Myomo names a new commercial chief whose background is in market access and payer coverage

Myomo, the company that makes the MyoPro powered arm orthosis for people with upper limb motor weakness, named Mary-Katherine McClure as its chief commercial officer. She replaces Micah Mitchell, who will stay through December during the transition.

McClure joins from Inspire Medical Systems, a medical device company, where she worked since 2018. Before that she held senior sales roles at Medtronic, Tobii Dynavox, and Johnson and Johnson. Paul R. Gudonis, Myomo’s board chairman and CEO, framed her hire around three things: building commercial teams, expanding market access, and scaling clinical networks.

“Market access” in medical devices is specific terminology. It means getting a product onto payer coverage policies, building the clinical evidence files that insurers require before covering a device, and negotiating with Medicare and private payers over criteria. Inspire Medical Systems’ implantable sleep apnea device went through years of that work. Getting it covered by Medicare required clinical trials, coverage determination requests, and a long back-and-forth with CMS. McClure spent eight years there.

The MyoPro is a class II prescription device that requires custom fitting by a clinician. Medicare covers it under specific clinical criteria for people with hemiplegia, brachial plexus injury, and certain neuromuscular diagnoses. Private payer coverage has been inconsistent. For people who qualify clinically but can’t get a coverage decision from their insurer, the practical obstacle is usually a payer that hasn’t updated its coverage policy for the device category.

Myomo did not describe what the “next phase of growth” Gudonis referenced will look like in detail. The hire itself is the signal: a CCO with deep payer-coverage experience suggests the company sees coverage expansion as the work in front of it.

What this means

If you’ve been told you might benefit from a powered arm orthosis but your insurer hasn’t covered it, your prosthetist or orthotist is the right starting point. They can document clinical necessity and file the prior authorization. If a denial comes back, the appeals path depends on whether your plan is Medicare, Medicaid, or private, and on what the specific denial reason is. The Amputee Coalition’s insurance resource center and your state’s insurance commissioner’s office are the two external options worth knowing.

A change in commercial leadership doesn’t automatically change coverage decisions. But the background Myomo hired for is the one that tends to move coverage policies over time.