Outsourcing the design and development of medical devices can be a smart move — but it's not without its challenges. This blog post looks at when and why outsourcing design and development (D&D) makes sense, what the risks are, and how working with a single, end-to-end development partner can help avoid some of the most common pitfalls on an OEM's path to market.
Why medical device companies choose to outsource D&D
As companies design cutting-edge new devices, they must ensure they can build what they specify in the most efficient and cost-effective way possible. They also need to be confident they can sell their end products into the markets where they’ll see the most commercial success.
Given the uncertainty of supply chains and shifting trading landscapes right now, it’s no wonder more and more OEMs are looking for value engineering, design AND manufacturing support to help de-risk their road to launch.
6 triggers for outsourcing your medical device D&D process
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Development is stalling because internal teams can’t keep up with project timelines or regulatory complexity.
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You need access to specialist expertise in electronics, embedded systems, industrial design, or regulatory knowledge that you don’t have in-house.
- You need support with iterative prototyping to take you through each stage of development
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You’re entering new markets with different compliance requirements and want help navigating them
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You want to grow your product range but don’t have the internal capacity or capital investment to do so.
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Trading eco-systems are changing fast. You need to ensure your designs can be built effectively and delivered in the markets where they can make the biggest impact.
Each of these pressures can turn outsourcing D&D from a tactical decision into a strategic one.
We chose ESCATEC because they could provide us with a complete solution from designing how the product would work right through to the final production process, all conforming to the ISO standard for medical equipment – ISO13485. Our product is an extremely complex device that people’s lives depend on, so it is vital that it is designed and built to the highest standards.
Peter Rossegger, Former CEO of Carl Reiner GMBH
The disadvantages of outsourcing design and development
Some OEMs decide to outsource design, prototyping, regulatory review, and manufacturing across separate vendors. While this approach can be flexible and cost-effective, it often introduces hidden risks and inefficiencies:
1. Creating designs without manufacturing or regulatory input
A design may look good on paper but face delays around establishing feasibility and validation as development continues.
2. Prototyping doesn't always mirror production realities
When prototypes are developed outside the context of full-scale manufacturing, they may overlook key factors like production tolerances, material availability, or assembly constraints. While specialist prototyping companies excel at speed and iteration, they may not always apply the same Design for Manufacturability (DfM) rigour as a production-focused manufacturer
3. Communication can break down between dispersed partners
Communication gaps and weak change control processes across separate agencies can increase the likelihood of errors emerging in documentation, as well as slow issue resolution.
4. Responsibilities can become blurred.
Using multiple partners can make it harder to hold any one vendor accountable for setbacks and remove obstacles to project completion.
5. Late-stage surprises can emerge
Issues such as unscalable components, usability failures, or regulatory non-compliance can derail commercialisation, just at the stage when you should be embarking on full-scale production.
These challenges are magnified when outsourcing partners lack a shared understanding of the product vision or when OEMs have to act as the bridge between disconnected vendors.
The advantages of outsourcing design and development
On the other hand, working with a single partner who can handle everything from early proof of concept through to production brings a number of advantages — especially for complex or highly regulated medical devices:
1. Better continuity, fewer delays
When one team is responsible for supporting every stage of design and development, there’s less room for miscommunication or missed handovers. Everyone’s working from the same set of priorities, and changes are easier to manage.
2. Access to specific skills
If you haven't got the expertise in house to get your designs over the line, accessing a larger, global repository of third party expertise is a smart idea.
When a leading Silicon Valley pharma company faced challenges miniaturising and refining their next-gen inhaler, they turned to ESCATEC for expert support. ESCATEC's team in Switzerland helped transform a bulky prototype into a compact, user-friendly device with precise temperature control, embedded software, and a streamlined design ready for clinical trials - delivering the technical expertise and manufacturing insight the in-house team lacked.
ESCATEC didn’t just solve our technical challenges—they helped us rethink the entire device architecture, making it easier to use and manufacture.
Senior Engineer, Silicon Valley Pharma Company & ESCATEC Customer
3. Iterative prototyping
Medical devices rarely go from concept to finished product in one step. You need multiple prototypes, tweaks to the design, and input from clinicians and users.
A single team can handle this back and forth faster — because they’re already looped into every part of the process.
Improving clinical performance was one challenge, but ensuring the device remained easy to use was just as crucial. ESCATEC refined every detail to enhance the patient experience.
Senior Engineer, Silicon Valley Pharma Company & ESCATEC Customer
4. Stronger focus on manufacturability
If the design team is working alongside the manufacturing engineers, they’ll be building with real-world constraints in mind. That avoids costly redesigns later when you’re trying to scale up.
5. Access to global facilities
When your partner has manufacturing sites around the world, you get flexibility built in. You can assemble products close to your end markets, meet local regulation, and respond faster to changes in demand more effectively.
6. Resilience in a changing trade landscape
New tariffs and trade tensions are forcing OEMs to rethink early on about where and how they will manufacture. As you design and develop new products, you need peace of mind that you're specifying raw materials and components that you can access easily and at the right price. Working with a single partner, with flexible supply chains and global manufacturing capabilities, will help you design and manufacture devices in ways that navigate these challenges.
6. Cost control
The risk of spiralling costs can be contained through the outsourcing process. With one integrated team making smart decisions from the outset — from materials to manufacturing methods — you can avoid costly late-stage changes and keep your budget on track. Add to that their buying power, global supplier networks, and a deep focus on efficiency, and you get a development process that’s engineered to drive value.
The risks you still need to manage
But, outsourcing isn’t a silver bullet. It still requires the right partner and the right processes. Some common concerns include:
- Worries about loss of control — especially over intellectual property or key design decisions.
- The challenge of managing a relationship across time zones or cultures.
- The risk of getting locked into a partner who won't meet your long-term needs.
These risks are real - but they can be managed through clear contracts, strong communication, and by choosing a partner dedicated to transparency and collaboration.
Working with a supply partner with deep sourcing expertise, regional manufacturing options, and strong supplier relationships is essential. These partners can help you navigate uncertainty by identifying alternative sources for raw materials, qualifying equivalent components, and maintaining continuity of supply even in volatile conditions.
But you need to be sure that your partner will work with you effectively and that, regardless of the size and global scope of their operations you'll get the 1-2-1 attention you need.
Arrange site visits and/or virtual tours of facilities to assess the size and readiness of their operations both locally and overseas. Going forward, you should expect complete visibility and hands-on support throughout your NPI process. You should expect face-to-face quarterly and annual business reviews once the product is in the market, as well as regular global supply chain and business updates from a dedicated accounts team throughout the product lifecycle.
Asmin Perviz, D&D Manager at ESCATEC
For more insight, read our top tips for choosing a medical device outsourcing partner.
When outsourcing makes sense
The pressure is on. The demand for life-saving medical devices for an ageing population is rising. Devices are becoming more complex due to miniaturisation and implantable technology. But regulations are tightening and changing, with the USA's FDA facing delays and potential shifts in direction.
Right now (in May 2025) the USA's FDA regime seems in confusion, as cuts are elongating device approval times and new leadership signals a change in direction. Trump’s instincts for deregulation may clash with RFK’s concerns regarding the quality practices of med tech companies - causing all kinds of unpredictable changes to the FDA’s role.
At the same time, international supply chains are slowing up access to raw materials and components as trade wars increase friction.
Given this context, everyone involved in your outsourcing process should be dedicated to helping you navigate changing technical and commercial challenges in the best possible way.
Conclusion: keeping it simple, keeping it connected
Medical device development is never easy. But it becomes even harder when responsibilities are spread too thin across disconnected partners.
Outsourcing can help - but only when it’s structured to reduce complexity, not add to it. That’s why working with a single, end-to-end development and manufacturing partner can be such a smart move. It gives you more control, better visibility, and fewer surprises — especially when timelines are tight and the market is moving fast.
In a world where global trade is in a state of flux, having a partner who can offer flexibility, local manufacturing, and proven compliance credentials isn’t just nice to have. It’s essential.
To see how this kind of partnership works in practice, read our guide to outsourcing medical device development and explore our library of med-tech case studies.
