Dear Medical Device Professional:
Perhaps you have considered using outside consulting to augment your in-house staff. If so, I hope the following will help you decide if my services are right for you or not. If you don’t believe that your company could benefit from consulting, I hope you’ll read on, I may convince you otherwise.
Device Design assists clients through the complete process of Product Realization, with 30 years experience in start-up Medical Device companies in varied roles. This experience has been gained throughout many Product Life Cycles. This is combined with “hands on” skills and knowledge, not just theory.
The advantages of using Device Design are:
R&D Support. Skilled R&D staffs are a valuable commodity. Using their time and effort on Design for Manufacturability, Manufacturing Transfers and Operations issues dilutes their contributions in bringing new products to market. What is the cost of lengthening a product introduction cycle?
Design and Manufacturing Transfers (DMT). While the knowledge needed to develop and design a device or disposable is as varied as there are Diagnostic and Therapeutic technologies, DMT revolves around a very different and well-defined skill set. Why have R&D resources spend precious time learning these lessons?
Qualification Test Plans and Reports. Most of the clients I serve are in early-phase development and, as such will need to develop Test Plans to support V&V activities, Packaging Performance, Biocompatibility, Shelf Life and/or Sterile barrier testing. I have experience in authoring all these protocols for a variety of companies over the last 30 years.
Risk analysis d,pFMEAs Third Edition requirements now mandate concurrent Risk Evaluation during the Design Process. I can assist your in-house team to produce the required “bottom up” risk analysis from Design Input Specifications and Manufacturing Work Instructions.
Please let me know how I can address your company’s challenges.
Richard Hatch
Company’s Keywords:
capital equipment & disposables, machining & forming, product transfers, rampd, prototyping, verification & validation, dfm, product development, cryogen & delivery systems, rf surgical systems, materials & adhesives, rd
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