Most applications for chronic care are largely non-reimbursed and tend to be considered ‘consumer’ Class I FDA devices, though there are exceptions such as consumables for the treatment of Diabetes Mellitus or devices for proof of compliance.
Chronic care devices do need to offer connectivity for provisioning and monitoring of the patient. Solutions for FDA Class I devices however tend to be price sensitive, compared to Class II/III. The requirements for the latter in Acute and RUO (Research Use Only) products are radically different.
As an example, where BER/FER rates for consumer devices of 3-5% might be acceptable for a consumer Class I device, that would be intolerable for a Class II/III device intended for in-hospital deployment. Product specifications, documentation, process management, engineering, manufacturing and deployment are all set to a much higher standard with devices that are deployed in life/death situations. Latency is a much more important parameter for acute care applications, than for example throughput or range. While all these factors set essential design constraints, trade-offs in total system implementation is what sets RTX apart.
RTX has built years of expertise in the design and manufacturing of devices that are intended for these more specialized and challenging markets.
From wireless systems that monitor critically ill patients to hearing aid accessories, we have the experience, technology and industry understanding to help you conceive, design and manufacture unique wireless devices.
Contact us at Design Services to learn more