Do you think your product could be a regulated medical device?
There are all kinds of regulatory strategies. Any new product development project for a regulated product should have a regulatory strategy that optimizes requirements, specifications, risk and verification testing, especially as it relates to the off the shelf components of a medical device. I would call this a product-specific regulatory strategy.
At the other end of the spectrum, a company should have a regulatory strategy that charts the regulatory course of the company in addition to its relevant products. Companies already regulated by FDA should have one of these as part of their management responsibilities - and it should be kept up to date as products, the company, and the regulatory environment change over time. Let's call this a corporate regulatory strategy.
You especially need a corporate regulatory strategy if your company's products, or the products of companies you see as direct competition, are in that gray zone that could maybe be interpreted as a regulated medical device.
Sadly, there is no one unambiguous line that a product has to cross to be a regulated medical device. Clearly an implanted heart valve replacement or patient monitor is a medical device. The definition of a medical device is unambiguous, but so general as to encompass a lot things that are not currently regulated by FDA.
A good example are Medical Device Data Systems (MDDS) - this market has existed since the 1980s, yet it wasn't until earlier in 2011 that FDA signaled enforcement discretion, reclassified the product, and gave manufacturers a schedule to come into compliance. Up until this year, most MDDS were not regulated. There are other markets where FDA is pursuing regulatory discretion (i.e., looking the other way), giving a market segment time to mature, and for FDA to learn more about the product category - the risks to patient safety, its use by providers or patients, and developing ideas on how best to regulate when the time comes.
If your product and company are in this gray area, whether you feel you should be regulated or want to avoid regulation, you need to know where you stand and have a plan. Otherwise, you're just winging it.
In this case, the regulatory strategy has 3 objectives:
- Get a clear reading of where your product(s) stand relative to FDA regulation, by identifying boundaries and specific features or claims related to your product(s) that make a device regulated or not.
- Make an informed strategic decision to either be a regulated manufacturer, or not.
- Develop and implement a strategy based on your decision from step 2.
Let's look at each step in detail.
Regulated or Not?
Step one is to describe the regulatory boundaries around your product(s) and market. This includes applying the definition of a medical device to your product, looking at the claims or intended use of your product, how your product is used by customers, considering competitors and similar products. While technology is a consideration, more important factors are patient safety risk (direct and indirect), and the marketing claims made about the product. Evaluating the market means looking to see if any competitors are regulated, and if so, how? You also want to consider market requirements and where the market is evolving - is this evolution getting closer to the point of care?
An attorney could spend six figures researching the above and the relevant case law - and in some situations that is what's needed. But for most companies this assessment is less ambiguous or complex. The end product will be talking points based on research that you would want to have should someone from FDA walk in your offices, flash a badge and start asking questions.
To Be Regulated or Not?
The answer to this question is often not as clear cut as it seems, especially if your motivation is to avoid regulation. Regardless of your initial preferences, this phase entails a decision making process that takes the output of the first phase and applies filters, for example:
- What's the likelihood FDA will regulate your product in the foreseeable future?
- How would your product and its market claims change if they were regulated or unregulated?
- What are the tactical and strategic advantages of being regulated and not regulated?
- What are the risks and associated costs of being regulated or not?
The decision to be regulated or not is based on information generated by the questions above.
Crafting a Regulatory Strategy
It is important to have a regulatory strategy whether you decide to be regulated or unregulated. Should you decide to be regulated, your strategy is geared towards becoming regulated and how you position your product from a regulatory perspective for maximum competitive advantage, lowest cost, and shortest time to market (or through regulatory hurdles). If you decide to not be regulated, your strategy defines all the things you must do to actively avoid regulation.
Depending on your situation, the actual implementation of the strategy can vary greatly. If you're putting yourself on the path to be an FDA regulated manufacturer, you will want to do another layer of implementation planning and you probably have a substantive implementation effort ahead of you, say 6 to 12 months of work, or more.
If your strategy is to avoid regulation, the critical part is defining the boundaries you plan to maintain to avoid regulation, and making sure everyone in your company knows their part in successfully executing the strategy. Training employees (especially, product development, marketing, sales, installation and service staff) is key to successful implementation of your regulatory strategy.
Once you have your strategy in place, you'll want to keep it up to date. A relevant announcement by FDA could trigger a reassessment of your strategy, as could a competitor submitting a product for regulation. Should one or more customers start using your product in a way that transforms it into a medical device is another potential trigger point for a reevaluation. In most cases though, taking a half day to do an annual review of the strategy and relevant internal and external changes should be sufficient.
If you're in need of a regulatory strategy, let me know.
Thanks for the article. What does not make sense is the FDA trying to regulate software systems that only move data, MDDS. A simple checksum will guarantee that data has not been altered in transmission. TCP-IP is also a robust system for guaranteed delivery of data. The other strange thing is that the FDA is concerning themselves with systems like MDDS but not EHR or medical calculators used by providers and patients.