Expert Details
Medical Device Design and Manufacture
ID: 724264
Minnesota, USA
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 MMHe 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.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1980 | Degree: BA | Subject: Liberal Arts | Institution: University of St. Thomas |
| Year: 1980 | Degree: BS | Subject: Mechanical Engineering | Institution: Washington University |
| Year: 1987 | Degree: MEA | Subject: Engineering Management | Institution: University of Utah |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1995 to Present | Employer: Undisclosed | Title: Consultant | Department: |
Responsibilities: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.He also can support medical device start-up efforts. Raising capital, Conceiving design, Fabricating product, Conducting animal studies, Prosecuting IP, Developing marketing plan. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1995 | Employer: St. Jude Medical, Inc | Title: Manager of Catheter Research and Development | Department: Research and Development |
Responsibilities: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. |
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| Years | Employer | Title | Department |
| Years: 1982 to 1988 | Employer: Abbott Laboratories | Title: Senior Product Engineer | Department: Critical Care Division |
Responsibilities: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. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2001 to 2010 | Agency: City of Northfield | Role: City Councilor | Description: 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. |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2000 to 2001 | Country / Region: Schenzen, China | Summary: 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. |
| Years: 2005 to 2005 | Country / Region: Italy | Summary: 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. |
Career Accomplishments
| Awards / Recognition |
|---|
| Rotary International "Service above Self" award recipient |
| Publications and Patents Summary |
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| He has 20 US patents/patents pending. |
Additional Experience
| Vendor 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 Relevant Experience |
|---|
| He has significant experience reviewing and writing patent applications. |
Fields of Expertise
disposable medical device, medical device design, medical device product development, medical device evaluation, mechanical engineering analysis, package design, mechanical integrity, biocompatibility testing, Current Good Manufacturing Practice, cannula, medical device inspection, medical product manufacturing, plastic medical device, CE Marking, investigational medical device exemption regulation, medical device packaging standard, medical device packaging material, medical device safety, hemostat, dilator, 510(k) document, therapeutic device, medical device hazard analysis, stent, medical device product improvement, medical device manufacturing troubleshooting, cost reduction, biomedical device design review, biocompatibility, electronic medical device design, medical device process validation, medical device packaging process, medical device packaging design, medical device manufacturing, fault tree analysis, cost, needle, medical product, electronic medical device, biomedical device, packaging material, surgical instrument, medical device, FDA medical device regulation, implantable device, failure modes and effects analysis, endoscope, biomedical engineering