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LumiThera
From Prototype to Approved Ophthalmic Medical Device
Photobiomodulation (PBM) involves the use of visible or near infrared light (NIR) produced by a laser or a non-coherent light source applied to the tissue of the body to provide beneficial effects in a wide range of disease states. It is widely used in physiotherapy, chiropractic and sports medicine, and increasingly, recognized as a potential therapy for the treatment of severe and life-threatening disease states.
LumiThera, Inc. was created in 2013 to develop and commercialize an early treatment for ocular damage or disease using Photobiomodulation (PBM). Two of the founders were doctors, two were engineers, and the fifth founder was company President and CEO, Clark E. Tedford, a Ph.D. in neuropharmacology.
The Challenge
“We brought StarFish a device that was prototyped and had gone through some of the early clinical data. It still needed additional work to get it to the point of a commercial instrument.”
How StarFish Helped
StarFish identified technical risks associated with manufacturing the design “as is,” addressed unknown issues that are typical of all new products, and ensured the product was developed, documented and built in a 13485 certified QMS system and FDA registered facility.
While working on the transfer, StarFish completed the specification documentation and assisted with regulatory submissions (BSI for CE Mark).
- Refined and detailed product requirements and specifications to support commercial requirements
- Worked with LumiThera engineering to resolve technical issues as they arose
- Developed production documentation
- Resolved pre-production technical issues
- Conducted verification testing
- Implemented and finalized traceable development and production documentation via ISO 13485 certified QMS system. Successfully supported regulatory submissions and audits
The Results
- Commercial units are now ready for sales
- CE mark acquired
- A path forward defined for Health Canada and FDA
LumiThera is in the process of seeking regulatory approvals and globally expanding the treatment around the world.
Client: LumiThera, Inc
As we moved forward, we recognized that our design house didn’t have the later-stage development quality and manufacturing capabilities required for a medical device. We needed to find a partner who could take us to the next stage of commercialization. StarFish Medical could put the final touches around the instrument and create a manufacturing piece as well.
Clark E. Tedford
LumiThera President and CEO