
With President Donald J. Trump’s second term underway and new leadership expected to take over FDA and CMS, we sought perspective on important issues that could affect orthopedic companies in the near term. We reached out to Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), to learn what initiatives the group is watching and advocating for on behalf of their members.
When we spoke, key officials were awaiting confirmation hearings. Robert F. Kennedy, Jr. has been nominated to serve as Secretary of the Department of Health and Human Services. John Hopkins surgical oncologist Martin Makary, M.D., has been tapped to run FDA, and physician and TV personality Mehmet Oz, M.D., has been nominated to run CMS.
“I think it’s noteworthy that you have two physicians who have treated patients and worked with early stage medtech companies nominated to run FDA and CMS,” Mr. Leahey said. “I think those are positive attributes.”
We spoke with Mr. Leahey on a wide range of topics associated with the two agencies, as well as the Trump administration’s policy priorities. He said that biocompatibility, coding coverage and prior authorization restrictions are key issues for MDMA members within the orthopedic community.
Our conversation has been edited for conciseness and brevity.
What legislative or policy changes are you watching from the Trump administration?
Mr. Leahey: The gap between when FDA authorizes a product and when it receives adequate coding coverage and payment is a challenge. Trump’s first administration took significant steps to address this issue, and we look forward to working with the new administration and Congress in a bipartisan way to narrow that gap between regulatory and reimbursement initiatives.
Taxes and tariffs are priorities for the Trump administration, but there’s uncertainty about which sectors might be impacted. How might such changes impact the medical device industry?
Mr. Leahey: There is uncertainty. The key issue on tariffs is that the U.S. is the world leader in medical technology innovation. Most companies based in the U.S. manufacture in the U.S. and abroad, serving multiple markets. Our perspective is that broad based tariffs are likely to impact the ability of many U.S. companies to invest in R&D at home. We’re in the early stages but diligently assessing the landscape.
The Trump administration has talked about lowering the tax rate or providing a credit to U.S. companies that manufacture here. We’ll have to watch how these issues evolve.
Dr. Michelle Tarver recently took over as Director of CDRH, and other leadership changes will take place at FDA soon. What changes at FDA are you following?
Mr. Leahey: Manufacturers, including orthopedic companies, face ongoing challenges. FDA and industry have spent a lot of time, energy and resources on biocompatibility efforts that are not advancing patient care.
I call myself the plumber because people only call me when things get stuck. The number one issue for which companies reach out to me regarding FDA is unnecessary inconsistency in biocompatibility testing. There is an appreciation that biocompatibility needs to be part of the totality of evidence and overall benefit/risk framework in a device submission. We hope that FDA addresses these biocompatibility concerns and reduces their inconsistencies. The agency held a public meeting at the end of 2024 to discuss the topic, so there is a greater awareness of the problem.
Looking at the broader picture, we’re paying a historic amount in medical device user fees. Also, FDA has not been able to backfill agency members who are retiring. We want to understand these issues better to ensure that we have the increased capacity to drive more predictability and transparency, while maintaining the gold standard of patient access to safe and effective products in a timely manner.
One of MDMA’s key issues is AI, a topic that is receiving considerable attention today. How are you advocating for this issue?
Mr. Leahey: MDMA has an AI working group focused on this area. The first AI-enabled medical technology was authorized 30 years ago, and now over 1,000 medical technologies with AI elements are authorized by FDA. There’s a lot of confusion between AI-enabled medical devices and software as a medical device, which are regulated by FDA, and broader AI in healthcare, which has less oversight.
Our primary focus is educating and highlighting the fact that we’ve been on this journey with FDA for three decades. We don’t want additional layers of a new government agency on AI or new requirements on top of what already is working very well with CDRH.
What should orthopedic leaders consider in the short and long terms relative to AI regulations?
Mr. Leahey: You’ll often hear FDA say they need more tools in their toolbox. I look at it as a three-pronged approach. Step one: If you believe there are gaps in the regulatory paradigm or process, cite those gaps with specificity. Step two: Identify what targeted, additional authorities are needed to fill the gaps. Step three: Lay out evidence that shows the specific proposed tools will address the underlying issue.
We have yet to find a situation in which our member companies feel that the FDA regulatory toolbox is insufficient. We’re open to discussions, but the default shouldn’t be that novel technologies need new systems and authorities.
There are also challenges on the payment side. Reimbursement rates are typically predicated on several factors, including labor intensity. If we’re prioritizing value over volume, there are AI-enabled technologies that provide real value. There’s a significant investment in computing power and analysis that provides quality to the system. However, these technologies don’t always have a heavy labor component, which could drive down the overall payment rate.
We want incentives in place that capture the value and investment that companies make in data computing and analysis when payment rates are set.
What other key areas should orthopedic companies watch in 2025?
Mr. Leahey: Site-neutral reforms and payments. There’s interest in exploring a harmonized payment rate no matter the care setting. Folks have criticized large integrated hospitals for moving patients to the most profitable site for treatment, but device manufacturers usually have fixed price points. If these discussions continue, we want to make sure that there’s an appreciation for patient complexity and efficiency in overhead for certain operations while recognizing that device costs are often fixed.
We are hopeful that we can get accelerated coverage for novel technologies across the finish line in this next Congress. Some innovative orthopedic technologies may not have existing coding coverage and payment but provide clinical benefits to patients. We want to decrease the time between when a product receives FDA market authorization, adequate reimbursements and CMS coding, coverage and payment.
Congressional support has also grown regarding the overuse and abuse of prior authorization. Insurance companies are hiring third parties like Carelon and EviCore to put restrictions on existing coverage policies. There is little transparency into how these third parties are operating and what evidence they’re reviewing. Our mission is to ensure that patients have timely access to safe and effective products. If there are examples of friction to that access, we want to hear from our members, figure out where those pain points are and smooth them over.
With President Donald J. Trump's second term underway and new leadership expected to take over FDA and CMS, we sought perspective on important issues that could affect orthopedic companies in the near term. We reached out to Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), to learn what initiatives the...
With President Donald J. Trump’s second term underway and new leadership expected to take over FDA and CMS, we sought perspective on important issues that could affect orthopedic companies in the near term. We reached out to Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA), to learn what initiatives the group is watching and advocating for on behalf of their members.
When we spoke, key officials were awaiting confirmation hearings. Robert F. Kennedy, Jr. has been nominated to serve as Secretary of the Department of Health and Human Services. John Hopkins surgical oncologist Martin Makary, M.D., has been tapped to run FDA, and physician and TV personality Mehmet Oz, M.D., has been nominated to run CMS.
“I think it’s noteworthy that you have two physicians who have treated patients and worked with early stage medtech companies nominated to run FDA and CMS,” Mr. Leahey said. “I think those are positive attributes.”
We spoke with Mr. Leahey on a wide range of topics associated with the two agencies, as well as the Trump administration’s policy priorities. He said that biocompatibility, coding coverage and prior authorization restrictions are key issues for MDMA members within the orthopedic community.
Our conversation has been edited for conciseness and brevity.
What legislative or policy changes are you watching from the Trump administration?
Mr. Leahey: The gap between when FDA authorizes a product and when it receives adequate coding coverage and payment is a challenge. Trump’s first administration took significant steps to address this issue, and we look forward to working with the new administration and Congress in a bipartisan way to narrow that gap between regulatory and reimbursement initiatives.
Taxes and tariffs are priorities for the Trump administration, but there’s uncertainty about which sectors might be impacted. How might such changes impact the medical device industry?
Mr. Leahey: There is uncertainty. The key issue on tariffs is that the U.S. is the world leader in medical technology innovation. Most companies based in the U.S. manufacture in the U.S. and abroad, serving multiple markets. Our perspective is that broad based tariffs are likely to impact the ability of many U.S. companies to invest in R&D at home. We’re in the early stages but diligently assessing the landscape.
The Trump administration has talked about lowering the tax rate or providing a credit to U.S. companies that manufacture here. We’ll have to watch how these issues evolve.
Dr. Michelle Tarver recently took over as Director of CDRH, and other leadership changes will take place at FDA soon. What changes at FDA are you following?
Mr. Leahey: Manufacturers, including orthopedic companies, face ongoing challenges. FDA and industry have spent a lot of time, energy and resources on biocompatibility efforts that are not advancing patient care.
I call myself the plumber because people only call me when things get stuck. The number one issue for which companies reach out to me regarding FDA is unnecessary inconsistency in biocompatibility testing. There is an appreciation that biocompatibility needs to be part of the totality of evidence and overall benefit/risk framework in a device submission. We hope that FDA addresses these biocompatibility concerns and reduces their inconsistencies. The agency held a public meeting at the end of 2024 to discuss the topic, so there is a greater awareness of the problem.
Looking at the broader picture, we’re paying a historic amount in medical device user fees. Also, FDA has not been able to backfill agency members who are retiring. We want to understand these issues better to ensure that we have the increased capacity to drive more predictability and transparency, while maintaining the gold standard of patient access to safe and effective products in a timely manner.
One of MDMA’s key issues is AI, a topic that is receiving considerable attention today. How are you advocating for this issue?
Mr. Leahey: MDMA has an AI working group focused on this area. The first AI-enabled medical technology was authorized 30 years ago, and now over 1,000 medical technologies with AI elements are authorized by FDA. There’s a lot of confusion between AI-enabled medical devices and software as a medical device, which are regulated by FDA, and broader AI in healthcare, which has less oversight.
Our primary focus is educating and highlighting the fact that we’ve been on this journey with FDA for three decades. We don’t want additional layers of a new government agency on AI or new requirements on top of what already is working very well with CDRH.
What should orthopedic leaders consider in the short and long terms relative to AI regulations?
Mr. Leahey: You’ll often hear FDA say they need more tools in their toolbox. I look at it as a three-pronged approach. Step one: If you believe there are gaps in the regulatory paradigm or process, cite those gaps with specificity. Step two: Identify what targeted, additional authorities are needed to fill the gaps. Step three: Lay out evidence that shows the specific proposed tools will address the underlying issue.
We have yet to find a situation in which our member companies feel that the FDA regulatory toolbox is insufficient. We’re open to discussions, but the default shouldn’t be that novel technologies need new systems and authorities.
There are also challenges on the payment side. Reimbursement rates are typically predicated on several factors, including labor intensity. If we’re prioritizing value over volume, there are AI-enabled technologies that provide real value. There’s a significant investment in computing power and analysis that provides quality to the system. However, these technologies don’t always have a heavy labor component, which could drive down the overall payment rate.
We want incentives in place that capture the value and investment that companies make in data computing and analysis when payment rates are set.
What other key areas should orthopedic companies watch in 2025?
Mr. Leahey: Site-neutral reforms and payments. There’s interest in exploring a harmonized payment rate no matter the care setting. Folks have criticized large integrated hospitals for moving patients to the most profitable site for treatment, but device manufacturers usually have fixed price points. If these discussions continue, we want to make sure that there’s an appreciation for patient complexity and efficiency in overhead for certain operations while recognizing that device costs are often fixed.
We are hopeful that we can get accelerated coverage for novel technologies across the finish line in this next Congress. Some innovative orthopedic technologies may not have existing coding coverage and payment but provide clinical benefits to patients. We want to decrease the time between when a product receives FDA market authorization, adequate reimbursements and CMS coding, coverage and payment.
Congressional support has also grown regarding the overuse and abuse of prior authorization. Insurance companies are hiring third parties like Carelon and EviCore to put restrictions on existing coverage policies. There is little transparency into how these third parties are operating and what evidence they’re reviewing. Our mission is to ensure that patients have timely access to safe and effective products. If there are examples of friction to that access, we want to hear from our members, figure out where those pain points are and smooth them over.
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Carolyn LaWell is ORTHOWORLD's Chief Content Officer. She joined ORTHOWORLD in 2012 to oversee its editorial and industry education. She previously served in editor roles at B2B magazines and newspapers.