I have an opportunity to conduct a post-conference workshop at this year’s Healthcare Unbound conference. This year’s event is in San Diego, July 11-12 at the Manchester Grand Marriott. The title for the workshop is, Developing a Regulatory Strategy for Your Healthcare Unbound Product. The workshop will be conducted the afternoon of July 12th. You can read the workshop description at the end of this PDF document.

The rationale behind the workshop is the need to clear up confusion on the part of many product developers regarding regulatory issues like,

  • Is my product a regulated medical device?
  • What does it mean to be regulated?
  • If I don’t want to be regulated, can I avoid regulation – and if so, how?

Ideally, we can structure the workshop around attendees actual products and situations. This, of course, will depend on folks registering in advance with sufficient lead time to actually prepare some content around their unique situations. Using participant’s products as case studies should be more engaging and relevant for everyone. If you’re registered for the workshop and want to provide a case study, let me know by completing this contact form.

If we can’t get participant provided cases, I plan to use some example products from companies like AirStrip Technologies, MIM Software’s Mobile MIM, and MobiSante’s MobiUS ultrasound product.  I’m also open to suggestions about other companies or products for case studies (again, leave your thoughts on the contact form.

Like any other business activity, if you want any hope of meeting your objectives, you need a plan. The same holds true regarding regulatory issues, whether you want to avoid or embrace being regulated by FDA. The objective of the workshop is to lead you through the process of putting together a plan.

Here are the topics I’m pulling together for the workshop. The first issue is whether your product as it exists or is conceived meets the legal definition of a medical device. For those outside the regulatory field, the answer to this question is both simpler and more complex than many think. We’ll look at the typical artifacts and indications for making this determination.

Next we’ll work to bring into focus the boundaries between what makes a product a regulated medical device or not. You will find that the degree of focus will vary depending on the nature and characteristics of the product. We will then consider what would be necessary for the product to move from being regulated to unregulated and vice a versa.

The most basic decision in your regulatory strategy is whether or not your product will be regulated. Once we’ve worked that out, we will develop a plan to realize your strategy. This plan will focus mostly on your product roadmap, sales and marketing. We’ll define the strategy as it will be applied company operations, to include clearly defined product feature boundaries, a defined claims and intended use framework, and a few other components. In cases where the strategy entails being regulated, we’ll include those requirements in the plan as well.