MedTech Legal Advisory: Contracts, Distribution and Market Entry
Selling a medical device is rarely a simple sale. There is a distributor in one country, a clinic evaluating the system in another, an importer of record, a service obligation and a regulatory file that every contract has to respect.
I have worked on these questions from inside a medical device company and as its external counsel. I support MedTech companies on the commercial side of their business, from the first distributor conversation to disputes over who pays for what.
What I help with
- Distribution and reseller agreements, including exclusivity, territories, minimum purchase and termination
- White label and private label (OEM) agreements, where one company manufactures the device and another sells it under its own name, including who acts as the legal manufacturer under the MDR, quality agreements, IP and product liability
- Placement, loan, demo and evaluation agreements with hospitals and clinics
- Supply, service and maintenance agreements
- Importer of Record and logistics arrangements for the US and other markets
- Delivery terms, customs and cost allocation under Incoterms
- NDAs, cooperation and research agreements with partners and clinical sites
- Data protection in commercial practice, such as consent forms and marketing materials
- Protecting know-how and IP in partner relationships, including cease-and-desist letters
MedTech startups: founding, funding and growth
Many MedTech companies start as startups or spin-offs, and need investors long before their first sale. I support founders and companies from the founding documents through every funding round, so that the structure works for investors and still protects the people who built the product.
- Founding documents and articles of association for MedTech startups and spin-offs
- Seed and growth rounds: term sheets, investment agreements and investor rights
- Founder vesting and ESOP to attract and keep key people
- Spin-off structuring, including IP and licensing between the parent and the new company
Where my work fits
I handle the commercial and contractual side. I do not replace your regulatory affairs team or a notified body. I make sure your contracts reflect the regulatory roles you have already defined, such as manufacturer, importer and distributor, and that risk and cost sit with the right party.
How we can work together
- Ongoing external counsel for companies without an in-house legal team
- Project-based support for a single agreement, negotiation or market entry
- A second opinion on a contract before you sign