medical device

Medical Device: Development

During Development, the physical product is ultimately created and tested. Key activities include 1) developing the product, 2) testing it, 3) operations preparation, 4) monitoring the market, and 5) project risk.

Some companies start their product development process at Development, ignoring important Discovery activities. This practice leads to a product that might not solve the customer’s problem, with compounded issues of creating a product that is not commercially or technically feasible. Skipping Discovery does not speed up time to market; actually, it has an adverse effect.

Developing the Product

The outputs from Discovery are an understanding of customer needs, system-level design inputs, and technical feasibility. At Development, system-level product requirements (design inputs) are further refined and decomposed into lower-level requirements as needed, prototypes are built and tested, and the design is selected.  Design reviews are used to evaluate the product during development.

User feedback should be incorporated into the design process. Using prototypes, the design team should obtain feedback from potential users on usability and human factors.

During product design, an important part of product development is supplier selection and qualification, along with ensuring that the supplier’s component meets requirements. The company should work with the members of its supply chain or purchasing organization and with the quality-assurance group to select the right suppliers. Where appropriate, it also is helpful to work with suppliers, to leverage their expertise in delivering materials that reliably meet the design and purchasing requirements.

As part of design for manufacturability (DFM), it is important to work closely with operations to ensure that designs can be easily manufactured. Teams should integrate learnings from the following experiences:

  • Manufacturing similar products
  • Changes to a product by operations after launch to improve manufacturability

It is important to visit the manufacturing location and work with production to walk through the design, test requirements, potential fixtures, etc.

Expectations from the regulatory bodies continue to evolve during Development. It is crucial to work with the regulatory, quality, and standards groups to ensure the product will meet the requirements at launch.

At some point during Development, the design should be frozen. After this design freeze, product changes need to be managed and evaluated for impact against design inputs, suitability of data generated on a previous design, and product risk.

Testing the Product

Development must be demonstrate that the product meets the design inputs (Did you design what you planned?) and customer requirements (Is the design what the customer wanted?). This occurs through design verification and design validation (V&V).

While verification and validation are design control terms, they are also good engineering practices. Product developers need to ensure that the product will perform as intended and is reliable (verification), and that it will solve the customer problem that initiated the project (validation).

Operations Preparation

Ultimately, manufacturing needs to demonstrate that it can reliably deliver the designed product. It may be obvious, but operations should be included in the design for manufacturability discussions. Process V&V is focused on the ability to make the same product repeatedly. Using the product documents and drawing, operations manufactures the product. Often equipment qualifications plus pre-production/first article inspections are used to demonstrate that the product has been successfully transferred from design to operations.

Monitoring the Market

During Development, most of the attention is focused on design, testing, and operations preparation. However, it is just as important to ensure that the market opportunity is still applicable. Especially for products with long development times, the project team may find that the customer need has been addressed in another way, the competitive or intellectual property landscaped has changed, or the early assessment of the market no longer applies.

During Development, the product manager, working with sales, also generates the launch forecast. The forecast needs to reflect launch timing, by country, and include sample and initial stock volumes. This information will be provided to operations for launch preparation and inventory creation.

Project Risk

During the project, the team continues to drive down uncertainty. Project risk continues to be identified, monitored, updated regularly, and managed as part of the product development process.

Outputs to Commercialization

Key outputs are the designed product, completed product (design) and process verification and validation, and continued assessment of market viability.

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Mary Drotar, Partner
Strategy 2 Market, Inc.
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