Medical device development

Bright ideas flourish through the help of an expert. So let’s say you have an innovative idea for a new medical device or an update of an existing one. It might seem like a challenge to turn it into reality. You could be missing key knowledge, facilities, or staff. It might be unclear how best to incorporate essential functionalities. Or you may need out-of-the-box thinking to help you make a technology leap. Our medical device development service gives your project all the support it needs. From expert and multidisciplinary advice to technical support and more.

Your benefit out of medical device product development

When developing a medical device product, you face different challenges. Cutting-edge technology and strict regulations often add an extra level of complexity and can impact the medical device development process. To select – and stay on – the route that leads to success, answering these interconnected questions helps:

  • How can I get the most out of new technology while de-risking its use in medical device development?
  • Is my medical device design feasible, and does it include – clearly and precisely – exactly the specifications it will need in all of its future development steps?
  • What alternative solutions can help me maximize reliability, minimize costs and still ensure regulatory compliance in my medical device development?

With expert guidance and top-notch support, you can overcome any obstacle during the medical device development process. Our team of medical device developers at Philips Engineering Solutions provides you with the insight, infrastructure, and hands-on help you need, in whichever medical device development phase you’re in. You get all the tools you need to access these resources at any stage of medical device product development – from conceptualization to engineering & design and even small-series production. At each one, our team helps you make clear definitions and smart choices that protect you from costly mistakes, ensure the desired quality and increase your speed to market.

Customer case

Gilbert Technologies and Philips Engineering Solutions team up on medical device development

There may be new hope on the horizon for lung patients with difficult-to-treat conditions, like fibrotic diseases and severe asthma, thanks to Dutch start-up Gilbert Technologies.

Together with Philips Engineering Solutions, the company and its medical engineering technologies are working to turn its proprietary soft mist technology into a first-of-a-kind medical inhaler device, which has the potential to improve treatment effectiveness for patients and reduce medical costs.

Read more ›

What you can expect of our medical device development support

We provide you with all the support you need for your project to reach the next technology readiness level. In each of the following medical device product development areas, we can deliver our services and also act as a dedicated project partner.

1. Requirement definition & architectural design

Our system architects capture all input required to create a well-defined medical device design. One that ensures reliable performance and regulatory compliance. All key angles are covered: from functional and interface requirements to safety standards. We also cover a host of other factors such as tolerance, cost & manufacturability, risk management, inspection, and traceability. Based on gathered input, experts create the necessary documentation to guide engineering team(s) through the concept, development, realization, and verification phases.

2. Product prototyping & initial testing

Our medical device prototyping and testing services can be valuable in confirming an idea’s feasibility or appeal. During this process, we also compare different concept functionalities and eliminate costly mistakes early on. A tangible prototype or functional model helps teams develop a common understanding that leads to more focused cooperation – and better medical device development. We can even put our dedicated professional workshops and manufacturing methods expertise to work to develop custom manufacturing processes for your needs.

3. Engineering & design

Design is not just about tailoring a products’ ‘look and feel’ to reflect your brand. It’s also about deciding how to incorporate key functions in a constrained environment. Our engineers work easily in the virtual world to transform completely new medical device or sub-system concepts into proven design principles. CAD is our standard environment, but skilled hand-sketches are also often very useful in evaluating medical device development. Making full use of our Quality by design tools and methodologies, we help your team make important choices early on that generate great advantages later in the development chain.

4. Realization

At a certain stage in the medical device development process, designs need to be transformed into testable assemblies. Philips Engineering Solutions can provide support in component acquisition, supply planning, and follow-up to meet the most challenging timelines. If necessary, we can extend our internal manufacturing capabilities with external partner capacity to ensure cost, quality, and schedule targets are met.

5. Integration

When all required parts are available, we offer experienced technicians who can assemble them into the required sub- or system assemblies. The medical product development experts will compile test plans to qualify the functionality of components and interfaces to guarantee speed and quality during commissioning.

6. Verification

We provide thorough medical test & verification services that enable you to prove your medical device design meets the safety standards that regulatory bodies, such as the FDA, CSA, CE, and UL, recognize.

7. Small series production

We often have customers who require a small number of devices to do product validation with end-users. Our in-house, small-series production facilities make it possible to deliver these, saving you the investment of having to tool-up an entire production facility.

8. Micro Devices (The Greehouse)

You have a high-tech, complex idea or concept which requires a custom microsystem solution and you are looking for technical verification and validation. Can it be made? Reliably? How best to decide between conflicting Micro Devices requirements? You want to make the best decision because about 80% of your key product properties like manufacturability, cost price and reliability are defined in the development phase.

The process of medical product development

Whether you are new in venturing and eager to take your idea to the next stage, or already have experience and want to accelerate your project: during the medical device development process, the right and custom-made support is key. During all of the different medical device development phases. So you can fully focus on building the first product, start sales, and scale the business. The faster, the better.

At Philips Engineering Solutions we have the experts and experience in designing, developing, and delivering innovations for start-up ventures, but also offer the quickest route to the best available experts and flexible resources for scale-ups. Our venture proposition to support medical device development from prototype to regulatory approval is as follows:

E2E | Design, develop, deliver your innovation

Based on the phase that your venture is in, we can support you with complementary expertise in business design, technology, and supply. All along your journey to the market.

Our team, which consists of 1,000 experts in the field of the medical device product development process, can cater to your specific needs. Whether you require high-precision engineering, industry consulting, designs for reliability solutions, business case creation, risk analysis, or solving scalability challenges. With the support of Philips Innovation Services, you can accelerate any bright idea or innovation.

Our approach for medical device development

We’re happy to help. Philips Engineering Solutions has decades of experience in every stage of the medical device product development process. What’s more, our medical device development expertise crosses the entire ‘care continuum’ and offers a holistic insight and approach. From devices that facilitate healthy living, to those that enable prevention, diagnosis, treatment, recovery, and homecare. Our expertise and way of working have led to great solutions in the fields of health monitoring, connected personal health, hand-held diagnostics, patient recovery systems, and smart drug delivery. Whatever your focus area, our engineers and other experts can work with you as individual specialists or in multidisciplinary teams – and meet all your needs and wishes.

What our partners value

“Ruggedisation of the Multi-Modality Touch Screen Module for the Core M3 project is very well managed by the project manager from Philips Engineering Solutions, keeping various stakeholders informed on technical developments and financials. This is a great example of collaboration and how projects should be managed.”


Pritam Bhosale
Director R&D Console, IGT Devices

When commencing a medical innovation, your focus is on finding your way to the market. But how to tackle technological challenges and prove the medical claim, whilst your project planning is stretching and medical regulations are non-negotiable?

Contact us about medical device development

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