Overview:
  Experienced global leader in medical device innovation and business development with a proven record of
success in creating profitable new products for diagnostic markets. Known for unlocking the value in emerging
technologies, evaluating market potential, developing clinical evidence portfolios, and managing cross-functional
teams. Cited for ability to identify major issues and trends in financial and operating data, anticipating and
analyzing risks, making strategic choices, and developing and retaining individuals who can make critical
contributions to organizational success. Background includes a PhD from Northwestern University and an MPhil
from University of Cambridge (UK). Expatriate experience in global biotechnology and health care markets; at
ease working with diverse working teams and customers in international settings.

Areas of Expertise:
            General / Executive Management
            Strategic Market Assessment
            Medical Device Engineering
            Regulatory Compliance / FDA & CE Approvals
            Medical Informatics Standards And Systems
            Strategic Partnerships / Alliances
            Product Development
            Clinical and Experimental Trial Design
            Research / Technical Leadership
            Global Technology / Market Development
            Customer Relationship Management
            Scientific and Clinical Study Management
            Design Control / Process Development
            Intellectual Property
            Contract Negotiations
            Cross-functional, Cross-cultural Leadership

Career Highlights:
MEDTRONIC SUBCUTANEOUS DIAGNOSTICS AND MONITORING (SQDM)        Arnhem, NL
(Formerly Medtronic Vitatron. Developer of Reveal, an implanted medical diagnostic device for cardiac
monitoring of syncope, atrial arrhythmias, acute ischemic events, and heart failure)

DIRECTOR, SQDM SENIOR STAFF /  CORE BUSINESS LEAD, ACUTE CARE DIAGNOSTICS
Nov. 2006 to present
    Expatriate assignment to the Netherlands with three distinct areas of accountability: general management
    of $65 million (USD) business unit; business director for AMI / SCD device and market development;
    functional director for Research and Technology. Lead core team comprised of research scientists,
    product engineers, regulatory, quality, marketing, and clinical specialists.  

    Key Contributions:
            Grew global sales by 70% in FY ’07 with 80% gross margins, bringing the company to
    profitability in it’s second year of operations.
            Defined the market analysis and prototype development process for new Diagnostics and
    Alerting business. Guided development team that created an investigational implant for early
    detection of STEMI within eight months of feature definition, defining clinical strategy and creating
    evidence portfolio to allow research to move from product conception to first human implant within
    14 months of project start.
            Authored new research process which encourages innovation and technology transfer
    efficiency by defining procedures for early-stage projects (demonstration of feasibility) as distinct
    from late-stage projects (reduction-to-practice).  Maintains compliance with legal and agency
    requirements.
            Established contracts with vendors for co-development and licensing of enabling technology,
    and with clinical centers for experimental and patient studies negotiating publication and patent
    rights in each case. Recruited US and European physician advisory group, and led market and
    technology evaluation process to define customer use scenarios and factors driving adoption.



CAMSTENT LLC.        Cambridge, UK
(Startup – Biofilm-resistant coatings for medical, consumer, and marine applications)

CHAIRMAN AND CEO
2006 to Present
    Co-founded medical therapeutics company based on proprietary biofilm-resistant polymer. Wrote and
    presented business plans, securing £30,000 ($50,000 USD) in Cambridge development grants, including
    East of England (EEDA) funding. Organized business, recruited core management team, secured key
    contracts, led market analysis, and completed broad intellectual property submissions. Formed company
    as part of Business Plan Competition at the University of Cambridge, winning a cash prize and business
    support services.


MEDTRONIC EMERGENCY RESPONSE SYSTEMS         Redmond, WA
(Formerly Medtronic Physio-Control Corporation. Developer of LIFEPAK medical diagnostic and therapeutic
systems for cardiac emergencies: defibrillators, monitors, CPR devices, and data management systems.)

SENIOR PRINCIPAL SCIENTIST, BAKKEN FELLOW           2003 to 2005
    Directed transfer of several emerging technologies to product development, reporting to the business
    manager for advanced development. Member of both the Technology Review Committee and Clinical
    Studies Review Board, which formulated strategies and conducted milestone reviews for technology
    development and clinical research projects, respectively. Served as scientific lead for several clinical
    studies for submission to regulatory bodies in the US (Durham, Boston, Santa Cruz) and Europe
    (Copenhagen, Amsterdam).  
  • Managed four advanced technology development projects: two directed towards a new public
    access defibrillator product and two towards a new monitor product. Secured exclusive access to
    the components and patents, refined and qualified against requirements, and packaged for use in
    product, regulatory, and marketing materials.
  • Worked with marketing and with leading clinicians to define and ensure adherence to the claims and
    performance thresholds that must be met:
  • Defined a database suitable for benchmarking the performance and led a technical team, which
    evaluated candidate algorithms against database to optimize most promising candidate to meet the
    desired claims.
  • Collaborated with the business development and legal group to value and secure the exclusive
    access to the university’s technology and to the intellectual property behind the algorithm.
  • Participated in negotiation of the business / technology agreements and, in one case, acquired
    patents for $2 million against the $10 million asking price by the University of Pittsburgh.
  • Assembled cross-functional team, which defined and executed regulatory, marketing, testing, and
    clinical strategies.  Presented completed package to the Corporate Compliance review committee
    and received approval to transfer completed project to the development team, meeting the final
    milestone on schedule.
  • Reduced personnel costs by 50% in the research group through attrition and out-migration and
    redirected savings to support external alliances and clinical studies.

DIRECTOR OF RESEARCH                                        1999 to 2003
PROGRAM MANAGER, DIAGNOSTIC SYSTEMS        1997 to 1999
    Promoted to research group leadership, accountable for cultivating key relationships, identifying and
    developing emerging diagnostic and therapeutic solutions, and packaging them for use by product
    development teams. Administered $3 million annual budget, of which 70% was allocated to headcount,
    10% on capital, and 20% on external contracts. Increased department’s 20-member productivity while
    maintaining overall research contract spending at a constant $600,000 annually.
  • Achieved successful proof of concept on five of the six programs (optimal electrotherapy, shock-
    success prediction, reduced-lead MI detection, capnography, stroke, and hypothermia).
  • Oversaw development of methodology for continuous measurement of carbon dioxide concentration
    as a way of distinguishing patients suffering bronchospasm so that appropriate therapy could be
    administered. Defined a cooperative clinical- and intellectual property partnership with Oridion
    Medical (Tel Aviv, Israel), and developed contracts for collaborative development and marketing of
    the algorithm, which should increase market sales ten-fold.
  • Directed research investigations at leading academic electrotherapy lab, defining investigative
    programs, resourcing research projects, and driving presentation and publication of findings.


PHYSIO-CONTROL CORPORATION        Redmond, WA
(Medical Device and Diagnostic division of Eli Lilly, spun out to Bain Corp. in 1994, taken public in 1996, and
merged with Medtronic in 1999.)

PROJECT MANAGER, CODE-STAT DATA MANAGEMENT SYSTEM        1994 to 1997
    Following an international conference in Norway that recommended universal adoption of new reporting
    standards for cardiac arrest statistics, presented formal plan / proposal for Physio-Control to create the
    first data management system compliant to the standard. Accountable for product definition and execution
    of project through market release. Formed project team, recruiting and directing activities of technical,
    marketing, and manufacturing groups. Managed project budget, where time and staff were major cost
    drivers. Reported to research director and vice president of R&D.
  • Created product concept and led team that developed CODE-STAT, a software product that could
    document patient care, provide statistics describing treatment success, characterize EMS system
    utilization, and support continuous quality improvement research.  
  • First to market by over a year ahead of the nearest competitor, remaining superior in performance
    and capability.
  • Negotiated for the manufacture of finished product, securing low unit costs in return for a
    commitment to continue relationship as sales increase, but contingent on meeting quality goals.  
  • First to implement a software test program for a Windows-based product, and to define quality
    standards for medical informatics products. Implemented several new project technologies, including
    Access as product database, OLE for data exchanges, and cellular modem technologies for data
    communications.  

SR. RESEARCH SCIENTIST         1989 to 1993
RESEARCH SCIENTIST                1987 to 1989
    Involved in two major research and product development projects that addressed coronary issues.
    Collaborated with clinicians, researchers, paramedics, customers and representatives of medical systems,
    among others. Authored summaries and made numerous presentations to presentations to R&D,
    marketing, and management groups, and informal and formal scientific audiences.
  • Appointed to development team for the LIFEPAK 11, the first 12-lead ECG monitor coupled to a
    defibrillator, for paramedic use. Led clinical research efforts to devise data handling methods, set
    up project databases, analyzed the patient recordings, and developed an interpretive algorithm that
    could identify patients having blocked coronary arteries.
  • Created specialized version of AMI detection algorithm incorporating emerging Dutch standards.
    Moved from product definition to product release in six months, subsequently capturing 80% of
    Dutch market in this product category.
  • One of three scientists hired to create device that would non-invasively assess cardiac electrical
    activity so that an ECG marker of inducibility or non-inducibility could be located.


CADWELL LABORATORIES, INC.         Kennewick, WA
(Family-owned manufacturer of Neurodiagnostic instruments. Second largest in the field.)

DIRECTOR, CLINICAL RESEARCH, 1982 to 1987
    Recruited as application programmer and progressed to director of clinical research. Due to small, tightly
    held nature of organization, worked closely with all areas of the organizational structure, including
    marketing, sales, and service support. Played integral role in growth of company from $2 million to $10
    million through contributions on product research and development.


EDUCATION:
    University of Cambridge                    Cambridge, UK        
    MPhil (Distinction)            Bioscience Enterprise       2006
         Thesis: Creating global business opportunities from investment arbitrage in intellectual property

    Northwestern University                     Evanston, IL
    Doctor of Philosophy       Biomedical Engineering     1982
    Master of Science           Biomedical Engineering     1979
    Thesis:  Motor and neural components of binocular visual fusion.

    Vanderbilt University                          Nashville, TN
    Bachelor of Arts (Cum laude)                                   1976
    Physics and Applied Mathematics (Double major)

    Professional Development:
  • Stanford University    Certificate, Management Science  (2007)
  • The Medtronic Leader Program
  • ACLS Provider Skills Training
  • BLS CPR/AED certification: The American Heart Association


AFFILIATIONS:
Professional:
 Thesis Supervisor        University of Cambridge, Institute for Biotechnology
      Dan Bernad MD:
               Multi-dimensional analysis of strategies for bringing orphan medical devices to market.
      Ruben Quek:
               Risk-sharing opportunities to secure early reimbursement for medical device innovation.

Fellow                          American Institute for Medical and Biological Engineering
                                    Cambridge Philosophical Society

Senior Member             IEEE Engineering in Medicine and Biology Society

Board Member             International Society for Computerized Electrocardiology (2000 to 2006)

Editorial Board             Journal of Electrocardiography

Professional Member   American Heart Association
                                    European Resuscitation Council
                                    European Society of Cardiology
                                    National Association of EMS Physicians

Advisory Committee     University of Washington Medical Engineering Certificate Program (1999 to 2007)

Affiliated Investigator   Center for Information Technology Research in the Interest of Society,
                                       University of California

Member                       Puget Sound Stroke Interest Group
Curriculum Vitae