Business leaders in the medical device industry often consider bringing in external regulatory expertise to lead or participate in projects to develop regulatory submissions and bring devices to market. This article utilizes the metaphor of building a house to outline some best practices for cost-effective ways to utilize external expertise to build a successful submission.

To begin the metaphor, the reader is invited to identify the need for a house. We will assume the intent of building this hypothetical house is to place it on the market, as opposed to building it as a residence for the builder. We will call the entity planning to build the house the “owner.”

The owner starts with a broad idea of what is wanted, and refines that with a list of features. This is similar to design input for a medical device. The owner also sets a broad cost ceiling and a target date for when the house will be ready for the market.

The owner also determines if she has the resources to build the house or if she wants to bring in external support such as an architect, a design-build firm, or a general contractor. We will assume, for this comparison, the owner has the resources to act as a general contractor, and she decides she needs help with a design and a plan for putting all of the pieces of the project together. The owner decides to hire an architect. And, for this analogy, we will consider the architect to be comparable to a regulatory consultant.

The process is similar to develop and bring to market a medical device. The manufacturer, or owner, will go through the design control process, establish a budget, and set a target date for the market. We will refer to the manufacturer or owner as the “sponsor.”

Similarly, the medical device sponsor will want to do a critical assessment of resources and may decide to bring in an external resource(s) with experience in navigating the regulatory pathway. The following questions are pertinent: Does the sponsor have considerable in-house expertise (e.g., regulatory, QA, R&D, etc.) that she is willing to commit to work on this project? Or does she expect the consultant to arrange testing, compile test reports, prepare documents, etc.? If the latter, then the sponsor needs the regulatory consultant to be more like a design-build firm.

If, however, the sponsor can commit many of her own resources, she would contract with a regulatory consultant to act the same as an architect in a construction project. The consultant would meet with the development team to learn about the device, the intended use, competitors (and/or predicates¹), the validation and verification plan, and claims. The consultant would then prepare a rough regulatory plan and would vet that with the team. The plan might go through several iterations, especially in consultation with R&D, or engineering, to estimate how many weeks the various pre-clinical tests will require, and if that testing will be conducted in-house or at an outside facility.²

Let’s return to the analogy of building a house. A house is constructed through a series of critical steps. None of those steps can be left out. Most steps must be done in a certain order. A builder must excavate the site before pouring a foundation. One must erect framing before installing the wiring. One needs a roof to protect cabinets and interior finishes. Obviously, some internal or external individual or group must plan and execute each step. Clear roles and responsibilities, along with an accurate project schedule, are critical to the building project.

Similarly, a successful regulatory submission is a compilation of key elements presented in a very structured format. For instance, the FDA guidance on the format of 510(k) applications recommends 20 different sections for a traditional or abbreviated 510(k).³ A regulatory consultant can explain to the development team what is required for each section. And the consultant can build the framework for the submission—a work-in-progress—so the entire team can visualize the various components and the roles they will play. Typically, a project plan (based upon commercially-available project management software) is established in order to fix roles and responsibilities, and to make clear which activities are prerequisites for other activities. For instance, in order to begin bench testing, the engineering team (or external test lab) will require parts. Those parts should be manufactured and documented to the final (specification) configuration, and a design review is necessary to confirm a design freeze.⁴ Each of these steps should be called out in the project plan. The project plan not only brings into focus each activity, or building block, but it provides an overview and schedule of the entire project.

The regulatory submission is, therefore, compiled in a series of building blocks, much like a house. And here is an important point: if the sponsor has prepared (or is in the process of preparing) these building blocks, a regulatory specialist can put them together quickly, assess them, and move forward with the submission process. If, however, building blocks are missing (e.g., test reports, summaries, validation reports, labeling), the project will be delayed while someone is identified to produce those elements.

In summary, business leaders should approach a regulatory project as if they were building a house. Realize the project will require a team of builders. Determine which elements of the team will be in-house members, and which elements will be outsourced. If external regulatory expertise is needed, determine the scope and involvement of that key resource.

Notes/References
¹ For simplicity, this article uses examples typical of the 510(k) process. The metaphor of house construction, however, works equally well for more complicated submissions such as PMAs.
² In order to provide a simple example for this article, we will assume that clinical studies will not be required for this hypothetical device.
³ Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and Food and Drug Administration Staff. Document issued on September 13, 2019.
⁴ An alternative is to conduct the testing “at risk.” This is often costly in both time and money.

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Michael C. Morton is the founder and principal of Michael C. Morton Regulatory Consulting, LLC. The firm provides both strategic and hands-on support to the medical device industry. It specializes in the pre-approval process, including FDA advisory committee meetings, for high-risk devices. The firm is also experienced in a broad range of devices, including digital health, and has also worked in the 510(k), de novo, and HDE routes to market. Morton has over thirty years of experience in the medical device industry, including quality, clinical, and regulatory affairs. His last position was vice president for corporate regulatory affairs at Medtronic Inc., where he was responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy. Before joining Medtronic, Morton worked for CarboMedics Inc., W.L. Gore and Associates, Alcon Labs, and Sorin Group. He has been recognized as a Fellow of the Regulatory Affairs Professional Society (RAPS) and recently completed four years of service on the RAPS Board of Directors. He has been active in industry groups, including the Advanced Medical Technology Association (AdvaMed) where he chaired the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and was a member of the Heart Valve Task Force. Morton represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force and remains interested in current harmonization activities. He has also served as the industry representative to the FDA Circulatory System Devices Advisory Panel.