JD Consulting Principal Medical Industry Consultant

Jayne Shinoda, RAC

Jayne ShinodaJayne brings more than 25 years of broad medical device, pharmaceutical and diagnostic product experience in process validation, product development, materials, laboratory design and quality systems.

She has extensive experience in the areas of laboratory management, Quality Assurance, Sterilization and Regulatory/Clinical Affairs. She has strong mechanical and communication skills with a track record of successful solutions.

Jayne has been involved with hemodialysis devices, heart lung bypass circuits, IV infusion pumps, lasers and fiber optic laser catheters. She has recently been assisting clients with GMP and ISO 13485 compliance, audits, design controls, sterilization and validation programs, and possesses extensive experience in regulatory and safety certification programs, and regulatory submissions. She studied Biochemistry at the University of California at Berkeley.

Jayne Shinoda Extensive Experience and Qualifications:

Ms. Shinoda brings more than 25 years of broad medical device, pharmaceutical and diagnostic product experience in process validation, product development, materials, laboratory design and quality systems. She has extensive experience in the areas of laboratory management, Quality Assurance, Sterilization and Regulatory/Clinical Affairs. She has strong mechanical and communication skills with a track record of successful solutions.

The ideal client for Jayne understands the necessity of well designed and workable solutions to the success of an organization.

Experience:

As a partner and Systems Specialist since 1992 for JD Consulting providing clients with domestic and international client support in USP-NF, ISO, cGMP, QSR compliance; process validation, audit, technical file/dossier development, regulatory submissions, and sterilization validation.

Working with a broad range of clients and their unique systems and organization, Ms. Shinoda quickly assesses the necessary course of action to efficiently accomplish the client's immediate and long-term goals.

Client Companies - Start-ups/Large Corporate Divisions Include:

  • Endevco Corp.
  • World Minerals
  • Alpha Therapeutic Corp.
  • Amersham Health
  • QLT PhotoTherapeutics
  • MPS Acacia
  • GenSci OrthoBiologics Inc.,
  • Alliance Medical Technologies
  • Mallinckrodt Medical
  • Sorin Biomedical
  • Amgen

Detailed Accomplishments:

  • Drug eluting stent development: Designed, built and managed a pilot plant product test laboratory for a QSR based DES combination product during method development and validation for pre-clinical and OUS clinical trials. Responsibility included technical dossier support for materials, pre-clinical testing, and ISO 10993 biocompatibility testing strategies.
  • Drug eluting stent sterilization validation: Rescued a sterilization validation report for intermittent and small lot within two weeks of project assignment after five months of delays jeopardizing a CE mark application.
  • Ocular pressure sensing device housing: Successful material selection and design of a responsive patient contact membrane for a new ophthalmic application for a piezoresistive silicon pressure transducer.
  • Biologic product excipient material qualification: Qualification of an alternate supplier for heparin excipient used in a marketed human plasma fraction biologic product resulting in a $2M annual savings and payback in approximately six months.
  • Brachytherapy device custom design control program: Developed and implemented a comprehensive custom QSR / ISO 13485 compliant design control program which corrected a threatened injunction action by the FDA.  This program was later adapted for other EU locations within the UK based company.
  • QSR and cGMP quality systems application: Formerly certified Lead Auditor to conducted ISO/QSR second and third party audits, and supplier audits.
  • Laser angioplasty clinical trial monitor: Management of IDE clinical trials of laser angioplasty systems used in peripheral vascular recanalization and provided the clinical interface for the development of an orthopedic laser holmium laser system.

Cardiovascular Electronics-Monitoring Equipment Compliance:

  • Organization of a new regulatory affairs operating group in a newly formed electronics manufacturing division. Managed regulatory and UL/CSA safety certification activities for four product lines; disposable and reusable pressure transducers, autopheresis machines, IV infusion pumps, and critical care thermal dilution monitors.
  • Diagnostic products: Established product field quality reporting program and FDA inspection protocol. Duties included conducting clinical diagnostic reagent standardization studies, upgrading long-term and accelerated stability program, and serving as primary contact for California and federal FDA inspections.
  • Applied hollow fiber (dialyzer membrane oxygenators) laboratory:
    • Responsible for test and clinical evaluation of sterile disposable devices and hollow fiber dialyzers, hemoconcentrators, and membrane oxygenators.
    • Transferred lab operations from California to Florida and designed the new Florida lab operation.

Education and certification:

Jayne may be contacted by calling 949-701-0004 or by This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

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