Developing a Regulatory Strategy for Your Medical Device

With tighter regulations from various regulatory bodies around the globe, it becomes even more essential for medical device companies to develop a rock-solid regulatory strategy. You’ll first need to understand and lay out the potential and probable regulatory pathways. This strategy may not be 100% known at the start of the project, and may depend on a variety of factors such as target markets/regions, marketing claims, and testing results.

A lot can go into a comprehensive regulatory strategy to make sure that as much as possible is identified before change gets costly.
Kapstone can help you navigate and prepare this plan by:

  • Identifying key questions to address
  • Understanding requirements in your target markets(s)
  • Developing a schedule
  • Conducting key risk assessments
  • Understanding labeling and testing requirements
  • and more

Kapstone can help you build a regulatory strategy, no matter where or what you want to commercialize. Though navigating the maze of regulatory expectations can seem like a daunting task, you can rest assured with Kapstone on your team. We bring decades of industry-honed experience to each component of your strategy.

Regulatory Assessment

Before embarking on development of a regulatory strategy, sometimes it is appropriate for an assessment of the regulatory landscape to help determine key objectives. This may be included as part of a feasibility study or a new product development project, or it could be a standalone assessment before starting larger efforts.

The main goal of the regulatory assessment is to get an idea of the device class (e.g. in the US class I, II, or III), potential submission pathway (e.g. 510(k) vs De Novo), potential product codes, potential predicates (if applicable), and a draft of the indications for use statement.

US FDA Pre-Submission

For the US market, Kapstone typically suggests holding a pre-submission meeting with FDA, the customer, and Kapstone. This method enables early interaction with FDA before the product development process gets too far along and enables medical device manufacturers to ask questions and propose a path forward on strategies that oftentimes implement innovative elements.

Our experience is that this can help smooth out FDA issues that may otherwise be brought up in a later (and more expensive) stage of the project. Decreased risk of significant requests in an FDA Additional Information request are observed when companies work with Kapstone on an FDA pre-submission.

Building the Regulatory Strategy

Compared to a regulatory assessment, the strategy (aka plan) for the regulatory pathway of a new product (or product to a new market) is much deeper in scope and should take into account:

  • Intended use of the product
  • Markets the product will be sold (and therefore regional requirements)
  • Anticipated risks
  • Testing requirements per harmonized standards or special controls
  • Claims on performance of the device
  • Specific requirements for the device
  • and more

Intended Use

The first and arguably most important part of building a regulatory strategy is to hone in on your device’s intended use. Who exactly is it for—providers or patients? What condition(s)? What use case? What problem does it solve? Does it fulfill an unmet patient or provider need? Many companies have a good answer to one or two of these questions, but fail to consider all of them.

Global regulatory bodies will require you to clearly demonstrate your product’s intended use. Plus, determining which types of testing and review you’ll need, and when, will depend on what you intend to accomplish with your device. Identify the answers to these questions as early as possible so that you can begin to map out a corresponding regulatory strategy. If you don’t know where to start, Kapstone can help. 

Targeting Global Markets

Your regulatory strategy will look different depending on where and how you want to commercialize your product. The US, EU, and other global regulatory markets require different documentation and testing activities that you’ll need to plan for. Kapstone can help you decipher these confusing, ever-changing regulatory requirements and establish a plan that’s optimized for your commercialization goals.

Anticipating Risks

Regulatory bodies’ primary function is to reduce or eliminate risk to the consumer. In order to comply with their requirements and commercialize your products, you’ll also need to take a conservative approach to risk.

Consider these risk categories when developing your regulatory strategy:

  • Whether or not you’re setting a new regulatory precedent with your device
  • Whether your device serves a new patient or user population
  • Your device’s potential for off-label use and how you’ll mitigate it
  • The likelihood of adverse events and malfunctions, and how you’ll handle reporting
  • Potential need for post-approval studies
  • And more

Kapstone has successfully brought dozens of products to market across the globe. We are experts in both risk anticipation and mitigation, and can act as your go-between with regulatory bodies to ensure approval and ongoing compliance.

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