Do you have great ideas for medical product design 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 product design and development. BAAT has the experience and know-how to transform your idea into a medical device with manufacturing route, CE/FDA application and operations.
Medical Product Design and Development
Medical device product design is applying design principles for healthcare purposes. BAAT has been the go-to company for medical product design and development for many customers for over two decades. For us, it is not just about design sketches, calculations and tests; it is about creating a meaningful impact on the lives of patients.
“Making your product a success is my biggest goal!”DymphyBusiness Developer | Baat Medical
During the journey from idea to completed biomedical product design there are important questions to answer:
- What concept design works for all users (patient, OR assistant, surgeon, etc.)?
- How can all users safely and effectively use the designed medical product?
- How can the design, production process and packaging be fully specified?
- Who can work together to make it?
When you transform your idea into an approved medical device product design you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies for your medical product design and development and get your product approved for market introduction.
- How can we prove safety and performance of the medical product design for the patient and other users?
- What strategy and information will lead to market approval?
- How can we ensure the medical product is fully monitored and traceable from raw material to clinical use?
- How is the clinical performance of the medical products tracked and continued access to the market ensured?
Medical product design: it’s all about the system
Even the best medical product designers are only as good as the quality system they are working under. At least according to the authorities assessing market approval. That means an expert design team is not enough; they must use a thorough quality management system to get regulatory approval for a medical product.
Certified ISO 13485
Our ISO 13485 quality system (certificates) concerns topics directly related to medical product design and 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+ team of experts of various fields, but also our underlying quality system.
BAAT has created many biomedical product designs for a range of customers since 1999. For us, creating the design is just the start. As your full-service medical product development company, we’re partners for the complete journey and are only satisfied when your medical product is successfully treating patients.
Contact us to reach your goals
Use our expertise in medical product design to reach your goals while maintaining flexibility. Contact us today to use our solid foundations of expertise, experience and our thorough ISO 13485 quality management system.
Our Customers About Us
“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!”Pablo EnriquezBelfry Medical GmbH
“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.”Guntmar EisenEIT, a J&J company
“Baat heeft gezorgd dat mijn idee werkelijkheid is geworden. Het draagt nu echt bij aan betere zorg voor de patient, en aan het gemak van chirurgen. Geweldig om samen te werken aan het realiseren van een innovatie. Ik kan Baat 100% aanbevelen aan chirurgen en ziekenhuizen die echt stappen willen maken.”Ariaan D.P. van WalsumTrauma Chirurg, MST Enschede
“The engineering services of Baat really complements our own design process, while seamlessly integrating into our existing operations.”Dr. Hans-Joachim FischerWaldemar Link
“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. Oliver HassBSN Medical
“I would be happy to start another project in future and I’m looking forward to our further cooperation.”Katharina BarschSilony Medical