Expert Details

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business practices, IP, commercial contracts, finance, M&A

Expert ID: 728303 Minnesota, USA

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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 areas of general and specific management of a medical device or diagnostics company. His primary education is biomedical engineering, and is an inventor on about 30 US patents, 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, strategic partnerships and M&A, marketing, sales, corporate governance and corporate finance.

He has introduced dozens of new and innovative medical devices to world markets, and is familiar 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.

Expert has been responsible for management of the intellectual property portfolio of several companies, and is expert on development and protection of an IP portfolio, as well as prosecution of patents in multiple jurisdictions. He has participated in several intellectual property disputes and served as an expert on several occasions. He is an inventor on 30 issued US patents.

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. Expert in Residence at the Wayfinder Incubator at the University of California, Irvine.

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 - Chula Vista, California

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Education

Year Degree Subject Institution
Year: 1976 Degree: Master Engineering Science Subject: Biomedical Engineering Institution: University of Melbourne, Australia
Year: 1974 Degree: Bachelor Engineering Subject: Electronics Institution: University of Melbourne, Australia

Work History

Years Employer Title Department Responsibilities
Years: 2009 to 2017 Employer: (Undisclosed) Title: CEO and Director Department: Responsibilities: the founding CEO. Series A financing was closed in July 2010, Series B in 2012, and he took the company 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.
Years: 2005 to 2009 Employer: (Undisclosed) Title: CEO And Managing Director Department: Responsibilities: 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.
Years: 1989 to 2005 Employer: Ischemia Technologies Inc. Title: Chief Executive Officer & Director Department: Responsibilities: 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, he was instrumental in managing several major product recalls, including presenting to the FDA, and later acting as expert witness in several product liability lawsuits.
Years: 1999 to 2004 Employer: (Undisclosed) Title: CEO and Director Department: Responsibilities: A 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.
Years: 1998 to 2000 Employer: CardioComm Solutions, Inc Title: Chairman of the Board Department: Responsibilities: 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. Was sold for $33M.
Years: 1996 to 1997 Employer: (Undisclosed) Title: CEO and Director Department: Responsibilities: Was developing and commercializing a device for three dimensional ultrasound image guidance of minimally invasive breast biopsy.
He reinvigorated the company after running out of capital, saw the product through regulatory approval and market launch.
Years: 1986 to 1989 Employer: (Undisclosed) Title: CEO and Director Department: Responsibilities: Was a manufacturer and distributor of hand held ultrasound imaging equipment and was a distributor of low dose X-ray mammography equipment. As CEO, he was responsible for all aspects of the business, including product strategy and development, oversight of manufacturing and quality systems, and sales and marketing.
Years: 1981 to 1986 Employer: Telectronics Pacing Systems Title: Various roles Department: Responsibilities: 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.
Years: 1995 to Present Employer: Undisclosed Title: Managing Partner Department: Responsibilities: Biomedical Business Resources provides consulting and advisory services in the medical device industry, including expert witness work.
Years: 1986 to 1989 Employer: (Undisclosed) Title: Chief Executive Officer & Director Department: Responsibilities: A $30M revenue public company subsidiary that developed, manufactured, and distributed ultrasound imaging
equipment. US distributor of OEM-sourced X-ray mammography equipment.
Joined as Chief Executive R&D in 1986, promoted to CEO in 1987. Turned around and maintained the viability of the
company during a time of cash squeeze, revitalized manufacturing and marketing, removed unprofitable products,
improved sales of core products, and cleaned up balance sheet. Negotiated contracts with a Japanese supplier of equipment for U.S. distribution and negotiated to sell the U.S. mammography distribution business.
Years: 1981 to 1986 Employer: Cochlear Corporation Title: R&D Executive Department: Responsibilities: World leader in implantable hearing prostheses, dominant market share, major public company.
One of the founding team. Several positions held in product development, marketing, and manufacturing. Liaised with
University of Melbourne for technology transfer. Developed speech processor and speech processor programming system for cochlear implant. Wrote patents, physician manuals, user manuals, and part of PMA regulatory submissions.
Years: 1978 to 1981 Employer: Northern Region Biomedical Engineering Service Title: Director Department: Responsibilities: Established and managed a Biomedical Engineering Service at a major teaching hospital at the center of a health care
region (approx. 3000 beds), with responsibility for procurement and maintenance of medical technology equipment for all
departments. Designed and built custom instrumentation for numerous research projects for several specialties.
Years: 1976 to 1978 Employer: Sydney Eye Hospital Title: Researcher Department: Responsibilities: Designed and built equipment for the new laboratory for the founding Professor of Ophthalmology including visual evoked
potentials, electroretinography, and electrooculography. Participated in several clinics, and ran training programs for ophthalmology fellows in various topics including vitrectomy, ophthalmic electrophysiology, and intraocular lenses.

International Experience

Years Country / Region Summary
Years: 1981 to 1989 Country / Region: Australia Summary: Worked in several companies in the Nucles Group (Sydney, Australia), including one of the first team of Cochlear, and CEO of Ausonics.
Years: 1997 to 2006 Country / Region: Canada Summary: 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.
Years: 1985 to 2017 Country / Region: Europe Summary: 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.
Years: 2012 to 2017 Country / Region: Ireland Summary: 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.

Career Accomplishments

Associations / Societies
Fellow of Australian Institute of Company Directors (FAICD)
Past member of IEEE
Publications and Patents Summary
Dozens of publications in the medical device field as author or contributing author.

He is the inventor on 30 US patents - primarily in the field of medical devices.
Systems and Methods for Restoring Muscle Function to the Lumbar Spine
Apparatus and Methods for Anchoring Electrode Leads Adjacent to Nervous Tissue
Systems and methods for restoring muscle function to the lumbar spine and kits for implanting the same
Electrical Stimulator for Treatment of Back Pain and Methods of Use
Systems and methods for restoring muscle function to the lumbar spine
Modular stimulator for treatment of back pain, implantable RF ablation system and methods of use
Apparatus and methods for rehabilitating a muscle and assessing progress of rehabilitation
Apparatus and methods for anchoring electrode leads for use with implantable neuromuscular electrical stimulator
Systems and methods for restoring muscle function to the lumbar spine
Blood pump with an ultrasound transducer
Implantable medical devices
Apparatus and method for risk stratification of patients with chest pain of suspected cardiac origin
Electrochemical detection of ischemia
Bar code readable diagnostic strip test
Devices for testing fluid
Methods and apparatus for therapeutic cauterization of predetermined volumes of biological tissue
Apparatus and method for securing tissue during ultrasound examination and biopsy
Traction-inducing compression assembly for enhanced tissue imaging
Sonography and biopsy apparatus
Myostimulator control using metabolic demand and muscle performance
Cardiac stimulation system with enhanced communication and control capability
Cardiomyoplasty simulator with feedback control
Automatic atrial pacing pulse threshold determination utilizing an external programmer and a V-sense electrode
Automatic atrial pacing threshold determination utilizing an external programmer and a surface electrogram
Automatic Ventricular pacing threshold determination utilizing an external programmer and a surface electrocardiogram
Facsimile machine for printing documents all with corresponding edges aligned but without requiring scanning
Physiologically-calibrated rate adaptive, dual chamber pacemaker
Cochlear implant system for an auditory prosthesis
Cochlear prosthesis test system

Additional Experience

Expert Witness Experience
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.Key cases include:
Worked with many law firms as an expert witness in the general areas of medical device product liability, medical device intellectual property, and contract disputes. Work included affidavits, depositions, and court appearances. Cases include:
• A major intellectual property case in the mid-1990s involving patents regarding implantable defibrillators
• A patent dispute case in 2004 involving Ischemia Technologies where the inventor of the patent on which the company was founded filed another patent and licensed it to a competitor, for Ischemia Technologies.
• A case involving an IP dispute between Sigma and Carefusion (Plaintiff) in the District Court for the Southern District of California, Civil Action
• A matter between Stryker Corp. and Joseph P. Errico, et al. in the Circuit Court for Kalamazoo County, Civil Division– primarily related to “commercially reasonable efforts,” for Stryker.
• A matter between Bausch and Lomb and Dr. Sarfarazi (New York Western District – primarily related to “commercially reasonable efforts” for Bausch and Lomb.
• A matter between two medical device companies relating to commercially reasonable efforts to achieve milestones following an M&A transaction (American Arbitration Association)
• Multiple product liability cases (for the defendant), including expert reports, depositions, and court appearances
Training / Seminars
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.
Vendor Selection
Worked with global vendors - US, Japan, China, Europe.
Marketing Experience
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.
Other Relevant Experience
Extensive international experience and extensive experience in management of medical device recalls

Language Skills

Language Proficiency
English Primary Language (Mother tongue)
French Moderate proficiency; not fluent.

Fields of Expertise

510(k) document, artificial cardiac pacemaker, biomedical device, biomedical device manufacturing, CE Marking, clinical protocol, clinical trial, clinical trial design, defibrillator, 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, intellectual property, neuromodulation, medical liability, In Vitro Diagnostics Directive 98/79/EC, medical device market research, hermeticity testing, Safe Medical Devices Act of 1990, Food and Drug Administration compliance, medical software quality assurance, Current Good Manufacturing Practice, transcutaneous electrical nerve stimulator, Medical Device Reporting regulation, medical product manufacturing, medical device auditing, in vitro diagnostics Food and Drug Administration code, medical device safety, medical device manufacture clean room, governmental registration process, medical device hazard analysis, medical technology, medical device manufacturing troubleshooting, medical device manufacturing automation, medical malpractice evaluation, biomedical device design review, medical device reliability testing, medical product, prosthesis, medical equipment, medical electronics science, Good Manufacturing Practice

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