TERRY N. LAYTON, Ph.D.
`1771 RFD Andrew Court
`Long Grove, IL 60047
`847.254.9295 (Cell)
`Primary (tlayton71@aol.com) Secondary ( tnl@uic.edu)
`Career Summary
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`Technical executive with strong background in building medical manufacturing companies.
`Diverse experience includes industry and consulting experience in product development,
`regulatory/QA, operations, IP, failure investigation and technology assessment.
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`Instructor and lecturer for Bioentrepreneur classes and seminars on medical device design
`and regulations, product development, emerging medical technologies, medical device
`commercialization and medical device industry skill sets.
`Qualification Summary
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`Experienced innovative leader and manager proficient in product design, regulatory
`approval, and clinical evaluation for new health care markets and business ventures.
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` Managed engineers, scientists, regulatory professionals & plant personnel
` Due diligence on 10 companies – 6 purchased; Licensed 4 technologies
` Developed and taught 4 Bioentrepreneur classes at University of Illinois, Chicago
` National Institutes of Health (NIH) consultant for Small Business Innovation
`Research Grants 1992-present
` FDA Medical Devices Advisory Committee - industry representative 2001-2005,
`2008-2013.
` Network of Centres of Excellence-Canada; Regenerative Medicine Network & Stem
`Cell Network 2003-2005; BioMedlight 2011; Institute of Circulatory and
`Respiratory Health (ICRH) Emerging Networks 2012-13
` Kentucky Science & Technology Corporation - Expert Panel 2007, 2009-2014
` Defense Medical Research and Development Program 2009-2010
` Design of Medical Devices Conference 2011-Urology Products; CoChair
`18 US Medical Device Patents issued and over 45 new products released to market
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` Regulatory submissions-US and International; Fifteen (15) 510(k)s & CE Mark for
`138 product codes
` Short term consulting assignments on, technology assessment, QSR, QM, regulatory
`documentation, product failure investigation, failure mode analysis, and audits.
`35 Publications and presentations on medical devices and medical device skill sets
`for engineers in industry
` Provide technical assistance and guidance to medical device start-up companies
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`Tlayton71@aol.com
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`tnl@uic.edu
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`ANCESTRY EX. 1004
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`TERRY N. LAYTON, Ph.D.
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`Medical Device Experiences
`(product development, regulatory and/or commercialization)
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`Anesthesiology
`Catheters
`Implants
`Home Health Care
`Orthopaedic
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`Transducers
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` Assistive Technology
` Critical Care
` Instruments
` Monitoring Electrodes
` Rehabilitation
` Urology
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` Cardiovascular
` Endoscopy
`IV Systems
`Neurosurgery
` Respiratory Therapy
`Vascular Compression
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`Experience
`University of Illinois, Chicago
`
` Nov 2000—Present
`
`- Visiting Professor Bioengineering—University of Illinois, Chicago
`- Lecturer: Technology Assessment & Medical Device Start-Up Companies, Emerging
`Medical Technologies, Medical Product Development, & GMP and Regulatory
`Requirements for Medical Products
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`Laytech Inc
`Long Grove, IL
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` Nov 1999—Present
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`Consulting & Contract Services
`- Technology Assessment Of Products and Processes
`- Regulatory & Quality—QSR, QM, submissions, audits, failure modes, & documentation
`- Start-up and Business Plans and Intellectual Property for new medical device companies
`- Legal-IP (Infringement & Invalidity), Failure Mode Investigations & Expert Reports
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`Integra NeuroCare/NeuroCare Group
`Pleasant Prairie, Wisconsin
`(Worldwide leader in neurosurgical implants and monitoring devices)
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` July 1994 – October 1999
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`Vice President, Group Technical Officer
`- On the original due diligence team for the purchase of the fist platform company (Heyer-
`Schulte, a neurosurgical implant company) for the NeuroCare Group.
`- Built technical organization, established US customer service & distribution departments &
`technically managed Puerto Rican manufacturing facility.
`- Member of due diligence team for the purchase of 3 additional companies.
`- Searched for, assessed, and licensed 2 major technologies used in present products.
`- Obtained 11 510(k)s
`-
`ISO Certification of 2 facilities and CE Mark for 138 product codes.
`- Developed and released to market 20 new products in 5 years.
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`Tlayton71@aol.com
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`tnl@uic.edu
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`1.847.254.9295
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`TERRY N. LAYTON, Ph.D.
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`Experience
`Packer Engineering, Inc. December 1991-July 1994
`Naperville, Illinois
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`Director, Biomedical Engineering
`- Start-up of a new Biomedical Division
`- Technology transfer of an electro-mechanical rehabilitation device with a market potential of
`$5 million in 3 years.
`- Technology assessment of new concepts for both small and large medical device companies.
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`In first year received grants and contracts for over $500,000.
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`- Failure Investigations
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`Laytech, Incorporated
`Arlington Heights, Illinois
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` March 1990 – December 1991
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`Technical Officer
`- Coordinate manufacturing of disposable medical products
`- Consulting assignments on technology assessment, product and process improvements,
`materials, and quality issues
`- Product development, project management, failure mode analysis and FDA submissions
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`Baxter Healthcare Corporation May 1988 – March 1990
`Round Lake, Illinois
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`Manager, Advanced Device Technology
`- Managed the engineering and product service activities for Vein Access product line.
`- Managed the final design and implementation phases of a new technology that prevents
`accidental needle sticks---needle less access.
`- Searched for and assessed new technologies that added value to products and processes.
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`The Kendall Company June 1975 – May 1988
`Barrington, Illinois
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`Manager, Medical & Sports Medicine Divisions
`Section Head, Medical Specialties
`Senior Research Scientist/Engineer
`Research Scientist/Engineer
`- Presented new product concepts and business opportunities to upper management.
`Products brought incremental sales volume of over $5 million to the sales base of
`$35 million.
`- Urodynamic products-designed, clinically tested, and published results
`- Technical responsibility of latex catheter plant in Malaysia.
`- Managed Colgate/Bike Plastics Product Development
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`Tlayton71@aol.com
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`tnl@uic.edu
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`1.847.254.9295
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`TERRY N. LAYTON, Ph.D.
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`Professional Societies (past and present)
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`ISPE-International Society of Pharmaceutical Engineers
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`Society of Plastic Engineers
`BMES – Biomedical Engineering Society
`IEEE - Institute of Electrical Electronics Engineers
`IV Nurses Society
`Urodynamics Society
`Medical Device Guidance and Standards Committees
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`Education
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`Ph.D., Biomedical Engineering, University of Virginia, Charlottesville, VA
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`M.S., Bioengineering, University of Illinois @ Chicago
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`Electrical Engineering, University of Illinois, Champaign, IL
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`B.S., University of Wyoming, Laramie, WY
`High School, Moline Senior High, Moline, IL
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`Continuing Education
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`FDA/ASQ Quality System Inspection Technique
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`ISO 9000 Auditor Training
`Medical Device Pre-Marketing/GMP Requirements Workshop
`OSHA Guidelines
`FDA Design Control
`Liability Prevention for the New Millennium
`Project Management
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`Research Disclosures
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`Ten publications
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`Twenty-four presentations
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`Patents
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`Eighteen issued
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`Military Service
`U.S. Army
`Honor Graduate, Officer Candidate School
`Instructor, Artillery School
`Battalion Staff, South Korea
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`TNL 2015
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`Tlayton71@aol.com
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`tnl@uic.edu
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`1.847.254.9295
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