5.2 R&D Strategy

Chapter 5.2
Additional Resources

R&D activities must remain closely linked to prototyping and clinical efforts and should not be developed in isolation.  The steps below have been excerpted from Chapter 5.2 and are presented with active web links to assist innovators in getting started in developing a well-integrated, effective R&D strategy.

Determine Strategic R&D Milestones
  1. What to Cover – Identify critical R&D milestones necessary to achieve the company’s R&D goals, as well as its broader goals for the development of a commercial-ready product. These milestones should correspond to outcomes that allow the company to retire important risks. Such milestones might include proof-of-concept, first prototype that performs effectively in a bench model, first prototype that performs effectively in tissue testing, first prototype that performs safely and effectively in live animals, first prototype that performs safely and effectively in humans, preproduction device that demonstrates manufacturing feasibility, and/or production device that supports scalable manufacturing. Consider different sets of critical milestones, alternative ways of sequencing them, and the strategic implications of changing the sequence and order of the milestones.
  2. Where to Look – Refer to 6.1 Operating Plan & Financial Model for more information about setting milestones. Network with other experienced innovators and professional advisors for assistance in defining milestones and estimating a reasonable time frame for achieving them.

Identify and Prioritize Key Technical Challenges
  1. What to Cover – Define the significant technical, clinical, and manufacturing design challenges that must be solved to achieve each milestone. Once identified, these technical challenges should be prioritized based on the level of uncertainty and risk they present to the project. Seek to resolve those challenges with the greatest risk as early in the engineering process as possible, working within whatever constraints may exist within the company.
  2. Where to Look 

Develop an Initial R&D Plan
  1. What to Cover – Build a “shell” of the quality system that supports the company’s R&D strategy. Map out the high-level requirements and processes of the quality system from “end to end” (i.e., from design through manufacturing, distribution, and post-marketing surveillance). Then, depending on the stage of the company and its product(s), determine which processes and procedures need to be developed further at any particular point in time. Design control is usually one of the first elements to be developed at the tactical level. Change/document control often comes next, followed by corrective/preventive action processes (to guide continuous improvement), and then production/process controls. These elements should be built out (following the guidelines provided in the quality policy and working within the construct of the quality system “shell”) as they are needed, based on the company’s R&D progress.
  2. Where to Look – Books on R&D may be helpful in considering requirements related to engineering personnel and resources:
    • Steven C. Wheelwright and Kim B. Clark, Managing New Product and Process Development (Free Press) 1992 – See chapter 6, 8, and 9.
    • Karl Ulrich and Steven E. Eppinger, Product Design and Development (McGraw-Hill/Irwin) 2003 – See chapter 14 and resources available at http://www.ulrich-eppinger.net/.
    • Theodore R. Kucklick, The Medical Device Handbook (Taylor & Francis Group: Boca Raton) 2006.
    • Paul H. King and Richard C. Fries, Design of Biomedical Devices and Systems (Marcel Dekker, Inc.: New York) 2003.
    • Gerard Voland, Engineering by Design (Pearson Prentice Hall: Upper Saddle River) 2004.

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