Sleep & respiratory: Set clear expectations

Q. With the rapid changes in respiratory and sleep medicine, what can an HME provider expect from their manufacturing partners?  

A. HME companies may need reassessment of their partnerships with manufacturers. Here’s a framework to guide this process: 

Quality & compliance 

Ensure manufacturing partners comply with FDA, ISO and CE standards. Review FDA 510K status for any restrictions or outstanding recalls. Robust quality assessment and post-market surveillance are essential. The complaints process should be clear and easy.  

Adaptability & responsiveness 

Partners should have open communication channels to address concerns and adapt to market needs. This includes relationships with sales force members, online communication tools, advisory boards, key opinion leaders and participation in HME associations with government advocacy.  

Innovation & technology  

Choose partners with a broad product portfolio and high cybersecurity standards that follow U.S. or international standards. This streamlines onboarding and minimizes cybersecurity risks. Manufacturers should respond quickly to market needs with strong R&D, including remote patient monitoring (RPM) and robust software databases. 

Customer support & training  

Comprehensive technical support and easy communication modes are crucial. FDA guidance expects adequate training to ensure user safety. The complexity of equipment should match the intensity of training provided. While virtual training has greatly improved access, there are still times when in-person training is needed. 

Cost efficiency & supply chain reliability  

With shrinking reimbursement, competitive pricing with transparency is key. It’s essential to balance cost without compromising quality. Evaluate the suitability of devices for your patient population, as the least expensive device in a class may not always meet patient needs. Ensure supply chain reliability and communicate emergency plans upfront. Lastly, assess whether the manufacturer can handle the volume of product your company will need.  

Setting clear expectations, an HME company can ensure a productive relationship with manufacturing partners in the respiratory and sleep industry. 

Colleen Lance, MD, is chief medical officer at React Health. Reach her at Colleen.Lance@ReactHealth.com.