Expert Details
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
ID: 726891
Wisconsin, USA
Expert takes pride in the personal relationships he has nurtured over the years. If you need market insight from Europe, Asia or Latin America, he has been to the homes of the leading doctors and distributors. In addition, Expert can help with market and distribution analysis, domestic and international distribution channels, corporate image development, (including brochures, catalogs, price lists, business cards, etc.) and product positioning.
In addition, if you need help from technology evaluation, technical file/design dossier creation and ISO 14971 compliant risk analysis, to business plan and grant writing, Gantt scheduling and liaison coordination, Expert has the experience to help ensure a smooth and successful launch. He has performed these services over 40 times.
Expert has written numerous Business Plans for medical device start-ups. He has the ability to focus on industry trends and recognize hidden, but valuable, market positions. He can use his experience to help source components or complete systems, raise funds and provide distribution channels.He takes a very logical approach to the creation of quality systems. Having managed internal document control systems for several manufacturers, and created ISO 13485 systems from the ground-up, he knows "what works" in industry today. He can help clients build an efficient and compliant infrastructure. Expert has experience in helping clients "overcome" the FDA, CE/MDD, PAL, TGA, etc. He stresses that you should always do things legally, but if you are a physician with an idea - please don't talk with the FDA until you talk with a consultant. Often times, physicians emphasis the "novelty" of their idea that they box themselves into a corner when it comes time to seek regulatory compliance.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1983 | Degree: BS | Subject: Mechanical Engineering | Institution: UW Madison |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2009 to Present | Employer: Undisclosed | Title: Principal Consultant | Department: |
Responsibilities:This privately-held medical device consulting company focuses strategic business development for international and domestic partnerships. Emphasis is placed on 1) Sales, Marketing and Distribution, 2) Quality Systems and Regulatory Affairs, and 3) Project Management and Product Development. |
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| Years | Employer | Title | Department |
| Years: 1999 to 2008 | Employer: Ad-Tech Medical Instrument Corporation | Title: Chief Operating Officer | Department: |
Responsibilities:A privately-held company that is the world’s leading manufacturer of intracranial electrodes and accessories used primarily for the surgical treatment of epilepsy. Company sales are split with 65% domestic and 35% international.Responsible for the strategic and operating growth of the company and directed all functional areas except finance. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1999 | Employer: Stoelting Company | Title: Division Manager | Department: Autogenics & Pioneer Electric |
Responsibilities:A privately-held neuroscience-based, research instrument company.Responsible for new product design and development, sales and marketing and regulatory affairs for two divisions: Autogenics, a physiological monitoring division and Pioneer Electric & Research, an industrial test and measurement instrument division. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1994 | Employer: Telectronic Pacing Systems | Title: Int'l Market Manager / Product Manager / Sales Rep | Department: |
Responsibilities:A $200 million cardiac pacemaker company (subsidiary of a $6.2 billion conglomerate) with $150 million domestic and $50 million international sales.International Market Manager - Responsible for market and product development, and market liaison for bradycardia products. Product Manager - Responsible for the product planning and implementation of instruments and accessories. Independent Sales Representative - Responsible for sales in a three state territory. |
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| Years | Employer | Title | Department |
| Years: 1985 to 1991 | Employer: Birtcher Corporation | Title: Product Manager / Project Engineer / Production Manager | Department: |
Responsibilities:A $50 million publically-held medical device corporation.Product Manager - Managed five product lines in cardiovascular instruments, Doppler ultrasound, electrosurgery, Hyfrecator (dermatology-based electrosurgery), and physical therapy. Project Engineer - Design above-mentioned products. Production Manager - Built afore-mentioned products. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: to Present | Country / Region: Europe | Summary: Business Plan creation, ISO 13485 system creation, FDA regulatory compliance, product design and development. |
| Years: to Present | Country / Region: Latin America | Summary: Business Plan creation, ISO 13485 system creation, FDA regulatory compliance, product design and development. |
| Years: to Present | Country / Region: Asia | Summary: Devive distribution, distributor evaluation. |
Career Accomplishments
| Awards / Recognition |
|---|
| Eagle Scout |
| Publications and Patents Summary |
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| Expert has 1 patent with 2 more patents pending. |
Additional Experience
| Training / Seminars |
|---|
| He teaches Medical Device Physics for Allied Health Professional. The purpose of this class is to present the underlying laws of physics and engineering principles as they apply to medical devices. He also gives a six-hour lecture series presented for CME units. |
| Marketing Experience |
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| Expert has in-depth experience in international medical device trends, especially for neurosurgery and neurological devices, with an emphasis on epilepsy. |
Fields of Expertise
510(k) document, CE Marking, Current Good Manufacturing Practice, Food and Drug Administration, Food and Drug Administration compliance, FDA medical device regulation, foreign medical device regulation, Good Manufacturing Practice, medical device manufacturing quality control, medical device product development, medical equipment, disposable medical device, medical device hazard analysis, medical device evaluation, nerve stimulator, cannula, Medical Device Reporting regulation, medical device reporting, durable medical equipment, investigational medical device exemption regulation, hospital equipment, therapeutic device, medical technology, plastic product, international organization, electronic medical device design, medical device design, fault tree analysis, medical product, electronic medical device, device code, surgical instrument, artificial cardiac pacemaker, implantable device, failure modes and effects analysis, materials failure analysis, defibrillator