- September 1, 2016
- Posted by: Cheryl Rybka
- Category: Quality
“Ampcare Creates Device to aid Patients with Dysphagia”
Headquartered at TECH Fort Worth, Ampcare developed a therapeutic neuromuscular electrical stimulation technologies which includes the Ampcare ESP™ (Effective Swallowing Protocol), a FDA-cleared medical device system. The Ampcare ESP™ is an innovative protocol for the treatment of dysphagia (swallowing difficulties). The Ampcare founders are committed to delivering positive patient outcomes and innovative products specially designed to meet the needs of the patient, medical professional and the payer. Ampcare’s vision is to eliminate pneumonia and feeding tubes due to swallowing problems by improving the options and availability of dysphagia treatment techniques.
Ampcare applied for FDA clearance for their device, the Effective Swallowing Protocol, but the supplier of a key component, the powered muscle stimulator, was unable to meet the requirements for FDA clearance. Without this critical FDA-cleared component, Ampcare could go no further. TECH Fort Worth setup the initial meeting between Ampcare and TMAC to discuss Ampcare’s needs and whether TMAC was the right organization to assist in finding a new supplier / partner.
Using Tech Scouting – a technique that originated by the Research Triangle International / Institute (RTI) – TMAC conducted a supplier scouting project to find potential suppliers / partners of the component. A key concern was for the potential supplier / partner to be an FDA registered manufacturer of electrical muscle stimulators and to have successful experience in receiving FDA clearance of these devices. TMAC conducted the search which unmasked 69 potential suppliers / partners. Following Ampcare’s criteria, the list was reduced to 11 potential suppliers. Ampcare chose the top three that they wanted TMAC to investigate more thoroughly. TMAC prioritized the list based on findings by the FDA, size of the company, history, etc. Contacts at the companies were forwarded to Ampcare to start the negotiations and discussions.
Ampcare received FDA clearance for the Effective Swallowing Protocol. In addition to having an FDA cleared device, Ampcare is proud to be able to improve the health status and quality of life for individuals with dysphagia.
Ampcare was accepted to present their research and protocol at the American Congress of Rehab Medicine in Chicago, October 2016. They currently have 2% market penetration in the United States for training on this medical device. Internationally, they have presented at the UK Swallowing Research Group (UKSRG) in London in February 2016, and plan to launch their product in October 2016 following training in Sheffield, England. In Hong Kong, a total of 111 Speech and Language Pathologists have been trained out of 400 for 28% market penetration. In June 2016, Ampcare will present to the Japanese Association of Rehab Medicine (JARM).