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Solutions · Medical device launch

The parts of a device launch that are not the device

The Virtual C-Suite gives a medical device company the three executives it usually cannot afford before revenue: a registered patent attorney as general counsel for intellectual property, contracts and regulatory-adjacent legal work; a CIO for the data, software and cybersecurity obligations that now travel with a device; and a chief security officer for facilities, supply chain and people. We are not a regulatory affairs consultancy, and we work alongside yours.

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What usually goes wrong

  1. The invention is disclosed (a conference talk, a pitch deck, a supplier call) before a patent application is filed, and the filing options narrow
  2. The contract manufacturer, the software contractor or the clinical partner owns a piece of the intellectual property because nobody wrote the assignment clause
  3. The device collects data, and the company finds out at submission time that FDA expects cybersecurity documentation for devices with software, and that HIPAA and state privacy law may reach the data the device creates
  4. Electronic records and signatures in the quality system are set up in a way the auditor will not accept
  5. The founder's laptop is the quality system, the design history file and the cap table

What we do in the first 90 days

  1. Days 1 to 14David reviews every agreement (founders, contractors, suppliers, advisors, clinical sites) for IP assignment, confidentiality and change of control; Duane inventories the systems that hold design, quality and clinical data and the device's own software and data flows; Daniel walks the facility and the supply chain.
  2. Day 15One findings list, ranked by what blocks a submission or a financing.
  3. Days 15 to 90Patent and trademark strategy and filings; IP assignment and contract fixes; a data and cybersecurity plan for the device and the company that your regulatory consultant can cite; facility and supply chain security standards.
  4. Day 90A written review and the standing retainer decision.

Which seats

General counsel (patent attorney) and CIO on every engagement; chief security officer when there is a facility, a supply chain or a clinical site to protect.

Who it is for

Pre-revenue and early-revenue device companies in the DMV with a founding team, a regulatory consultant and no in-house counsel, CIO or security lead. Companies with a connected or software-driven device. Companies preparing for a financing where the IP and the data story will be diligenced.

Who it is not for

Companies looking for regulatory affairs, quality system consulting or a submission writer; we work with those firms and can refer them. Companies that need a CTO to build the device software.

Why us for this

David is a registered patent attorney who has been the founder whose company depended on its IP. Duane has run security and data programs for regulated clients for a decade through EDG.tech. Daniel has assessed facilities for organizations where a security failure is a headline.

The three seats

David Moore
David MooreVirtual General CounselRegistered patent attorney. Founded, built and sold a technology company before law school.Fractional general counsel →
Duane Epperly
Duane EpperlyVirtual CIO30 years in IT. Founder of EDG.tech and co-owner of two franchise businesses.Fractional CIO →
Daniel Ramos
Daniel RamosVirtual Chief Security Officer25 years in the FBI, retired as Assistant Special Agent in Charge.Fractional CSO →

Questions owners ask

Can you file our patents?

Yes. David is registered to practice before the USPTO. Patent prosecution is quoted per matter alongside the retainer.

Do you replace our regulatory consultant?

No. We handle the legal, technology and security work that sits next to the submission, and we coordinate with your regulatory consultant.

Does FDA care about cybersecurity for our device?

For devices with software or connectivity, FDA expects cybersecurity information in premarket submissions. Your regulatory consultant will tell you what your device needs; Duane makes sure the company can produce it.

What does this cost?

The retainer ranges are on the pricing page. Patent and trademark filings and government fees are extra, quoted before they start.

Tell us the decision you are stuck on.
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