Medical device management

Former CTO medical device executive - created billion dollar products, started VC backed medical device companies, raised financing, took products through R&D, scale-up, FDA approval and launch. Patent Agent (USPTO registration number 60,144) and IP expert with 30+ patents

PROFESSIONAL EXPERIENCE

CliniSense Corp. Los Gatos, CA (Technology & IP consulting company)

Founder and principal, 2002-present

• Doing technology & IP consulting, emphasis on medical devices

• Acting CTO (consultant) for joint Beckman-Coulter & Panasonic diagnostics venture

• Working with leading law firms on IP (patent) writing, prosecution, infringement analysis, reexaminations, European oppositions, and litigation support.

• Invented new medical diagnostics, drug discovery, & robotics technology

• Developed new technology to detect deteriorated medical supplies, vaccines, & drugs

• Pro bono consulting support to Centers for Disease control (CDC) and World Health Organization (WHO) on vaccine supply-chain (cold-chain) stability issues

Avocet Medical, Inc., San Jose, CA

Founder and CTO/Chairman, Avocet Medical, Inc, San Jose, CA, 1991-2001

• Founded company, wrote business plan, raised $38 million VC & SBIR

• Took concept (AvoSure-PT home prothrombin time test) from "wild idea" to FDA approval

• Managed all technical activity including reagents & electronics instrumentation hardware & software from initial design to production

• Took charge of writing successful FDA 510(k) and response (regulatory expert ill)

• Coordinated work of all company VPs to ensure smooth launch, high quality.

• Produced AvoSure-PT home prothrombin time monitoring system

• Products had high manufacturing yields, and high customer satisfaction

• Sold to Beckman-Coulter in late 2001

Johnson & Johnson, LifeScan Inc., Mountain View, CA

Director of R&D and Operations 1985-1991

• Led operations department that scaled-up the One-TouchTM blood glucose system

• Built high performance operations team (members later behind Therasense)

• Led R&D department that did R&D behind successful SureStepTM blood glucose system

• Invented basic concept, made presentations, got upper management buy-in

• Extensive work with J&J corporate on advanced cardiovascular diagnostics

• Extensive work with J&J corporate on technology due diligence assessments

• Enabled extensive LifeScan revenue growth (1985 $35 M/yr to 2009 $1B+/yr)

EDUCATION

Baylor College of Medicine, Houston, TX

Assistant Professor of Pharmacology

• Research and teaching in biotechnology (cell biology).

• Used monoclonal antibodies as tools to study cell nuclear structure

• Published pioneering bioinformatics research (DNA sequence analysis software)

National Institutes of Health, NIAID Laboratory of Immunology, Bethesda, MD

Arthritis Foundation Postdoctoral Fellow

• Used monoclonal antibodies to study structure/function of immune system class II (Ia) antigen presenting cell surface receptors.

University of California, San Diego; Ph.D. Biology (Biophysics)

• Membrane biology - developed technology to analyze high molecular weight proteins.

• Extensive experience with immunochemistry & protein conjugation technology

University of California, Santa Barbara; College of Creative Studies

B.A. Physics, Biology, (Double major)

• Summer internships in molecular spectroscopy (physics) & early genetic engineering

• Continued affiliation with UCSB as a commencement speaker and instructor

31 patents (23 issued), 19 papers (available upon request)

SELECTED PATENTS

7,291,698 Synthetic substrates for high performance enzymatic assays (biotech)

7,288,368 Membrane receptor reagent and assay (drug discovery)

7,174,238 Mobile robot with web server and digital radio links (robotics & RFID)

7,166,208 Apoenzyme reactivation electrochemical detection method and assay (diagnostics)

7,102,526 Electronic time-temperature indicator and logger (supply chain – stability sensors)

7,096,090 Mobile robotic router with web server and digital radio links (robotics & data routers)

6,984,307 Dual Glucose-Hydroxybutyrate Analytical Sensors (diabetes diagnostics)

6,575,900 Meter with integrated database and simplified telemedicine capability (telemedicine)

5,968,836 Fluid conducting test strip with transport medium (basis for LifeScan SureStep™)

5,580,744 Test article and method for performing blood coagulation assays (medical diagnostics)

5,418,141 Test articles for performing dry reagent prothrombin time assays (medical diagnostics)

SELECTED PUBLICATIONS

Zweig SE: “Advances in vaccine stability monitoring technology”, Vaccine, 2006 Aug 14;24(33-34):5977-85 (New technology to safeguard against deteriorated vaccines)

Zweig SE: “21st century electronics for 21st century drugs”, Drug Delivery Reports, Spring/Summer 2006 (New technology to safeguard against deteriorated drugs)

Zweig SE, Meyer BG, Sharma S, Min C, Krakower JM, Shohet SB: Membrane-based, dry-reagent prothrombin time tests. Biomed Instrum Technol. 30(3): 245-56 (1996). (Awarded “best research paper of 1996” by the American Association of Medical Instrumentation)

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