EdgeOne Medical
Giving Medical Device Developers an Edge

For Lilli Zakarija, EdgeOne Medical is not just a business, but a continuation of heroutstanding 20 years career in the healthcare space. Realizing the deficiency in the market, which included skill shortage and a lack of qualified external service providers for medical device developers and manufacturers, she ventured into the medical device service provider industry. “My intention was to set up a medical device service organization that I was unable to find during my time as Director of Engineering of the BioScience division of Baxter Healthcare,” mentions Zakarija. With this understanding of the unmet need, EdgeOne was established to support all phases of medical device/combination product development. The firm functions as an expert in cross-functional product development and works as an extension of the client’s development team. Many global medical device and biopharma firms have gained success by leveraging the company’s services, which include EdgeOne’s own testing lab, which operates under an ISO 13485 certified and FDA compliant Quality Management System.

Amongst its development support services, EdgeOne provides testing services that include test method development and validation, design verification, and aging studies. Zakarija acknowledges that one of the key differentiators at EdgeOne is they provide testing services using test methods that have been designed and validated around the client’s product with its specific requirements. “We take a leadership role in conducting and coordinating testing efforts while integrating client’s specific product requirements into our deliverables, such that they can be filed directly into our client’s DHF or be included within a submission,” states Zakarija. Their cross-functional understanding strengthens the interdependencies existing within the DHF and connects all the interfacing information together.

EdgeOne is flexible, nimble, and pragmatic and we understand what the customer needs to do and what their end goals are

Be it developing a regulatory strategy, leading a device development program, remediating design control/DHF documentation, or completing verification testing in a lab operating within an ISO 13485 certified quality system, the company understands the full spectrum of the product development lifecycle. As such, they have ability and flexibility to support a device development organization based on its needs enabling their clients to remain focused on their product development and submission deadlines.

EdgeOne’s expertise in medical device development can be better understood by a recent project they undertook. Their client was a large biologics company in the process of developing a biologic for subcutaneous administration. The client’s challenge was to implement and follow the medical device requirements mandated by combination product regulations for their IND submission for Phase II clinical trials. Moreover, the shortage of skilled internal device development expertise and lack of required medical device quality system procedures put the company in dire straits. EdgeOne Medical engaged with client giving them guidance on the device development process. “We helped them understand how to comply with FDA combination product regulations,” recalls Zakarija. Besides providing project management and leadership EdgeOne also supported through test method validation and device design verification testing leveraging their ISO 13485 certified quality system.

“EdgeOne is flexible, nimble, and pragmatic and we understand what the customer needs to do to comply with regulations and what their end goals are,” mentions Zakarija. The firm relies on their experience while addressing some of the unique challenges their clients face. Moreover, they participate in various combination product industry standard committees and conferences, are involved in medical device start-up community as a MedTech Innovator partner, and support new alliances establishing path for digital therapeutics.