---
title: Strategic Partnerships for MedTech Startups
description: Strategic partnerships MedTech startup: when hospital, university and industry deals help, what Article 10 forbids you to delegate, and contract essentials.
authors: Tibor Zechmeister, Felix Lenhard
category: Team Building, Operations & Scaling
primary_keyword: strategic partnerships MedTech startup
canonical_url: https://zechmeister-solutions.com/en/blog/strategic-partnerships-medtech
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Strategic Partnerships for MedTech Startups

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **Strategic partnerships can accelerate a MedTech startup by years. Or sink it. The rule that decides which one you get is simple: under MDR Article 10, the manufacturer obligations stay with you no matter who does the work. Every partnership contract you sign should start from that fact and work backwards.**

**By Tibor Zechmeister and Felix Lenhard.**

## TL;DR
- Strategic partnerships in MedTech fall into three buckets: clinical (hospitals, KOLs), academic (universities, tech transfer), and industrial (CMOs, distributors, OEMs).
- MDR Article 10 places all manufacturer obligations on you. You can outsource tasks, but you cannot outsource accountability. Your Notified Body will audit what your partners do as if you did it yourself.
- The moment a clinical partner collects data on your device under your direction, MDR Articles 62–82 and EN ISO 14155:2020+A11:2024 apply. A loose "research collaboration" is not a legal category. It is either a clinical investigation or it is not, and the consequences are very different.
- Technology transfer agreements from universities routinely contain traps: background IP with narrow field-of-use, publication rights without review, and indemnification clauses that shift regulatory liability onto a 3-person startup.
- Partnerships make sense when they unlock something you cannot build alone. Patient access, a specific technology, a manufacturing line. They are a distraction when they are a substitute for a customer.

## Why this matters (Hook)

Half the MedTech founders Felix has coached came to him with some version of the same question: "A hospital / university / big industry player wants to work with us. Should we say yes?" The honest answer is almost always: it depends, and you probably have not read the contract carefully enough.

The problem is not that partnerships are bad. The problem is that founders sign them for the wrong reasons. They sign because a logo will look good on the investor deck. They sign because a professor wrote a nice email. They sign because an enterprise BD manager promised "pilot opportunities". And then, eighteen months later, they discover that the professor owns the IP, the hospital will not share the data without a new agreement, and the enterprise pilot was a volunteer slot on someone else's innovation roadmap.

The MDR does not care about any of this. It cares about one thing: who is the manufacturer. The manufacturer is fully responsible, full stop. Your partnership strategy has to start from that sentence.

## What MDR actually says (Surface)

**Article 10 (General obligations of manufacturers)** is the single most important article for partnership structure. Article 10(1) states that manufacturers shall ensure that their devices are designed and manufactured in accordance with the requirements of the Regulation. Article 10(2) requires manufacturers to establish a risk management system. Article 10(3) requires clinical evaluation. Article 10(9) requires a QMS covering, among other things, responsibility of the management, resource management, risk management, clinical evaluation, product realisation, monitoring and measurement of output, and corrective and preventive actions.

Crucially, Article 10 makes no allowance for delegation. A manufacturer that outsources production to a contract manufacturer is still the manufacturer. A manufacturer that contracts a university lab to develop an algorithm is still the manufacturer. A manufacturer that partners with a hospital to run a clinical investigation is still the sponsor, unless a different party formally accepts sponsor obligations under Article 2(49).

**EN ISO 13485:2016+A11:2021** operationalises this through supplier control requirements: the manufacturer must qualify, control and monitor any supplier whose work affects product conformity. Your NB will audit your supplier control file whether the supplier is a 300-person CMO or a single postdoc in a university lab.

For clinical partnerships specifically, **Articles 62–82** and **Annex XV** govern clinical investigations. **Article 62** defines the requirements for any investigation of a CE-mark pathway device. **Article 71** sets out sponsor obligations. **Article 72** specifies informed consent requirements. If you are generating clinical data with a hospital partner to feed your CER, you are almost certainly running a clinical investigation under these rules. EN ISO 14155:2020+A11:2024 provides the GCP framework.

There is no MDR concept of an "informal pilot" or a "friendly collaboration" that is exempt from these rules simply because no money changed hands.

## A worked example (Test)

Consider a startup developing a Class IIa wearable for atrial fibrillation detection. They have three partnership opportunities on the table:

**Opportunity A. A university cardiology department** wants to run a 200-patient validation study. The department will draft the protocol, own the data jointly, and publish within 12 months of study closure.

**Opportunity B. A regional hospital group** wants to pilot the device in three sites with 50 patients, "for internal evaluation purposes". No formal protocol, no IRB, no contract. Just a handshake with the chief of cardiology.

**Opportunity C. A large diagnostics company** wants to co-develop the device, share development costs, and take commercial rights in selected markets in exchange.

Here is what each actually looks like once you apply MDR:

**A is a clinical investigation.** The startup is the sponsor. The data will feed the CER. EN ISO 14155 applies. A Clinical Investigation Plan (CIP), ethics committee approval, competent authority notification per Article 70, insurance per Article 69, and informed consent per Article 63 are all mandatory. Joint data ownership is fine if written down; publication after 12 months may conflict with regulatory submission timing. Negotiate a 90-day sponsor review window before any manuscript submission.

**B is a trap.** The "informal pilot" is either a clinical investigation (in which case it is unlawful without the Article 70 procedures) or it is real-world use of a non-CE-marked device (which is unlawful under Article 5). A device without a CE mark cannot be placed on the market or put into service in the Union except under strict conditions. The founder must either formalise B as a proper investigation, restructure it as a feasibility study with clear non-clinical objectives, or walk away. "Friendly" is not a regulatory category.

**C is a manufacturer question.** Who is the manufacturer after the partnership? If the startup remains the manufacturer, Article 10 stays intact and the diagnostics company is a distributor or co-commercialisation partner. If the diagnostics company becomes the manufacturer in its territories, they inherit the Article 10 obligations and need their own technical documentation, QMS and NB certification. A much bigger commitment than most large companies expect. Co-manufacturer arrangements are possible but require very clear allocation of responsibilities in a written quality agreement.

## The Subtract to Ship playbook (Ship)

**1. Ask first: what does this partnership unlock that we cannot build alone?**
Clinical partnerships unlock patient access and KOL credibility. University partnerships unlock specific technologies, grants, and PhD-level expertise. Industrial partnerships unlock manufacturing, distribution, and market access. If a partnership does not unlock one of these, it is probably a distraction disguised as validation.

**2. Always identify the manufacturer in writing.**
Every partnership agreement must say. In plain words. Who the manufacturer is. If it is you, Article 10 stays with you. If it is them, they need to know what they are signing up for. Vagueness here is the single biggest source of disputes.

**3. Quality agreements, not MOUs.**
For any partner whose work affects product conformity. CMO, software development partner, sterilization supplier, test lab. An MOU is not enough. A quality agreement compliant with EN ISO 13485 Section 7.4 is required. It covers change control, non-conformance handling, audit rights, and document retention.

**4. Clinical partner agreements: four things that must be written down.**
(a) Sponsor identification. (b) Data ownership and usage rights, including the right to use data in regulatory submissions. (c) Publication review. Typically 60 to 90 days of sponsor review before submission. (d) Serious adverse event reporting chain that complies with MDR Articles 80 and EN ISO 14155.

**5. University tech transfer: read the background IP clause three times.**
The most expensive mistake is a narrow field-of-use license that lets the university relicense the core IP for adjacent indications two years later to your competitor. Negotiate the field as widely as the science supports. Expect diligence milestones. They are normal, and meetable with realistic planning.

**6. Industrial partnerships: separate the technical from the commercial.**
A co-development agreement is a technical relationship governed by Article 10 and ISO 13485. A distribution agreement is a commercial relationship governed by Article 14 (distributor obligations) and commercial law. Keep them in separate documents. It will save you when you want to change one without renegotiating the other.

**7. Audit rights are non-negotiable.**
Every partner contract that touches product conformity must give you the right to audit the partner at your cost, with reasonable notice. Your Notified Body will require this, and you will need it when something goes wrong.

**8. What you cannot delegate.**
You cannot delegate: the design authority (Article 10(3)), the risk management file ownership (Annex I, GSPR 3), the clinical evaluation conclusions (Article 61), the PMS plan and reports (Articles 83–86), the PRRC role (Article 15), and the EU declaration of conformity. You can subcontract the work of producing any of these. You cannot subcontract the accountability.

## Reality Check

1. For each current partnership, can you name. In one sentence. What it unlocks that you could not achieve alone?
2. Does every partnership agreement explicitly identify the manufacturer?
3. Do you have signed quality agreements (not MOUs) with every supplier whose work affects conformity?
4. For every clinical partner generating data for your CER, do you have a CIP, ethics approval, and competent authority notification where required?
5. Who owns the background IP in your university collaboration, and what happens to it if the collaboration ends?
6. Does your industrial partner understand that a co-manufacturer relationship means they take on manufacturer obligations in their territory?
7. Do you have audit rights in every supplier and partner contract?
8. If a partnership collapsed tomorrow, would your device still be certifiable, or is the partnership a single point of failure?

## Frequently Asked Questions

**Is a letter of intent enough to pitch a partnership to investors?**
For storytelling, yes. For regulatory purposes, no. A letter of intent does not constitute a supplier qualification, a quality agreement, or a clinical investigation agreement. It is a narrative artefact. Treat it as such.

**Can a university be the sponsor of our clinical investigation instead of us?**
Legally possible but rarely advisable. The sponsor owns the data, the reporting obligations, and the liability. If the university is sponsor, they control the CER-relevant data. And they may not share it on your timeline.

**What happens if your CMO has an ISO 13485 certificate already?**
It helps. It does not replace your obligation to qualify them as a supplier, sign a quality agreement, and monitor their performance. Their certificate is input to your qualification, not a substitute for it.

**Is an industrial "co-development partnership" a way to avoid Notified Body costs?**
No. Whoever is the manufacturer of the CE-marked device needs the NB certification. Sharing development cost does not share the regulatory burden unless one party becomes the manufacturer.

**Can you use a hospital pilot as clinical evidence without going through Article 62?**
Only if no clinical data is collected on your device. If patients use the device and any outcome is measured, it is a clinical investigation whether you call it one or not.

**How do you end a partnership that is not working without losing regulatory standing?**
Termination clauses need to cover: transfer or destruction of technical documentation, return of investigational devices, continued data access for regulatory submissions, and continued reporting of any adverse events observed during the collaboration.

## Related reading
- [Outsourced processes and contract manufacturers](/blog/outsourced-processes-contract-manufacturers) – the detailed rules for manufacturing partners under ISO 13485.
- [Working with CMOs under MDR](/blog/working-with-cmos-mdr-startup) – practical playbook for startup-CMO relationships.
- [Supplier qualification under MDR and ISO 13485](/blog/supplier-qualification-mdr-iso-13485) – how to qualify partners whose work affects conformity.
- [The MedTech value chain](/blog/medtech-value-chain) – where partnerships fit in the bigger picture.

## Sources
1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 10 (General obligations of manufacturers), Article 14 (Distributors), Article 15 (PRRC), Articles 62–82 (Clinical investigations), Annex XV.
2. EN ISO 13485:2016+A11:2021. Medical devices. Quality management systems.
3. EN ISO 14155:2020+A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice.

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*This post is part of the [Team Building, Operations & Scaling](https://zechmeister-solutions.com/en/blog/category/team-operations) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*