The experts at Holland Innovative are regularly asked for support in medical product development. When supporting organizations, they make grateful use of their pragmatic approach and knowledge of the application of current legislation and regulations.

‘Successful product development within medical requires a wide range of knowledge and expertise in areas such as Project Management, Reliability Engineering, Data Science and Six Sigma. We apply such project and product expertise to support and help innovative companies develop medical devices that are safe. As well as making sure that such devices are in line with their intended use and comply fully with applicable laws and regulations,’ says Lisette van Steinvoren, Competence Lead MedTech at Holland Innovative.

Lisette van Steinvoren, Competence Lead MedTech at Holland Innovative

‘What we often see is that companies only pay attention to building up the necessary technical documentation for product release at a late stage in the development process. With all the possible adverse consequences this entails,’ continues Lisette van Steinvoren.

‘The MedTech team at Holland Innovative, therefore, specialize in supporting our clients in successfully setting up this type of project, so that the correct development process is followed from the earliest possible stage in the development process’.

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Helping to develop safe medical devices product

‘It’s great that customers turn to us as experts in the field of medical product development. It’s even better if we can provide customers with the tools to get going themselves,’ says Jolande Koobs, Senior Project Manager Medical Devices at Holland Innovative.

‘At Holland Innovative I mainly focus on coaching and supporting companies in the development and certification of medical devices. With the goal of safe products that do what they promise. These companies often have fantastic, innovative ideas developed by enthusiastic people, who want to contribute to a better world with the final product. But in order to bring to market good and safe products, it is necessary to plan certain activities in a timely manner during the design and production process. For example, carrying out a risk analysis, writing a plan for testing the product, or a user analysis to determine the critical parameters for the product.’

Jolande Koobs, Senior Project Manager Medical Devices at Holland Innovative.

Lisette van Steinvoren: ‘We work mainly for international companies, collaborating on specific development issues, or quality and regulatory issues. This includes the consequences of the MDR transition. In navigating this transition we, first of all, help companies identify which aspects of the process will be subject to change. The next step is to guide them in successfully implementing these changes. We do this using a project-based approach, which has time-and-again proven its effectiveness in our many years working as project management experts.’

‘Characteristic of our approach is our pragmatic style. We look at what fits in well with a certain company’s way of working and how processes can be organized in such a way that they really benefit product development, instead of being a paperwork tiger. When it comes to product development issues, we can take the lead as a project manager, but we can also provide support in drawing up technical documentation. Or we can use our statistical know-how and experience for verification and validation analyses, risk management or production optimization. We do so with a maximum of flexibility. Depending on what is required, we offer support by means of coaching, filling in a specific project component or fulfilling an interim role within the organization.’

‘The fact that the MedTech team within Holland Innovative includes specialists with a solid technical or biomedical background in various areas – Project Management, Design for Six Sigma, Law and Regulations, Quality Management, Reliability Engineering & Data Science – means that we can make the right match with our customers.’

Jolande Koobs

CE tool – ensuring devices meet all certification requirements

‘We also want to make this knowledge and experience accessible to startups. For instance, to help them determine at an early stage of product development whether their product should comply with medical legislation. To this end we recently introduced the CE tool. Companies -both small and large – can now use this quick scan to quickly and easily determine whether they need to comply with medical device requirements when developing or manufacturing their product or software,’ Lisette van Steinvoren explains.

‘Particularly with startups, we see that they start developing before they know which legal requirements the product has to meet. And once they do get down to working on certification, they don’t do it in the right order. Then it is difficult to go back. The CE tool is a perfect starting point for such smaller companies that often have a limited budget.’

Jolande Koobs: ‘By using the tool at the beginning of a development process, you can immediately determine which risk class a medical device falls into. This makes it possible to draw up a fail-safe step-by-step plan right through to certification. The good news is that the CE tool will also be available in English next year!’

Courses & projects

Lisette van Steinvoren: ‘The MedTech courses offered by Holland Innovative are a good reflection of our conviction that a pragmatic and broad approach offers the best results. What’s more, we immediately link what has been learned during the course with on-the-job coaching or in combination with a project.

Eager to learn more about MedTech at Holland Innovative or looking for a job?

If you’re excited by the idea of supporting customers in designing and producing medical devices, check out our vacancies. We are currently looking for a QR&RA Specialist and a Project Manager MedTech.

For more information about MedTech at Holland Innovative or about this article please contact Lisette van Steinvoren

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