Telos Partners
Offering Robust Regulatory Support to The Evolving Biotech Industry

The significance of clinical studies for promising medication and innovative devices has skyrocketed since 2020 as the world realized the importance of timely and effective treatment methodologies. However, the search and recruitment of physicians as well as clinical research professionals are the primary hurdles that hinder most life science companies from running efficient trials.

Our expertise, coupled with a de-risked methodology and empathetic approach, helps us better understand our clients and their unique challenges

In one instance, a biologics company halted their global study due to physician recruitment challenges. Fortunately, they partnered with Telos Partners, whose seasoned scientific, regulatory, and clinical research professionals converted their gathered data into a real-world study to send pre-submission and De Novo requests to the FDA and boost the project’s value proposition. Telos expertly guided this biologics firm through the FDA process and helped them realize their commercial goals.

This success is attributed to Telos’ tailored methodology which helps medical device and biotechnology companies achieve their objectives without steering away from compliance necessities. It enables companies to tackle challenges driven by the ever-evolving European Union (EU) medical device regulation (MDR) and commercialize their products across the continent. Telos’ portfolio, comprising regulatory, reimbursement, health economics, and scientific expertise, aids clients in meeting the four pillars of successful commercialization: clearance, market access, physician adoption, and distribution.

Telos’ innovative clients serve, primarily, the musculoskeletal (specifically spine, total joints, foot and ankle, trauma, and extremity) and cardiovascular call patterns and it expertly guides them through regulatory processes. Specifically, Telos services include 510(k), De Novo, clinical evaluation reports (CER), premarket approval (PMA), MDR gaps analysis, internal and supplier quality audits, manuscripts, abstracts, KOL management, value dossier (technical files), and evidence publication services. Telos also delivers congress strategies to boost the planning of domestic or global conferences and podium presentations for clinical and commercial personnel, allowing their marketing and sales teams to arrange product content for upcoming presentations.

Along with these competencies, Telos uses an empathetic partnership approach to understand a client’s clinical, regulatory, quality, and commercial challenges. This approach assists them in every step of their compliance journey. It also hosts workshops and round table information sessions to help clients navigate the next potential area of opportunity.

Unlike conventional services that work hourly and often charge thousands of dollars before a work product is delivered, Telos employs a de-risked methodology where clients pay at milestones. These milestones are identified and agreed upon before project kickoff and are clearly articulated in its statement of work.

“Our expertise, coupled with a de-risked methodology and empathetic approach, helps us better understand our clients and their unique challenges,” says Scott Day, VP and General Manager at Telos.

Two things drive Telos’ success, its team culture and diverse experience. Mr. Day and his team have a combined experience in regulatory, quality, medical writing, and commercial operations. It also comprises members from various regulatory bodies, former FDA reviewers, and PhDs that empower effective collaboration and execution. Together, the team regularly hosts meetings at the American Academy of Orthopedic Surgeons (AAOS), North American Spine Society (NASS), and the American College of Foot and Ankle Surgeons (ACFAS), despite its 100 percent remote working model.

Continually spreading awareness of the significance of innovation, Telos has developed and delivered a LinkedIn series, ‘Innovation In Focus,’ which educates clients and followers on innovative implants and solutions and their impact on patients. Moving ahead, it will continue encouraging clients to achieve their business goals and stay updated on new products and innovations in the medical devices and biotechnology industry.