Thomas Hughes, JD works as the senior principal advisor for The Regulatory and Clinical Research Institute based in Minneapolis, Minnesota. His organization works to assist medical device companies pass regulatory steps to sell their product and find paths for reimbursements necessary to fund the medical devices. He stresses that one of the most critical steps in developing a device involves focusing on the reimbursement process.

Top Three Takeaways:

1. Medical device companies must consider the reimbursement process when passing their devices through the regulatory process.
2. Reimbursement is a three legged stool: coding pathway, the payment attached, and coverage are all necessary.
3. The Regulatory and Clinical Research Institute works with a variety of companies—not just startups.

Show Notes:

[00:30] Ladan introduces his guest Thomas Hughes as a medical device consultant who has travelled through many parts of the world—check out Travel Wisdom Podcast to learn more about his travels.

[1:20] Hughes explains his role as senior principal advisor at a clinical research organization called The Regulatory and Clinical Research Institute (RCRI).

[2:40] Hughes describes how he helps organizations get through the regulatory period for their medical devices.

[3:10] Hughes spoke at the forum to explain to medical device companies about how to not only get their devices through regulations, but also acquire reimbursement for them.

[3:45] Startup medical device companies must prove to purchasers that their products should be purchased.

[4:30] Hughes aids companies in understanding how to implement health economics into their products.

[6:00] The design features are critical for a product because it must work well and be disruptive—the medical device must be proven valuable.

[7:15] Medical device companies must research and cater to the financial aspects of their products.

[8:30] Reimbursement is a three legged stool: coding pathway, the payment attached, and coverage are involved.

[10:45] The target groups and codes certain medical technologies must be researched for depends on the type of device.

[13:00] Multiple codes for reimbursement may exist for a medical device.

[13:45] The first step for reimbursement it to look for existing codes; if this does not work, the company may need to take steps in order to create a new code.

[15:00] RCRI does not work with just startups; they work with several large companies still seeking help.

[16:20] Hughes has worked with many startups recently because investors seek to know the landscapes for new medical technologies.

[18:00] Companies may have a great design for their product, but they must think how they will pay for it.

[19:30] Check out Tom Hughes article from October of 2018 in Medical Outsourcing Magazine.