Medical Device Engineering

Do you have a great idea for a medical device and need a partner to realize it and make it ready for market approval? Is your development portfolio bigger than your R&D department’s capacity?

BAAT is your partner in expert medical device design engineering. BAAT has the experience and know-how to transform your dream, idea, technology or problem into a product with manufacturing route, CE/FDA application and operations.

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medical device design engineer showing a medical hip implant

Medical Device Engineering - expertise at your Fingertips

Medical device engineering is applying engineering principles for healthcare purposes. It is not just calculations, drawings and tolerances; it is about creating a meaningful impact on the lives of patients. During the journey from idea to product there are important questions to answer, many of them not of technical nature:

  • What concept works for all users (patient, OR assistant, surgeon, etc.)?
  • How can all users safely and effectively use the medical device? (human factors engineering medical devices)
  • How can the design, production process and packaging be fully specified?
  • Who can work together to make it?
Medical device engineering and path to success graph

More Engineering challenges and asking the right questions

Asking the right questions is the first step to a successful project. Having impact on the end user means impact in the market. Some examples:

  • How can we prove safety and performance for the patient and other users (human factors engineering medical devices)?
  • What strategy and information will lead to market approval?
  • How can we ensure the medical device is fully monitored and traceable from raw material to clinical use?
  • How is the clinical performance of the products tracked and continued access to the market ensured?  This is another example of human factors engineering medical devices.

One of the steps many customers do is answering above questions using an Innovation Scan. We call it ‘Innoscan’. Get in contact with Baat to see what can lead to a commercially viable product development and real impact in the medical device business.

Baat Medical services overview

Innovate

We can maximize your impact

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R & D

We can develop your product

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Operations

We can supply your product

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Legal Manufacturer

We can take responsibility for your
product

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Innovate

We can maximize your impact

How do you know which ideas are successful in the future? And how do you engineer your medical device to be commercially successful? By asking the right questions with our medical engineers, we find out together how to maximize your impact.

R & D

We can develop your product

How to meet technical engineering specifications? And what regulatory pathway should be taken? We know all about design, medical device engineering and validation processes and understand what is needed to pass the notified body and the FDA.

Operations

We can supply your product

How to meet increasing requirements for product delivery? We streamline operations, ensure PMCF traceability and handle post market surveillance.  In this way we minimise Human factors (errors) in engineering medical devices.

Legal Manufacturer

We can take responsibility for your
product

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.

How do you know which ideas are successful in the future? And how do you engineer your medical device to be commercially successful? By asking the right questions with our medical engineers, we find out together how to maximize your impact.

How to meet technical engineering specifications? And what regulatory pathway should be taken? We know all about design, medical device engineering and validation processes and understand what is needed to pass the notified body and the FDA.

How to meet increasing requirements for product delivery? We streamline operations, ensure PMCF traceability and handle post market surveillance.  In this way we minimise Human factors (errors) in engineering medical devices.

How to comply with the ever increasing demands from notified bodies? We take responsibility and can be your legal manufacturer.

Medical Device Engineering Certification ISO 13485 batch

ISO 13485 Certification

Our ISO 13485 quality system (certificates) concerns topics directly related to product development (e.g. verification and validation, risk management, usability), but also addresses many high-level topics such as competence tracking and training, management of standards, control of documents.

When partnering with BAAT, you will not only benefit from the knowledge and experience of our 25+ people with various fields of expertise, our expertise with medical device engineering for both the EU and US markets with 30+ products developed (publication list), but also of our underlying quality system.

It’s all about the quality system to get regulatory approval

Even the best and most experienced medical device design engineers are only as good as the quality system they are working under. At least according to the authorities assessing market approval. That means a team of experts in medical product engineering is not enough; they must use a thorough quality management system to get regulatory approval for a medical device.

Overview image of Quality system medical engineering process

Contact
our expert

medical device design consultancy, new business developer, Dymphy van der Wilk, Baat Medical

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Scientific publications | Get an overview of all research we have done.

Our Customers About Us

Katharina Barsch, Silony Medical, is a customer of Baat Medical
Katharina Barsch
Silony Medical
I appreciate to work together with you and your company. At the end I’m happy with the outcome and I’m looking forward to the market launch. I appreciate the support of you and your company with a lot of experience. Many thanks to you and your team. I would be happy to start a new project in future together with you and I’m looking forward to our cooperation during market phase.
Oliver Hass, Essity, is a Baat Medical customer
Dr. Oliver Hass
BSN Medical | Essity
A great thanks to everyone at Baat medical involved in this project. We are very satisfied with your service (including performance, communication, and flexibility) and are looking forward to possible new collaborations.
Dr Hans Joachim Fischer-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.-Baat Medical Engineering brings medical innovations to market.
Dr. Hans-Joachim Fischer
Waldemar Link
The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.
Photo of a Customer of Baat Medical, Medical Device Innovation Design
Pablo Enriquez
Belfry Medical GmbH
Successful products are not made only of great ideas; they require a good understanding of todays and tomorrows market environment. The INNOVATE process was very insightful. It helped us define and decide what is necessary to fulfil all stakeholders’ present and future requirements in order to have a high impact product and treatment. BAAT did a great job!
Guntmar Eisen, a Baat Medical customer
Guntmar Eisen
EIT, a J&J company
Thanks to the close collaboration of our engineers with the BAAT team, we could execute our development strategy as planned. We couldn’t have reached this level of success without them.
Ariaan-van-Walsum-Baat Medical Engineering brings medical innovations to market. Commercial viability is a leading metric in medical device innovation succes.
Ariaan D.P. van Walsum
Trauma Surgeon, MST Enschede
Baat Medical has made my idea come true. It really contributes to better care for the patient, and to the convenience of surgeons. It's great to work together to realize a medical innovation. I can recommend Baat 100% to surgeons and hospitals that really want to make a move.