Introducing: Faros MedWorks

Your Integrated Innovation Partners in MedTech.

Faros MedWorks is a TheraNova spin-out providing external start-ups bespoke support from across the full MedTech lifecycle. We uncover critical gaps early, apply veteran expertise, and work side-by-side with your team to accelerate your growth.

We customize the process to align with your unique goals, providing support in as many—or as few—areas as you require.

Download our Brochure

Our Programs

Stage-1: Evaluation

  • We assess the strength of your scientific foundation and quality system (“QMS”) that supports your pre-clinical data. We develop a strategic plan to bolster and validate your innovation.

  • We help transform technical breakthroughs into commercial products by validating market need, analyzing the competitive landscape, and attaining product market fit.

  • We analyze the strength of your patents as “blocking IP” and your freedom-to-operate. Then, we collaborate with you to optimize your strategy, including but not limited to, filing a portfolio of provisional patents.

  • We determine your product’s regulatory classification (e.g., Classification, Predicates) and guide you through the optimal pathway (i.e., QSub, STEP, Breakthrough, etc.

  • A strong reimbursement strategy ensures your product is accessible and financially viable. We help you understand the potential reimbursement (e.g. CPT, HKPCS, DME) and develop a plan to maximize coverage.

  • We help you become investor-ready and lead you through the funding process. We will introduce you to capital, whether non-dilutive grants (NIH, NSF, CDMRP) or dilutive (venture/CVC) starting from a solid deck.

Stage-2: Commercialization

  • We offer in-house design, development, and manufacturing support comprising software, electro-mechanical, industrial design, QA, and certification.

  • This program moves beyond product market fit. We work with you to design and execute a full product launch campaign.

  • We develop a comprehensive patent strategy based on your business needs and draft the appropriate patent applications.

  • As your CRO, we manage, coordinate, and execute your clinical trials. We work with you through full regulatory processes (i.e., FDA’s 510(k), De Novo, or PMA; CLIA LDT, CDSS, MDDT, Wellness, etc.).

  • We qualify your device through the appropriate reimbursement code (i.e., CPT, HCPCS, DME) and, if needed, help you qualify for a new code.

  • We will provide hands-on fundraising assistance, including: warm introductions, attending pitches, and term sheet negotiations.

Faros MedWorks offers two flagship programs for startups: Evaluation and Commercialization. The aim is for participants to progress through the evaluation program and graduate into the commercialization program.

Program Leadership

Dan Burnett

Dr. Burnett received his M.D. from Duke University and concurrently obtained an M.B.A. from Duke’s Fuqua School of Business. Since 2006, Dr. Burnett has raised, or helped raise, over $400M for the TheraNova spinoffs. He is an inventor on ~60 issued patents. He is also an adjunct faculty member in the Bioengineering Department, and joined University of California San Francisco as an entrepreneur-in-residence with QB3.

CEO

Eran Steinberg

Eran holds M.Sc. degrees in Imaging and Regulatory Science from RIT and Johns Hopkins. He is a serial founder/CEO with five successful exits, an inventor on ~300 issued patents, and an active investor and board member in early-stage companies. As a licensed USPTO patent agent, he brings deep expertise in regulatory and IP strategy. He is also an adjunct lecturer in Johns Hopkins’ Biotech Entrepreneurship Graduate Program and at the Tel Aviv School of Medicine.

CSO
Program Manager

Steph Jump

Steph received her MSc/MA in Innovation Design Engineering from Imperial College London and the Royal College of Art, as well as dual bachelor’s in Biomedical Engineering and Physics from Dartmouth and Vassar Colleges. Her career has spanned biotherapeutics research, healthcare business strategy, and early-stage product development. She has won multiple awards, including scholarships from the Royal Commission for 1851 and the Pokémon Company.

Learn more by downloading our brochure.

If you're interested in working with us, email steph@Faros.Med.