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 Expert  728303

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP

Available for your Consulting and Expert Witness Needs

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

Summary of Expertise: Listed with other top experts in: 
Expert has been the CEO or chairman of 7 medical device companies in 4 countries - 4 public, 3 private, and has been a member of the Board of Directors of 8 companies. He is an expert in all areas of general and specific management of a medical device or diagnostics company. His primary education is biomedical engineering, and he has about 25 patents to his name, primarily in the medical device field.

Primary clinical areas of specialty include cardiology and cardiac surgery (implantable pacemakers and defibrillators and leads, left ventricular assist devices, diagnostic tools and monitors), neuromodulation and sensory prostheses (cochlear implants, muscle stimulators, pain), in vitro diagnostics, ultrasound imaging, and general biomedical engineering.

His business function expertise includes research and development, clinical trial design and conduct, quality system, manufacturing, regulatory approvals and compliance, marketing, sales, corporate governance and corporate finance.

Expert has introduced dozens of new and innovative medical devices to world markets, and is familair with the challenges of cross cultural business integration. He is a dual citizen of Australia and USA, and divides his time between a home in France and a home in the US.


510(k) document


artificial cardiac pacemaker


biomedical device


biomedical device manufacturing


CE Marking


clinical protocol


clinical trial


clinical trial design




disposable medical device


electronic medical device


electronic medical device design


Food and Drug Administration


FDA medical device regulation


foreign medical device regulation


implantable device


in vitro diagnostics


investigational medical device exemption regulation


medical device


medical device clinical research


medical device design


medical device evaluation


medical device liability


medical device manufacturing


medical device manufacturing quality control


medical device premarket approval


medical device product development


medical device product improvement


medical device reporting


nerve stimulator


therapeutic device


cochlear implant


cochlear implantation

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 Product Commercialization from R&D to...
Implantable and Non-Implantable Medical Device Risk,...
Medical Device Total Quality
Electrical and Biomedical Engineering, Patent Analysis,...

Year   Degree   Subject   Institution   Honors
1976   Master Engineering Science   Biomedical Engineering   University of Melbourne, Australia  
1974   Bachelor Engineering   Electronics   University of Melbourne, Australia   Second in faculty of several hundred

Work History:
Years   Employer   Title   Responsibilities

2009 to






Expert is the founding CEO. Series A financing was closed in July 2010, Series B in 2012, and the company went public in Europe in 2014. Responsibilities include building the team, strategy, clinical trial design and execution, product procurement, regulatory approvals and market development, and raising capital.

2005 to 2009


Ventracor Limited


CEO And Managing Director


Ventracor was an Australian public company developing and commercializing the VentrAssist implantable left ventricular device (LVAD) - a blood pump for patients in end stage heart failure. He was responsible for all aspects of management, including raising capital (>$60M in two rounds), building the team, strategy, corporate finance and corporate governance, market development, clinical trial design and execution, and business development.

1989 to 2005


Telectronics Pacing Systems


Various VP Positioms


Telectronics Pacing Systems was a global manufacturer and marketer of implantable cardiac pacemakers and defibrillators. Expert held positions of VP Tachycardia Business, VP International Marketing, VP Strategic Planning, VP Research and Technology, and VP Business Development. He was involved in bringing many new products to market. During his tenure, Expert was instrumental in managing several major product recalls, including presenting to the FDA, and later acting as expert witness in several product liability lawsuits.

1999 to 2004


Ischemia Technologies




Ischemia Technologies was developing and commercializing a new in vitro diagnostic test for cardiac ischemia to help rule out heart attack in patients presenting to the hospital emergency room with chest pain of suspected cardiac origin. Expert was the founding CEO, raised four rounds of financing, oversaw product development, clinical trial design and execution, manufacturing start up, quality systems, sales and marketing. The product was introduced into US and Europe and revenues saw early growth before the company was sold to Inverness Medical Innovations.

1998 to 2000


First Medical


Chairman of the Board


First Medical was developing and commercializing a point of care immunoassay test for cardiac markers. After receiving $25M of investment from several VC firms, the company was unable to raise further capital. Expert arranged to buy the company for $100 from the investors, raised new capital, put in a new management team (including a new CEO), and oversaw the company's growth and corporate governance. First Medical was sold to Sigma Diagnostics for $33M.

1996 to 1997


NeoVision Inc




NeoVision was developing and commercializing a device for three dimensional ultrasound jmage guidance of minimally invasive breast biopsy. Expert reinvigorated the company after running out of capital, saw the product through regulatory approval and market launch. NeoVision was sold to US surgical in 1997.

1986 to 1989






Ausonics was a manufacturer and distributor of hand held ultrasound imaging equipment and was a distributor of low dose X-ray mammography equipment. As CEO, Expert was responsible for all aspects of the business, including product strategy and development, oversight of manufacturing and quality systems, and sales and marketing.

1981 to 1986




Various roles


Cochlear is the world leader (market Cap approximately $4Bn) of cochlear implants (implantable hearing prostheses). Expert was part of the founding team that transferred the technology from the University of Melbourne, and was responsible for all product development for elements outside the body, wrote key patents, wrote much of the PMA application, and was responsible for the early stages of international marketing.

Career Accomplishments:

Fellow of Australian Institute of Company Directors (FAICD)

Publications and Patents Summary

He has about 25 patents - primarily in the field of medical devices. Dozens of publications in the medical device field as author or contributing author.

Consulting Services:
Selected Consulting Examples:
  • Managing Partner of Biomedical Business Resources for 20 years.Several clients world wide (most prefer to remain confidential)
  • Helped a small New Zealand company negotiate with a much larger US company for an intellectual property licensing agreement on favorable terms.
  • Helped a biological vascular graft company with strategy development and an execution plan for business expansion.
  • Acted as an expert for a larger multinational medical device company in a dispute involving whether or not the company used "commercially reasonable efforts" to commercialize an inventor's idea.
  • Acted as an expert in an intellectual property dispute between two US medical device companies.
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:
He has acted as expert witness (depositions, expert reports and court appearances) for medical device product liability litigation, primarily in the field of implantable cardiac pacemakers, defibrillators, and leads. He has also acted as expert witness in several intellectual property lawsuits (including developing briefs for claims construction and Markman hearings). Also acted as an expert on suits involving disputes over "commercially reasonable practices" in the context of the medical device industry.
Recent Litigation Client Requests:
  • Clinical trial expert witness for consulting on clinical trial design and industry norms about clinical trial phases.
  • Expert in cardiac devices for consulting on post-mortem pacemaker evaluation.
  • Expert surgical staple guns for consulting on product liability.
  • Expert for consulting on defibrillator.
  • Expert in Litigation, burn at grounding pad site.
  • Cardiac electrophysiology expert witness for consulting on proper defibrillator (AED) maintenance.
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
to   Australia   He has served as CEO of two Australian medical device companies
to   Canada   He was CEO and then Chairman of the Board of a Canadian public company developing and selling software solutions for management of large amounts of ECG data for cardiologists.
to   Europe   He has introduced several new products into Europe, including obtaining CE Mark (or other regulatory approval) reimbursement, and developing a sales force or third part distributors.
to   Japan   Negotiated with Japanese OEM supplier of X-Ray mammography equipment. worked with Japanese Ministry of Health and Welfare on several new product introductions, and with several product recalls.
2012 to   Ireland   Moved US medical device company to Ireland and remained as CEO of the new Irish entity. Took the company public in Europe on ESM (Ireland) and Euronext (Paris) in 2014.

Language Skills:
Foreign Language   Description
English   Primary Language (Mother tongue)
French   Moderate proficiency; not fluent.
German   Basic (high school) level.

Market Research:
He is an expert in identifying trends in the medical device and diagnostics industry, particularly the impact of changes in legislation and regulations, technology developments, and economic conditions.

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 has delivered many training courses and seminars, primarily in the field of medical device risk management, recall management, prevention of lawsuits, quality assurance, and product design.

Supplier and Vendor Location and Selection

Worked with global vendors - US, Japan, China, Europe.

Other Skills and Services

Extensive international experience and extensive experience in management of medical device recalls


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