EdgeOne Medical
A Reliable Partner for Medical Device Development

Lilli Zakarija, a 20-year healthcare veteran in the industry, fondly remembers founding her company EdgeOne Medical that provides critical support throughout the development and life cycle management of medical devices/combination products. Interestingly, she told us that the company was founded as a result of one simple yet insightful observation. Lilli noticed that medical device developers and manufacturers were keenly focused on product design and production, however when they relied on external service providers for other processes, such as verification testing, there was a lack of capable service providers available that understood the context of their activities within the full design control process. Those service providers offered either transactional services, or they expected the client to train them on how to do it.

Realizing the need to offer integrated services for successful product development, EdgeOne Medical was established in 2012. Since then, more than ten of the top 50 Global Medical Devices and Biopharma firms have gained an edge utilizing the company’s device development services. Founded with a small team of industry experts, EdgeOne has seen significant organic growth to more than 20 team members today. To support the increasing demand for services and to accommodate the addition of several highly experienced leaders to the team, the company recently shifted its headquarters to a new 20,000 sq.ft facility. “Our growth is an opportunity to provide our clients with more and better services,” says Lilli Zakarija, cofounder and president of EdgeOne Medical.

Giving Medical Device Developers an Edge

With unwavering passion and commitment to bring innovative life-enhancing medical technologies to market, EdgeOne helps its clients at every step of the process. Led by product development professionals, the company provides an ISO 13485 certified and FDA compliant Medical Device Testing Lab that can operate according to global requirements. The company offers an array of product testing services for the entire product development process, including early testing for key performance characteristics, test method development and validation, verification and aging testing, and Design of Experiments (DOE) for determining design features sensitive to proposed manufacturing process conditions. Further, the company provides cross-functional product development experts who work as an extension of the client’s team and resources designed for the development life cycle. “We guide our clients through the device development process to quickly reach the finish line, accurately and compliantly. As a values-based company, our vision is to be the cartographer for a better healthcare future,” Says Lilli. She added, “We admit to being a bunch of talented geeks that love what we do and love being part of improving products that serve patients.”

Apart from its testing services, clients utilize the diverse capabilities of EdgeOne in the product development lifecycle, including quality management, regulatory needs, remediation, and project management. Whether its developing regulatory strategy or quality solutions for unique business goals, the company effectively navigates its clients through the device development process. This enables the clients to engage with a single entity to fulfill all their needs rather than relying on multiple vendors. Lilli highlighted an instance where EdgeOne was engaged with a client for design control and testing of a combination product. The client then needed support on regulatory requirements and technical documentation for the European market. With the EdgeOne team’s in-depth knowledge of European regulations, they were able to understand the context and seamlessly fulfill their additional needs.

Our growth is an opportunity to serve our clients with more and better services

Being One-of-its-kind in the Market

Lilli told us that most of the clients prefer EdgeOne Medical because they are independent of the product designers or any other workstreams involved. Without involvement and being invested in the design process, EdgeOne analyzes the product’s performance adhering to the client requirements from a fresh perspective. The company’s leadership is cross-trained from development to commercialization, ensuring that the design development documentation and product requirements are met. “We understand and respect the key players in the development process while importantly staying independent,” Lilli stated.

Given that the company understands the submission process and the performance requirements represented in the design control documentation, the test protocols are authored accordingly. “Testing is not just a transaction for us. When we perform testing, we connect all the dots from product, design and usability requirements through the testing process to assemble a complete story for the client which helps them be prepared for subsequent audits and reviews,” explains Lilli.

The secret behind EdgeOne’s stellar ability to support clients is its consistent communication throughout the program. When assessing project scope, the company ensures the conversations address the requirements and issues/gaps within a project and then using their wide experience recommend how to achieve successful outcomes and make projects more efficient. During the program, the leadership from EdgeOne oversees the process and stays in touch with the clients to gain constant client feedback and incorporate any changes required. “These interactions extend our service beyond a project or program. We seek to develop a deep relationship with our clients, ensuring that the right people with skill sets are provided for their requirements,” remarks Lilli.

In addition to offering these technical services to clients, EdgeOne places great emphasis on its own culture. Further bolstering EdgeOne’s strength is its strong team of domain experts and seasoned professionals. “We live and breathe our core values; this has been magnified now, especially in the COVID pandemic,” adds Lilli.

Response to COVID-19 and the Future Ahead

During the onset of the pandemic, where most organizations would have flustered to find a balance and take the step forward, EdgeOne’s team effortlessly made adjustments to continue the programs and minimize the impact on the future pipeline of products. With admirable readiness, the company is currently actively engaged with projects to accelerate the development of COVID-19 diagnostic tests, therapeutic innovations, and maintaining support to the existing client programs. EdgeOne offers its support to help these solutions reach the market quicker and make an impact.

Lilli observes that due to COVID-19, market forces are accelerating the development of connected health and digital health products that can be stand-alone devices or integrated into combination product platforms. EdgeOne, already providing its services in the digital health field for existing clients, looks forward to expanding further into that arena. The company has developed unique capabilities and expertise in-house to support digital health platforms from testing as well as design control and submission perspectives.

Having carved a unique niche in the industry based upon Lilli’s vision of the industry’s need, EdgeOne continues to grow and stay ahead of the curve by providing skillsets in various technologies evolving in the market today and keeping pace with it. Moreover, EdgeOne plans to invest in expanded equipment capabilities and advanced technologies to bolster its testing services for combination products and medical devices. “We envision ourselves being a leader of contract development organizations that supports innovative technologies, not just the tried and true ones, but ones that are transformational as well,” concludes Lilli.