive surgical instruments

 

endoscopes -- cardiac, vascular, urologic

 

Cardiac and vascular care and monitoring

 
 

intracardiac catheters

 

multiparameter hemodynamic monitor

 

cardiac output

 

left ventricular assist device (LVAD)

 

Patient monitoring and support

 
 

noninvasive blood glucose meters

 

pulse oximeters

 

spirometers

 

implantable bioartificial pancreas

 

home hemodialysis system

 

Drug delivery systems

 
 

hospital infusion pumps

 

ambulatory infusion pumps

 

miniature infusion pumps

 



Medical Device R&D Expert Capabilities

Warren P. Heim Medical R&D Expert Brochure (pdf file)

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

    (303) 546-6400
  Team@TeamMedical.us

Team Medical is managed by Warren P. Heim, P.E., inventor on over 25 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). Liberal arts and engineering degrees from Dartmouth College in 1973, 1974, 1975
Warren on Pawnee Peak Summit