About JD Consulting
JD Consulting was co-founded in 1992 by Jack Dhuwalia and Jayne Shinoda.
We have had the privilege of working with many top-tier Medical Manufacturers, including those below:
- Alpha Therapeutic Corporation
- Medtronic Cardiopulmunary
- Sorin Biomedical
- Gensci OrthoBio. (Integra)
- SynCardia, Inc.
- General Electric-Amersham, Labs
- Mallinckrodt Medical
- QLT Photo therapeutics
- SSL Intl. (Reckitt Benckiser)
- Edwards Lifesciences Inc.
JD Consulting Major Accomplishments:
Manufacturing Problem Solving
- Process/product improvement of blood oxygenator and related products. Reduced manufacturing rejects by over 10%. Saved company over $250K/yr. by reducing waste, streamlining operations, improving reliability/redesign
- Solved a significant quality/regulatory problem for brachytherapy – saving over $400K/yr.
Quality/Regulatory Medical Manufacturing Solutions
- Prepared a Class II device company in India for FDA QSIT inspection
- Reduced regulatory risk by 83% of a multinational client for brachytherapy
- Solved a quality/regulatory problem by implementing a new sterile packaging system at a multinational client under FDA warning letter situation
- Implemented technical solutions to prevent a potential product recall for a start-up
- Implemented design control programs and performed FMEA hazard analysis
- Process validations for extrusion, injection molding, manufacturing & packaging equipment and sterilization
- Conducted rapid corrective actions to bring molding operations into regulatory compliance
- Implemented a custom QSR / ISO 13485 compliant design control program
- Established quality systems. Prepared quality manuals and procedures
- Design control administration and implementation for a multinational project
- Updated GMP programs to current QSR requirements to improve compliance
- Prepared 510(k) submissions
- Responded to and corrected 483 problems
- Resolved problems with sterilization and completed sterilization validations
- Conducted ISO 13485,QSR, MDD and cGMP second and third party audits for compliance
- Implemented process, package, sterilization (EtO, Gamma and e-Beam Irradiation) validations
Medical Manufacturing Product Development
- Manufacturing technology transfer of an embolectomy catheter to Singapore
- Developed an introducer system for laser fibers in transurethral treatment.
- Design, development and 510(k) for a phonation valve
- Worked with client and subcontractors in development through regulatory approval of laser fiber optic device for photo-dynamic therapy for treatment of esophageal cancer