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 Expert  724264

Expert in Medical Device Design and Manufacture

Available for your Consulting and Expert Witness Needs

Minnesota (MN)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert moved on to research and development positions. For the last fifteen years he has worked as a "start-up" specialist leveraging his design with manufacturing skills on a scale appropriate for the client's budget and business objectives.

disposable medical device


medical device design


medical device product development

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Minneapolis, Minnesota;  Saint Paul, Minnesota;  Rochester, Minnesota;  Burnsville, Minnesota;  Saint Cloud, Minnesota;  Eden Prairie, Minnesota;  Minnetonka, Minnesota;  and Eau Claire, Wisconsin.

Often requested
with this expert:

Medical Device Research and Development
Medical Technology
FDA Regulations, Labeling and Compliance; Medical Devices,...
Biomedical Material Technology

Year   Degree   Subject   Institution  
1980   BA   Liberal Arts   University of St. Thomas  
1980   BS   Mechanical Engineering   Washington University  
1987   MEA   Engineering Management   University of Utah  

Work History:
Years   Employer   Department   Title   Responsibilities

2007 to 2010


Cardious, Inc.



President (Founder)


He is the owner and founder of this medical device start-up company.

Responsible for: Raising capital, Conceiving design, Fabricating product, Conducting animal studies, Prosecuting IP, Developing marketing plan.

1995 to


Expert's Firm





As principal employee of the company, he is responsible for the design and development of disposable and implantable medical devices. He has developed his own proprietary products and provides consulting to client companies in the areas of product development, manufacturing, and regulatory submissions. Representative product areas include balloon angioplasty catheter and stent, embolic filter guidewire, percutaneously delivered aortic valve, brachytherapy catheter, RF instrument and catheter, fiber optic endoscopy device, and blood pressure monitoring devices. He has provided full design and project management, from initial design concept through regulatory approval and manufacturing start-up. A recent project entailed the complete responsibility for the design, process development, manufacturing start-up, and ISO/CE approval of an angioplasty catheter product line in Shenzhen, China.

1988 to 1995


St. Jude Medical, Inc


Research and Development


Manager of Catheter Research and Development


He was responsible for the development of a new line of diagnostic and therapeutic invasive cardiology catheter products including electronic instrumentation. He successfully managed all aspects of new product development from concept through market research, product definition, feasibility demonstration, pilot manufacture, animal and human testing, and regulatory approvals (510k and IDE). He actively directed the development of multiple cardiovascular products: a stopcock manifold, introducer/sheath, angiography catheter, guiding catheter, ablation guidewire, and coronary stent. The job required good communication skills and interaction with medical professionals, academic and industrial researchers, and all departments within St. Jude Medical. Reported directly to the Vice President of Technology.

1982 to 1988


Abbott Laboratories


Critical Care Division


Senior Product Engineer


He was involved in all engineering aspects of Abbott's critical care catheter product line: thermodilution catheters, multi-lumen central venous catheters, single lumen specialty intravenous catheters, introducers and needles. Technical duties included the initial development and testing of new catheter products; the design and quality of injection and insert molded components; the selection of materials and vendors; the development, documentation, and validation of assembly and sterile packaging processes and equipment; and major responsibility for quality, reliability, and safety of all catheter products. The job position required considerable interaction with Marketing, R&D, Quality, Accounting and Manufacturing.

Career Accomplishments:

Rotary International "Service above Self" award recipient, 2010

Publications and Patents Summary

He has 20 US patents/patents pending.

Government Experience:
Years   Agency   Role   Description
2001 to 2010   City of Northfield   City Councilor   In 9 years as city councilor, he was responsible for for all facets of city government including police, fire, roads, library, recreation, water, sewer, and civil rights for a community of 17,000. Responsible to create and manage a $40 MM annual budget.

Consulting Services:
Selected Consulting Examples:
  • He worked with physician entrepreneur to create a medical device company. He established the facility and hired first employees. He led the product design, fabrication, testing, and documentation through initial animal studies. Company was recently sold for $75MM.
  • He worked with entrepreneur with initial concept for a snoring relief implant device. He established the product requirements, designed initial prototype device and disposable implant tool through initial animal studies. Company was sold for $50MM.
  • Based on a "napkin sketch", he worked with a small medical device company to design and build an X-ray radiating intra-vascular catheter and associated instrument. He established product requirements, identified a key instrument design firm, and led the product development effort. Company was sold for $50 MM
  • He worked with a small medical device company to help conceptualize, design, and fabricate a neurovascular guidewire to remove blood clots from cerebral arteries to minimize or prevent brain damage due to stroke.
  • Working with the inventor, he provided key design elements to transform a crude concept for an intravascular filter into a working device that was designed for manufacturability and ease of use. The product design is the basis for a successful medical device company.
Recent Client Requests:
  • Expert in Medical Devices Forum
  • Medical instrument expert for consulting on Medical Grade Heat Shrinkable Tubing.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert in implantible pacemakers &Cardiac Defibrilators for "False Claims Act" case.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2000 to 2001   Schenzen, China   He established a state of the art angioplasty catheter medical device facility for clients in Hong Kong. In 11 months (4 months on-site in Schenzen) he led the design and mfg. start-up culminating in ISO facility approval and products CE mark.
2005 to 2005   Italy   He worked with a large Italian medical device molding company to transfer a medical device product developed by him in the US for manufacture in Italy.

Additional Skills and Services:
Supplier and Vendor Location and Selection

He has been sourcing disposable medical device materials and related services for over 20 years and has significant experience developing product specifications and requirements testing.

Other Skills and Services

He has significant experience reviewing and writing patent applications.


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