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 Expert  728193

Expert in Medical Device Product Commercialization from R&D to Manufacturing, Regulatory and Clinical Trials

Available for your Consulting and Expert Witness Needs

California (CA)
Education Work History Career Accomplishments Consulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control; from Food and Drug Administration medical device regulation and submissions such as 510(k)s documents to medical device clinical research; from medical device product introduction to technical support, including medical device evaluation, hazard analysis and product recall management. Expert's activities have included medical device development for Fortune 50 companies such as General Electric (e.g. GE Medical Systems, Johnson and Johnson), numerous early stage companies (e.g. Ventracor) and growth companies (e.g. Cardiac Science)

Expert is currently an independent consultant as founder of his own consulting firm. In this capacity, he has led due diligence and consulting projects with medical device companies and their investors in the areas of regulatory strategy, medical device evaluation, medical device product development, medical device manufacturing and medical device field corrective actions and recalls. In addition, he has served as project manager for large new product development projects for companies such as General Electric and Johnson and Johnson.

As COO of Ventracor, Expert was responsible for the company's product development, global manufacturing, quality assurance, regulatory affairs, and clinical research. In this capacity, he interacted closely with the US Food and Drug Administration and obtained unconditional approval for the company's clinical trials under Investigational Device Exemption (IDE). Under his leadership, the company fully enrolled the trial in approximately one year, establishing the foundation for a Pre-Market Approval (PMA) from the US Food and Drug Administration.

While Senior Vice President of Operations at Cardiac Science, Expert led the company's rapid growth from a start-up to a $180 M/year company in the areas of global manufacturing and quality assurance, regulatory affairs, technical support, and clinical research functions. He served as the company's main interface with the US Food and Drug Administration for product recalls and audits, improving the company's quality control system and re-establishing the company's credibility with the US Food and Drug Administration in the areas of quality system regulation, 510(k) product submission and product recalls. His activities in global manufacturing led to a 50% reduction of the company's defibrillators cost of goods, while simultaneously improving product quality, receiving a supplier quality score from General Electric in the top 10 percentile and improving the products' first-pass manufacturing yield to over 99%.

Prior to Cardiac Science, Expert was Manager of X-Ray Imaging Engineering at GE Medical Systems (now GE Healthcare), where he was responsible for the development and manufacturing transfer of new X-Ray imaging products. In that capacity, he introduced numerous new X-Ray Imaging products to manufacturing under GE's new "Design for Six Sigma" process. He also worked with a large number of GE medical Systems' smaller technology providers to help them improve quality systems and product development processes.

Expert is an excellent team builder and communicator. He is fluent in 3 languages (English, Dutch and French) and was the recipient of a Fullbright Scholarship. He was elected member of the honor societies of Phi Kappa Phi, Sigma Xi and Eta Kappa Nu and has a Ph.D. in Acoustics engineering from Pennsylvania State University.


FDA medical device regulation


medical device


medical device manufacturing


medical device manufacturing quality control


510(k) document


medical device clinical research


medical device product development


investigational medical device exemption regulation


medical device premarket approval

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California;  San Diego, California;  Long Beach, California;  Santa Ana, California;  Anaheim, California;  Riverside, California;  Glendale, California;  Huntington Beach, California;  San Bernardino, California;  and Chula Vista, California.

Often requested
with this expert:

Medical Devices; Product Development, Manufacturing,...
Medical Device Software, Medical Device Software...
Implantable and Non-Implantable Medical Device Risk,...
Medical Device Regulatory Support, Medical Device...

Year   Degree   Subject   Institution   Honors
1983   Ph.D.   Acoustics Engineering   The Pennsylvania State University  
1978   MS   Electrical Engineering   IHAM, Antwerp, Belgium   Magna Cum Laude
1977   BS   Electrical Engineering   SIHTS, Antwerp, Belgium   Magna Cum Laude

Work History:
Years   Employer   Title   Responsibilities

2004 to




Managing Member


He is founder and principal consultant to medical device investors and companies.

2007 to 2008


Ventracor, Inc.




He was responsible for the company's global Manufacturing and Sourcing, Quality Assurance, Regulatory Affairs, Clinical Research, Product Development, R&D and information technology.

2000 to 2004


Cardiac Science, Inc.


CTO; Senior Vice President; Managing Director, Artema Medical AB; General Manager, Troniqa


He led the company's Manufacturing and Sourcing, Quality Assurance, Regulatory Affairs, Clinical Research, Technical Support and Customer Support functions. Additionally, he was responsible for pre-due diligence, due diligence and acquisition integration activities for the company's M&A activity.

1995 to 1997


General Electric Medical Systems


Manager, X-Ray Imaging Engineering


He led the development and manufacturing transfer of new X-Ray imaging subsystems and components.

1989 to 1995


General Electric Corporate Research and Development Center




He developed advanced image and signal processing technology for GE's operating divisions; in particular GE Medical Systems and GE Aerospace.

Career Accomplishments:

Fullbright scholar, 1978-1983; Member of the honor societies of Eta Kappa Nu, Sigma Xi and Phi Kappa Phi

Consulting Services:
Selected Consulting Examples:
  • Client company, a medical device company in a rapid growth phase, had received a warning letter from FDA after an audit. FDA ruled it had not received satisfactory response from Company and was preparing more serious action. After investigating specific product issues that lead to warning letter, he restored client's credibility with the FDA by (1) implementing continuous improvement plan for the client's quality system that addressed FDA's findings (2) helping client develop and implement a product recall plan and (3) executing a clear communication strategy with the FDA. As a result, the client passed the FDA's follow-on audit.
  • Client class II and class III medical device company was about to invest significant capital (>$50M) in the production of a new product and wanted an external evaluation of the product before giving a go-ahead. After evaluating the product development process, he uncovered significant gaps in the verification and validation of the design. He also highlighted serious issues with the client's product development process, which could have exposed the company to detrimental action by regulators. He helped the company correct these issues and avoid a large investment mistake as well as exposure to regulatory action by FDA.
  • Client class III medical device company was interested in acquiring a competitor. During the due diligence phase, he uncovered that the company to be acquired had significant issues in its quality system, and that a new product soon to be released posed a significant risk. As a result, the client company decided not to proceed with the acquisition, avoiding significant product problems and ultimately legal issues, as the competitor struggled with a large-scale recall.
Recent Client Requests:
  • Expert in Writing a 510K.
  • Medical device regulatory and development.
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:
Expert Witness Experience Summary:
As corporate employee, served as witness in one jury trial (employee lawsuit) and was deposed in one product liability case (Cardiac Science).
Recent Litigation Client Requests:
  • Expert surgical staple guns for consulting on product liability.
  • Expert in Litigation, burn at grounding pad site.
  • 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:
Years   Country / Region   Summary
2004 to 2005   Scotland   He was a global project manager for a major new product development project for a major medical device manufacturer. The project spanned the United Kingdom, Italy, China, Singapore and the U.S.
2007 to 2008   Australia   He was COO for a global medical device manufacturer with a presence in Australia, the Netherlands, and the U.S.
1995 to 1997   France   He was a manager for a major medical systems manufacturer located in France

Language Skills:
Foreign Language   Description
Dutch   He is fluent in Dutch, which is his native language
French   He is fluent in French, as he was born and raised in Belgium (bi-lingual country) and lived in France for 3 years.
German   He was born and raised in Belgium and traveled extensively in Europe.

Market Research:
21 years experience working with a broad spectrum of medical device companies and their new product introduction strategies has positioned him with unique insight on global medical device regulatory trends.

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:

Quality College -- continuous improvement of quality systems and processes (Cardiac Science) Cycle Time Reduction (LEAN) -- continuous improvement of end-to-end product development and introduction processes

Supplier and Vendor Location and Selection

Established global supply chain initiative (Singapore, Malaysia, China) for Cardiac Science, resulting in 50% cost of goods reduction. Global project management for new product development spanning U.S., Singapore, China, United Kingdom, Italy for Johnson & Johnson

Other Skills and Services

Due diligence, financing for early-phase medical device companies.


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