Expert Details
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
ID: 728303
California, USA
Accomplished Senior Executive with broad wingspan and extensive domain experience
• CEO of 6 companies – public and private – in 5 countries
• Member of Board of Directors of 13 companies, including Chairman of the Board of 6 companies
• Broad domain experience including Class III implantable medical devices (cochlear implants, pacemakers & leads, ICD, neuromodulation, LVADs), imaging (ultrasound, X-ray), in vitro diagnostics, software, patient monitoring
Savvy Financial Manager
• Raised capital (public and private) >$200M. IPO on Euronext Paris and ESM Dublin
• Built revenues from zero to $30M annual run rate in 3 years with complex new product
• P&L responsibility from small to >$30M annual expenditure budget
• Sold three companies, participated in the sale of three others
Acknowledged leader and change agent
• Proven team leader from a small start-up to a 160-person public company. Effective mentor.
• Turned around and revitalized struggling company (three times)
• Drove culture change from local to global; from science to market; and from development to profit
Creative Contributor with a strategic view
• Inventor or co-inventor on >35 patents and applications, and built intellectual property portfolio of several companies
• Many peer-reviewed scientific publications
• Designed and conducted clinical trials for US (FDA) and European (CE Mark) approval of many medical devices
• Developed and implemented successful global sales and marketing strategies
He is an expert in the areas of general and specific management of a medical device or diagnostics company. His primary education is biomedical engineering and is an inventor on 36 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 the USA and divides his time between a home in France and a home in the US.
Expert has been responsible for the management of the intellectual property portfolio of several companies and is an expert on the 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.
Managing Partner of a biomedical business for 20 years.
Several clients worldwide (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.
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 |
|---|---|---|---|
| Years: 1995 to Present | Employer: Undisclosed | Title: CEO and Managing Partner | Department: |
Responsibilities:A consulting and advisory service in the medical device industry, including board services and expert witness work. |
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| Years | Employer | Title | Department |
| Years: 2018 to Present | Employer: Undisclosed | Title: Innovation Advisor | Department: |
Responsibilities:Provide guidance and advice to early-stage companies in the Wayfinder Seed Program (incubator).Unpaid work. |
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| Years | Employer | Title | Department |
| Years: 2009 to 2017 | Employer: Mainstay Medical | Title: CEO and Member of Board of Directors | Department: |
Responsibilities:A medical device company in the field of neurostimulation therapy for chronic low back pain.Worked for sweat equity refining ideas and raising capital with a $6M+ Series A financing in 2010. Built the company, recruited key team, designed Feasibility Clinical Study with encouraging results. Closed over-subscribed $20M Series B financing in September 2012 and led the move of the Company’s HQ from Minneapolis to Ireland. Led successful IPO in April 2014, with a dual listing on Euronext Paris and ESM of Irish Stock Exchange. Closed €30M private placement in June 2016. Designed ReActiv8-A clinical trial, which led to CE Marking approval in June 2016 and commercialization in 2017. Designed ReActiv8-B Clinical Trial, which gained IDE approval in May 2015. Planned retirement as CEO in October 2017. The Mainstay Device (ReActiv8) gained PMA approval in June 2020 |
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| Years | Employer | Title | Department |
| Years: 2005 to 2009 | Employer: Ventracor | 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 management aspects, including raising capital (>$60M in two rounds), building the team, strategy, corporate finance, corporate governance, market development, clinical trial design and execution, and business development. |
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| Years | Employer | Title | Department |
| Years: 1999 to 2005 | Employer: Ischemia Technologies Inc. | Title: CEO and Member of Board of Directors | Department: |
Responsibilities:A VC-backed company 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 financing rounds, oversaw product development, clinical trial design and execution, manufacturing start-up, quality systems, sales, and marketing. The product was introduced into the US and Europe, and revenues saw early growth before being sold to Inverness Medical Innovations. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1997 | Employer: NeoVision Corporation | Title: CEO and Member of Board of Directors | Department: |
Responsibilities:A medical device company commercializes a new product with 3D ultrasound image guidance of minimally invasive breast biopsies for suspected breast cancer. Joined as a consultant in early 2006 and later appointed as president and CEO. Obtained 2 term sheets for VC financing but sold the company to US Surgical for $42 million, yielding a >4x return to shareholders in approximately 18 months. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2006 | Employer: CardioComm Solutions, Inc | Title: Chairman of the Board and CEO | Department: |
Responsibilities:A Canadian public software development company with products for the management of real-time ECG and patient data.Joined as member of Board of Directors then became interim President & CEO. Cut costs and turned around the company, restructured management team raised new equity financing. Brought in new CEO and management team in 1999. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1995 | Employer: Telectronics Pacing Systems | Title: Various Vice President roles | Department: |
Responsibilities:A $200+ million global company in implantable cardiac pacemakers and defibrillators. Sold to St. Jude Medical in 1996. Several VP riles in strategy, Research and Technology, and International Marketing.VP Business Development Led the development of the overall business strategy; strategic alliances; diversification and consolidation opportunities; coordination with potential investors; and management of the intellectual property portfolio. VP Research & Technology Managed applied research and technology of pacemakers and leads, including IC design, applied research, and biomaterials. Managed patent portfolio and negotiated to cross licensing. Managed two major product recalls. VP Strategic Planning Responsibility for planning: product strategy, diversification opportunities, and company structure. Organized customer focus groups and Scientific Advisory Board and developed the strategic plan. VP International Marketing Coordinated global product marketing strategies for regions outside the USA. Created sales strategies and provide sales support to sales reps and customers. VP Tachycardia Global project management function, responsible for product development, clinical trial, regulatory strategy, and market launch for the emerging implantable defibrillator business. Forged relationships between the R&D group and customers in major markets. Presented to FDA PMA panel meeting. |
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| Years | Employer | Title | Department |
| Years: 1986 to 1989 | Employer: Ausonics Pty. Ltd | 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 company's viability during a time of cash squeeze, revitalized manufacturing and marketing, removed unprofitable products, improved sales of core products, and cleaned up the balance sheet. In addition, negotiated contracts with a Japanese supplier of equipment for U.S. distribution and negotiated to sell the U.S. mammography distribution business. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1986 | Employer: Cochlear Corporation | Title: R and 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 the University of Melbourne for technology transfer. Developed speech processor and speech processor programming system for a cochlear implant. Wrote patents, physician manuals, user manuals, and part of PMA regulatory submissions. |
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| Years | Employer | Title | Department |
| 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), responsible for procurement and maintenance of medical technology equipment for all departments. In addition, designed and built custom instrumentation for numerous research projects for several specialties. |
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| Years | Employer | Title | Department |
| 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. |
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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 |
| Professional Appointments |
|---|
| Executive Chairman- ClinNEXUS Inc. Executive Chairman- CenSyn Inc. Executive Chairman - Docbot Inc. Chairman of the Boards of Directors - SimTutor, Inc. Member of Board of Directors - Quench Medical Chairman of the Board - First Medical Member of the Board, Chairman of Audit Committee - Cardiac Science Chairman, Medical Devices Advisory Board - MDS Capital Corp. and CMDF |
| Publications and Patents Summary |
|---|
| Dozens of publications in the medical device field as the author or contributing author. He is the inventor on 36 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 the treatment of back pain, implantable RF ablation system, and methods of use Apparatus and methods for rehabilitating a muscle and assessing the progress of rehabilitation Apparatus and methods for anchoring electrode lead for use with an 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 an 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 an 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, Civil Action • A Civil Division– primarily related to “commercially reasonable efforts.” • 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 Many more examples are available upon request. |
| Training / Seminars |
|---|
| He has delivered many training courses and seminars, primarily in medical device risk management, recall management, prevention of lawsuits, quality assurance, and product design. Education: M Eng Science, B Engineering (University of Melbourne, AU). Graduate of AICD Company Directors course. |
| 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 the management of medical device recalls. Dual citizenship: USA and Australia |
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