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Before Design: Thoroughly Evaluate Your Concept

Medical Device & Diagnostic Industry Magazine | MDDI Article Index

DESIGNER'S TOOLBOX

A close look at all angles of a design from concept to completion can enable the design team to meet development goals on time and on budget.

A lot of effort is required to take a medical device from the concept stage through to distribution and sales. This article addresses effective ways to evaluate the viability of a basic concept before expending major company resources. Concept evaluation, refinement, and reevaluation should begin immediately after an idea is conceived and should be an ongoing process throughout the development and market life of the product.

Before beginning an in-depth evaluation, the development team should be in place. A project champion should be assigned to coordinate collection of information from the affected company functions to create a preliminary plan and report. Such a report provides management with sufficient basis to authorize and fund the project. Figure 1 is a checklist for organizing a product development plan. A chart enables the development team to anticipate and track the interaction between the activities and events. The plan should become a living document that creates as a minimum the following criteria.

Product Description. Describe the medical function the product is intended to perform and the benefit it will provide the marketplace. Discuss the potential technological and manufacturing advantages and weaknesses.

Medical Efficacy. Provide qualified medical opinions of the proposed device. This is an ongoing function from initial concept review through to completion of clinical trials, if required, and the evaluation thereof. The medical investigators should be involved from the earliest discussions of the concept.

Patent Protection and Infringement Potential. Include legal opinions. The patent is a critical aspect of any design project, and legal issues should be considered almost simultaneously with the consideration of the concept. It is important to regularly monitor possible infringement. Systematic review of patents for similar devices issued during the life of the project is essential.

Probable Regulatory Requirements. Predict likely regulatory status, such as 510(k), investigational device exemption (IDE), or premarket approval application (PMA). If a predicate device exists upon which to base a 510(k) submission, then proceed toward making the case in the early stages of planning. Determining this information early provides the design team with a critical factor in development: the time it will take to prepare appropriate documentation as well as an indication of how long FDA will need to process it.

Market Potential. Speculate market sensitivity to function, price, and features early. Refine this information on a regular basis as data are collected from surveys, focus groups, discussions with potential users, and buying groups. This provides the development team with information needed to make appropriate decisions regarding configuration, features, and fabrication methods.

Development and Manufacturing Costs. Estimate possible modes of fabrication and probable make or buy decisions. Cover basic manufacturing questions, proposed automation, and tooling. Use cost and sales estimates to provide potential break-even point analysis and the product's likely contribution to margins.

Probable Staff and Support Needs. Provide an estimate of personnel and outside services needed to support the project so that management can plan for appropriate staffing levels and can factor these costs into its funding decision.

If the project is approved and funded, continual review and refinement of the concept becomes a key charter for the development team along with regular reporting of status. The purpose of reviews should be the approval of ongoing activities and budgets based on demonstrable results. The timing of reviews should be based on reaching key events and milestones in the project.

PRODUCT DEVELOPMENT PLAN CHECKLIST

  • Clinical trials plan
  • Design reviews
  • Development schedule
  • Employee training
  • Facilities and maintenance
  • Financial analysis
  • Failure modes and effects analysis (FMEA)
  • Focus group organization
  • Manufacturing plan
  • Market analyses
  • Materials selection
  • Medical efficacy reviews
  • Models and prototypes
  • Packaging and labeling
  • Patent reviews
  • Process validation
  • Product description
  • Quality assurance plan
  • Regulatory requirements
  • Staff and consulting needs
  • Sterilization plan
  • Vendor selection

    (Tasks listed alphabetically)

    Floyd V. Edwards is a consultant to the device industry and a member of MD&DI's editorial advisory board.

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