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 Expert  726891

Expert in International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance

Available for your Consulting and Expert Witness Needs

Wisconsin (WI)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're looking to obtain market clearance for one device, or you want to implement a complete regulatory compliance system for a start-up company, he can help.

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

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.


medical device product development


medical equipment


disposable medical device


medical device hazard analysis

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois;  Rockford, Illinois;  Aurora, Illinois;  Naperville, Illinois;  Elgin, Illinois;  Waukegan, Illinois;  Milwaukee, Wisconsin;  Madison, Wisconsin;  Green Bay, Wisconsin;  and Kenosha, Wisconsin.

Often requested
with this expert:

Biotechnology Product Reviews, Biologics, Drugs & Medical...
Medical Device Regulatory Support, Medical Device...
Medical Device Product Commercialization from R&D to...
Professional QA & Regulatory Compliance for Medical...

Year   Degree   Subject   Institution   Honors
1983   BS   Mechanical Engineering   UW Madison   Honors and distinction

Work History:
Years   Employer   Department   Title   Responsibilities

2009 to


Expert's Firm



Principal Consultant


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.

1999 to 2008


Ad-Tech Medical Instrument Corporation



Chief Operating Officer


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.

1994 to 1999


Stoelting Company


Autogenics & Pioneer Electric


Division Manager


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.

1991 to 1994


Telectronic Pacing Systems



Int'l Market Manager / Product Manager / Sales Rep


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.

1985 to 1991


Birtcher Corporation



Product Manager / Project Engineer / Production Manager


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.

Career Accomplishments:

Eagle Scout

Publications and Patents Summary

Expert has 1 patent with 2 more patents pending.

Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Medical device sales expert for consulting on Class I Device Sales & Marketing needed...
  • Durable medical supply expert for consulting on Leg Bag Release System & Floor Toliet.
  • Expert for consulting on Need to draft and help implement GMP and QA programs...
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:
  • FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
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:
Country / Region   Summary
Europe   Business Plan creation, ISO 13485 system creation, FDA regulatory compliance, product design and development.
Latin America   Business Plan creation, ISO 13485 system creation, FDA regulatory compliance, product design and development.
Asia   Devive distribution, distributor evaluation.

Market Research:
Expert has in-depth experience in international medical device trends, especially for neurosurgery and neurological devices, with an emphasis on epilepsy.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:

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.


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