Successful Outsourcing in MedTech: Working with Partners

Regulatory projects for medical devices are demanding, but the real challenges rarely arise at the technical level or when making major decisions. Much more often, it is expectations, agreements, and minor misunderstandings that can develop into real hurdles during the course of the project.

We wanted to know what makes for good collaboration, so we asked our most experienced project managers. In this article, we share typical pitfalls, best practices, and concrete examples from our projects throughout the entire project phase. We hope this will help us create structures that will also guide you more confidently through your projects.

Phase 1: Commissioning and kick-off

Clarify expectations, define scope

A project is about to start, and the framework seems clear. And yet, this phase makes it particularly clear that what seems "clear" is sometimes only seemingly clear. This is where it is decided whether a project is on solid footing or based on assumptions and unspoken expectations.

If you don't consciously make adjustments at this point, you risk friction, uncertainty, or delays after the first emails or regular meetings.

Typical causes of misunderstandings:

• Assumed knowledge
• Different interpretations of terms and facts
• Unclear responsibilities and obligations to cooperate
• Unspoken expectations regarding methodology, depth, and quality of results

Project case:
A project got off to a rocky start because additional topics were never explicitly excluded. Only a re-briefing with a clear description of the objectives provided the necessary orientation.

"The clearer we are in formulating what we are NOT doing, the better the project runs."
– from our internal survey

Our recommendations for this phase:

• Ensure that you understand all of your project partner's expectations: Make assumptions explicit ("We assume that..."). Don't interpret, ask actively.
• Check the required resources, roles, and time feasibility: Can each side deliver what is needed at the agreed time? Are the review and approval processes clearly defined? Are there substitution agreements in case of vacation or illness?
• Establish rules for how you will deal with changes in scope during the project: If this happens, it will have a decisive influence on the project duration and costs.
• Put agreements in writing.
• Treat each other as equals from the outset: Strive to create genuine cooperation through clear and honest communication. You are now a team for a defined period of time; act accordingly!

Phase 2: Implementation of the project

Perceive nuances, stabilize the project pace

The implementation phase reveals how robust communication really is. Projects rarely stall due to a lack of competence, but rather because of queries that come too late, a lack of coordination, or tacit changes.

Things become particularly sensitive when a milestone is approaching or a submission to notified bodies or authorities is imminent. At this point, at the latest, it becomes clear what has not been sufficiently discussed, documented, or understood beforehand.

"Everything gets hectic before the deadline. In one project, questions arose that showed that basic assumptions had remained different. We have learned to address critical issues in a timely manner and clarify them in a sustainable way."
– from our internal survey

Typical risks:

• Spontaneous changes without joint evaluation
• changing contact persons, delayed feedback
• Unclear priorities in day-to-day business
• Underestimated obligations to cooperate on the part of the customer

Project case:
A project was technically stable but organizationally difficult: changing contact persons, lack of feedback. A moderated discussion and a joint communication plan brought structure back to the project.

"When things get stuck, the only thing that helps is talking: honestly, empathetically, and concretely."
– from our internal survey

Dissatisfaction rarely arises abruptly, but grows when questions are not asked, assumptions are not checked, or irritations are not addressed. The solution lies in early, open communication. Even if you have the impression that "everything is actually going quite well."

Best practices for the project phase:

• Agree on fixed exchange formats: A regular meeting, ideally weekly with a clear agenda, creates reliability. All participants know when topics can be raised. This way, information does not get left behind, but flows back into the project in a structured manner.
• Keep feedback loops short and binding: Make clear agreements about who will respond to what and by when—and stick to them. This prevents idle time and gets the project moving.
• Regularly review the project framework: Goals, timeframes, and priorities can change over the course of a project. Regular reviews prevent people from working at cross-purposes. A simple "Are we still on track?" often works wonders.
• Address difficulties before they become entrenched: Problems that are not addressed will grow. Addressing irritations early on prevents conflicts later on. Open communication is not unpleasant; it is professional.
• Document relevant decisions in a comprehensible manner: Important agreements, role changes, or schedule changes should be recorded in writing, comprehensible and retrievable for all parties involved.
• Think together from the goal: What does the manufacturer need to further process the result? What does the service provider need to deliver documents efficiently and in compliance with regulations? Those who practice this change of perspective regularly prevent conflicts of interest and create real project benefits.

Phase 3: Completion and evaluation

Reflection creates trust

Once the service has been provided, the project conclusion determines how the collaboration will be remembered. Is the invoice simply sent? Or do both sides take the time to review the project?

A successful conclusion achieves three things:

• Reflection: What went well? What needs improvement?
• Appreciation: Consciously highlight successes.
• Thinking ahead: Are there further needs or follow-up projects?

Project case:
A project was concluded with a joint review. The manufacturer provided open feedback—both positive and constructive. Shortly thereafter, another project followed, whose kick-off was significantly more efficient thanks to the previous reflection.

"When a customer comes back, it shows that we have built trust and delivered real added value."
– from our internal survey

Regulation meets reality

Why good cooperation is also a compliance factor

ISO 13485:2016 (Section 4.1.5) and 21 CFR § 820.50(b) require written agreements for outsourced, quality-related processes, in particular for defining product-specific requirements. A quality assurance agreement (QSA) is therefore not only a regulatory requirement, but also an effective means of clarifying goals, expectations, and responsibilities at an early stage, thereby laying the foundation for reliable collaboration between the respective stakeholders.

Conclusion: Good cooperation can be shaped

Good cooperation is not a coincidence; it can be shaped. Clarifying expectations at an early stage and consciously managing communication promotes mutual understanding, strengthens trust in each other, and increases the quality of results. And that is precisely the basis for regulatory resilience.

Or as a colleague aptly put it:

"Not every collaboration works right away, but every project can succeed if both sides really want it to."

If you want to further refine your own structures:
Our First Aid Kit for Manufacturers contains practical materials, checklists, and templates to help you set up projects on a stable footing and implement them in a regulatory-compliant manner.

And if you have specific questions about collaboration, roles, or regulatory processes,

Please contact us.  We are happy to assist you.