Considerations for Optimizing the Medical Device Development Process—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Starting a new project can be an exciting time for medical device developers as they are eager to test a new idea or concept and potentially address a serious clinical condition. Unfortunately, moving too quickly without the right partners in place can create challenges later in the product lifecycle. These issues can delay a project, add expenses, or significantly derail the venture.

As such, it’s important to ensure the ideal supply chain partners are aligned early in a new project. Getting their input on a variety of factors, such as material selection, prototyping, design for manufacturability, testing, and regulatory, early can help ensure a smoother pathway to market. Considering multiple aspects of the full production before design freeze helps to optimize the undertaking.

To help further explain why it’s so important to have a key development and manufacturing partner at the table for early design work, John Freedman, VP of Sales and Marketing at Innovize, responded to several questions on the topic. In the following Q&A, he expands on the factors mentioned while also outlining the benefits of working with a company like his.

Sean Fenske: When starting a new medical device project, when should a partner like Innovize be brought in? Why?

John Freedman: As early as possible, ideally in the early design stage before design freeze. Early involvement allows design for manufacturability, cost, and regulatory considerations to shape the design rather than force costly redesign later. Waiting until after design freeze often means retrofitting a design to manufacturing constraints instead of building manufacturability in from the start.

Fenske: How does a development partner help with material selection? What factors are important before making a final decision?

Freedman: A development partner brings knowledge of how materials behave in actual manufacturing processes rather than just on paper. Material selection is more than just how strong an adhesive is or how low a release force the material provides. One needs to consider how the material performs in the production process, which is something the development partner brings to the table. Additional key factors include biocompatibility, sterilization compatibility, supply chain stability, cost, and regulatory/traceability requirements. The right partner weighs these against long-term production scalability, not just prototype performance.

Fenske: How long is the prototyping phase? Do companies expect to “get it right” with V1? What can be revealed during this stage?

Freedman: Prototyping timelines vary widely by device complexity, but it is rarely a single pass. Companies generally do not expect to get it right with version one; iteration is the norm. This stage often reveals manufacturability issues, tolerance stack-up problems, and material or process incompatibilities that weren’t apparent on paper.

Fenske: How does the right development partner aid with Design for Manufacturability (DFM) and Design for Testing (DFT)? Why is this important?

Freedman: An experienced partner reviews designs against actual production and test capabilities early, flagging features that are difficult to assemble or inspect at scale. This matters because a design that works in a lab can be difficult or expensive to produce consistently at volume. Addressing DFM/DFT early reduces the potential for change, cost, scrap, and quality risks downstream.

Fenske: What level and type of regulatory support should a development partner provide? What benefits are realized here?

Freedman: A development partner should understand and operate within frameworks like ISO 13485 and FDA 21 CFR Part 820, supporting design controls, documentation, and traceability throughout development. This shared accountability reduces the burden on the OEM’s regulatory team and lowers the risk of compliance gaps at submission or audit.

Fenske: What are the benefits of working with a development partner that also provides contract manufacturing services?

Freedman: Combining development and manufacturing under one partner reduces handoff risk, since the team designing the device also understands how it will be built at scale. It can shorten the time to market by avoiding a second learning curve when transferring to a new manufacturing partner. It also creates a single point of accountability for quality and continuity across the product lifecycle.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Freedman: What I’d add is that our partnerships are not transactional. You’re assigned a dedicated team: sales, project managers, schedulers, engineers, with each person’s role communicated up front so there’s no ambiguity about who owns what. We stay engaged from feasibility through launch and beyond. None of that works without clear requirements, defined timelines, stable specs, and timely feedback from the customer’s side. This is a two-way partnership: we move fast, but never at the expense of compliance or quality, and that only holds if both sides communicate consistently as things change.

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