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The good, the bad and the senseless. How to create a winning regulatory strategy.

There is no doubt about it, the healthcare industry is evolving. With this evolution comes increased regulatory scrutiny for today’s medical device companies. In the last few years alone, several big players in the industry including Theranos and Custom Ultrasonics have been hit with warning letters, endured product recalls or found themselves operating under FDA consent decree. In parallel, the pressure for growth and innovation has never been greater. This is fueled by the emergence of smart, connected technologies, user-focused products developed for in-home use and growing competition from start-ups and consumer companies like Apple and Google. Today, the industry is challenged in designing and developing products that are not only digital and innovative but also compliant to FDA regulations and requirements.

It’s an all too typical scenario: the development of your latest device has begun, gains momentum and before you know it, the pressure is on to get it to market.  But small details that you breezed over months earlier now become insurmountable stop-gaps to get to market.

As the regulatory environment becomes increasingly complex, medical device companies can no longer rely on duplicating previously successful strategies for any new product. Instead, they will be challenged to develop regulatory strategies that include short and long-term objectives, like future secondary indications or target markets, a complete summary of all technical and clinical testing requirements and the requirements of all stakeholders.

But a good regulatory strategy answers more than just, “what and where do I need approval?” It is a living strategy that – if done correctly – can help facilitate fast and proactive decision-making during the late stages of R&D by determining key inputs and outputs, what design verification and validation testing should be completed and post-market surveillance plans.

Three key considerations for your regulatory strategy plan:

  1. Intended use(s) and desired marketing claims

What do you want your product to do? Answering this question sounds simple, right? But the truth is it’s a lot trickier than it may seem. As you can imagine, the list of potential intended uses are huge and the differences between them may be minor. But the slightest difference can have a profound impact on the regulatory consequences.

For example: you can market a surgical clamp with the intended use of temporarily stopping the flow of blood. Or, you could market the same clamp claiming it is useful in mitral valve replacement surgery. While the basic use of the clamp is the same in both cases (stopping blood flow), the FDA considers one to have a higher inherent risk than the other.

This example – albeit simple – demonstrated the criticality of determining your intended use(s) up front. The intended use(s) dictates the regulatory pathway, whether it be PMA, 501(k), De Novo, HDE, PDP, CDE and Expanded Access (or any combination of them), which all support these claims with data gathering throughout product development. There are advantages and disadvantages to each approach but deciding in advance will help define your budget, timeline and test plans for your product.

  1. Target Markets

The healthcare industry is full of regulations. These can range from completely sensible guidelines to rules that are archaic and utter nonsense. But at the end of the day, as a medical company it is up to you to understand these regulations and comply with them – for each and every country you plan to market your product in.

In the increasingly global medical device market, sifting through varying regulations, directives and guidelines can be a daunting task. Even as regulations become more consistent across the globe, some very specific local requirements are significant enough to shape your entire strategy. These can be as small as the need for certain translations on packaging, or as complex as the structure of your entire clinical trial.

For instance, if you intend to market your ETO sterilized device in Japan, complying to FDA and global standard ISO 10993-7 isn’t enough. Complex registration and regulatory processes make Japan one of the most time consuming markets to enter; your marketing department isn’t going to be happy when they can’t ship the product because you missed something. Together with intended uses, your target market specifications are going to provide you with the guidance and standards you will need to build your regulatory strategy around. Taking this step first will not only save you time and money, but will also result in a faster approval and time to market.

  1. User Requirements

Design for your users. We cannot stress this enough. The fact is that many medical device companies still follow a top-down, waterfall approach to development vs. an agile, feedback-driven cycle. In this type of environment where technology is king, the customers and how they will interact with the product usually takes a back seat. So how does designing for your user translate to your regulatory strategy?

Your goal is to complete a successful design validation study for the FDA, with one of the most important objectives being getting approval that it is safe to use. But, without identifying your user requirements, including safety related functions as well as human factors (IEC 62366-1:2015) you cannot ensure that your design input is completed correctly. And if your product is designed poorly, not only will it not meet regulations but once it finally reaches the market, no one will be opening their wallets to buy it.

The medical device regulatory market is a maze of rules and requirements. But the FDA would prefer (just as much as you) to have everything done right the first time as they have their own goals to meet. Your best bet is to use advanced planning and leverage regulatory experts to sort through all of the clutter and create a solid regulatory strategy….and then get that product on the market!


Jackie Torfin
Vice President, Quality Assurance


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