Overview:
Experienced global leader in medical device innovation and new business development, creating profitable new
products for diagnostic and informatics markets. Able to unlock value in emerging technologies; experienced at
evaluating market potential and technical feasibility, developing clinical evidence portfolios, and managing cross-
functional teams. Demonstrated ability to make strategic choices, anticipate and mitigate risks, analyze financial
and operating data, and develop and retain individuals who can make critical contributions to organizational
success. Background includes a doctorate from Northwestern University and a business degree from the
University of Cambridge (UK).
US citizen with extensive expatriate experience, both Dutch and UK work permits
and residences
; at ease working with diverse teams and customers in international settings to create innovative
high-growth businesses spanning diagnostics, informatics, and therapy delivery.

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:

STONE BRIDGE BIOMEDICAL BV         Maastricht, NL
(Startup – Remote medical monitoring systems for cardiac resuscitative emergencies.)

FOUNDER AND PRINCIPAL
2009 to present
Dutch corporation developing software and sensors for remote monitoring of patients at significant risk of life-
threatening cardiac events. Authored business and development plans, defining the target markets and
regulatory strategy for bringing investigative systems through Phase I trials.  Currently establishing global
partnerships for co-development and licensing of enabling technology and recruiting clinical centers for
feasibility studies.


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

DIRECTOR, SQDM SENIOR STAFF /  CORE BUSINESS LEAD, ACUTE CARE DIAGNOSTICS
Nov. 2006 to May, 2009
Expatriate assignment to the Netherlands, reporting to the general manager, with three distinct areas of
accountability: Staff management of business unit strategy and operations; business director for acute-care
device and market development; functional director for Research and Technology. Led a cross-functional Dutch
team with outside physicians and technology partners to develop profitable growth opportunities in emerging
monitoring and alerting businesses.  

Key Contributions:
  • Global sales grew by 70% in FY ’07 with 80% gross margins, bringing the company to profitability in its
    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)

Founder and
CEO
2006 to Present
    Co-founded medical therapeutics company based on proprietary biofilm-resistant polymer. Wrote and
    presented business plans, securing £220,000 ($400,000)  in Cambridge development grants, including
    East of England (EEDA) funding and angel investment. 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 concept development, market evolution, and technical transfer of 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 clinical studies in the US (Durham, Boston, Santa Cruz) and Europe
    (Copenhagen, Amsterdam), which led to successful regulatory submissions.  
  • 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 Business School -- Management Sciences Certificate (2009)
  • The Medtronic Leader Program
  • ACLS Provider Skills Training
  • BLS CPR/AED certification: The American Heart Association


AFFILIATIONS:
Professional:
Senior Associate        University of Cambridge, Institute for Biotechnology
                               - Course Coordinator/Lecturer: Medical Diagnostics and Devices
                               - Thesis Supervisor
    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