In a previous blog, we covered the Discovery portion of medical device product development, where the outputs are an understanding of customer needs, system-level design inputs, and technical feasibility, along with a clear market understanding. In this blog, I’ll address Development.
During Development, the physical product is created and tested. In addition, the activities to deliver the product to the market are completed. Key activities include:
- Developing the product
- Testing it
- Operations preparation
- Monitoring the market
- 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 compounding issues of creating a product that is not commercially or technically feasible. You should only move to development, once the key activities of Discovery have been completed
1. Developing the Product
During 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.
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 the suppliers, to leverage their expertise in delivering materials that reliably meet the design and purchasing requirements. For example, a molding company may have useful input on mold design or materials which leads to more reliable parts.
As part of design for manufacturability (DFM), it is important to work closely with operations to ensure that designs can be reliably 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, generally just before formal testing, the design should be frozen. After this design freeze, product changes need to be tracked and evaluated for impact against design inputs, suitability of data generated on a previous design, retest requirements, and product risk.
2. 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, and that it will solve the customer problem that initiated the project.
When testing the product, especially if the data will be used as evidence in the design history file, document the following.
- A protocol with established acceptance criteria, prior to testing
- Complete pedigree of all the materials used in the test. This includes
- All components: subassemblies may be used, but you need to know exactly what went into it and how it was made
- Validated test methods
- Calibrated equipment
- Location of testing
- Raw data
- Summary report with conclusions and approvals
You will also need to document any changes to the product after testing, along with explanations of why the data is still acceptable or any additional supporting data (change management).
3. 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 while you are developing the product.
Process V&V is focused on the ability to make the same product repeatedly. Using the product documents and drawings, 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. (Click here for additional information.)
4. 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 viable. 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.
5. 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.
The key outputs from Development are the designed product, completed design and process verification and validation, and continued assessment of market viability. Our next post in this 3 part series will be on Commercialization.