November 30, 2020
A startup in Champaign will soon be positioned as an internationally certified Medical Device manufacturer thanks to certification made possible by East Central Illinois workNet. Medical device company PhotoniCare plans to pursue certification through the Medical Device Single Audit Program (MDSAP) in hopes of opening significant new sales opportunities. An Incumbent Worker Training program funded by East Central Illinois workNet will help the company’s employees complete that certification and expand their expertise.
PhotoniCare designs and manufactures a device called the TOMi Scope (pictured above), an imaging device that allows doctors to see whether fluid is present behind the ear drum and make more informed decisions regarding ear infection diagnosis and treatment. At the beginning of 2020 the company received FDA approval to market the TOMi Scope and in response they built out a manufacturing facility to produce it, with plans to continue growing their manufacturing capacity to meet increasing demand.
In order to expand internationally, grow their sales, and diversify against market disruption, PhotoniCare needs to complete the MDSAP, which is required for international approvals and makes the TOMi Scope compliant with the regulatory systems of the United States, Canada, Brazil, Japan, and Australia. PhotoniCare already has an exclusive distribution agreement with a company in Japan and is ready to move into the market there once the necessary approvals have been obtained.
“We also have contacts in Canada and Australia, who are excited about the product and want to be able to purchase it,” explains Heather Howard, PhotoniCare’s Director of Manufacturing. “These areas are recovering more quickly than the United States from the recent economic shocks and having sales opportunities in multiple countries may also help PhotoniCare maintain sales during market disruptions.”
The Incumbent Worker Training will enable PhotoniCare employees to create and maintain a quality system that is fully compliant with the MDSAP regulations, allowing the company to expand its assembly workforce and make sure that every device built is made to the highest quality standards. These skills will give PhotoniCare’s employees job security and increased responsibilities, critical elements that will ensure the future success of the company.
Howard says these skills are very in-demand in the medical device industry, so they could also serve employees well in future roles at other companies in the community. Meanwhile, expanding sales internationally will allow PhotoniCare to grow its manufacturing capabilities in Illinois and to potentially hire several new employees to support those efforts, including assembly and support team associates. In addition, there will be expanded opportunities for community-based suppliers of products and services.
“The Incumbent Worker Training funded by East Central Illinois workNet creates an excellent opportunity for training investment in our employees,” Howard concludes. “It will increase their skills and help PhotoniCare grow and emerge successful from the impact of COVID-19.”
The MDSAP training was approved in late July 2020 and is expected to last through the end of December. Due to COVID-19, the training is taking place online and is being conducted by the Illinois Manufacturing Excellence Center (IMEC). Once completed, PhotoniCare employees should have a comprehensive understanding of the MDSAP certification requirements and the skills required to implement management reviews and internal audits, perform effective risk assessments and corrective action, and evaluate potential registrars.
Founded in 2013, PhotoniCare aims to make a real impact on the health of children by revolutionizing healthcare. The TOMi Scope was designed to improve on significant shortcomings seen in many current diagnostic tools and techniques. Incumbent Worker Training, like the MDSAP certification training funded by East Central Illinois workNet, helps companies train their existing employees, increase productivity, and boost a company’s competitiveness by addressing skill gaps in its existing workforce and averting layoffs.