Orthopedic design development

Do you have an innovative idea for an orthopedic device, or more specifically for an orthopedic implant or surgical instrument, and you need a partner to realize it and make it ready for market approval? Or is your development portfolio larger than your R&D department’s capacity?

BAAT Medical is your partner and expert for orthopedic design, development and manufacturing. BAAT has 25 years of experience and know-how to transform your dream, idea, technology or problem into a product including the manufacturing route, CE/FDA submission and operations when you are in the market.

Design of orthopaedic implants and surgical instruments

Design of orthopedic implants is applying design principles for healthcare purposes, specifically treating issues related to the musculoskeletal system. BAAT Medical is the go-to company for orthopedic design and technology for many customers for over two decades. For us, it is not just about drawings, tests and technologies; 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:

• Which orthopedic concept is applicable for all users; patient, OR assistant, surgeon, etcetera?
• How can all users safely and effectively use the medical device?
• How can the design and the production process including packaging and sterilization be fully validated?
• Who are the partners for production?
• How can we prove safety and performance for the patient
• Which strategy and information will lead to efficient market approval?
• How can we ensure the medical device is fully monitored and traceable from raw material to clinical use when the device is in the market?
• How is the clinical performance of the products tracked and continued access to the market ensured?

When you transform your orthopedic design & technology into a medical device you will encounter hurdles. BAAT is successfully guiding customers to overcome these hurdles since 1999. Use this experience to navigate the intricacies for your orthopedic development and get your device approved for market introduction.

Orthopedic development of implants and surgical instruments
It’s all about the system
Even the best designers of orthopedic implants are only as good as the quality system they are working with. At least according to the authorities assessing market approval. BAAT Medical offers a thorough quality management system to get regulatory approval for a medical device.

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

Experience matters
BAAT has created many orthopedic medical devices for a range of customers since 1999. For us, creating a design for your device is just the start. As your full-service orthopedic development company, we’re partners for the complete journey and are only satisfied when your orthopedic design & technology is successfully treating patients.

BAAT Medical can help you to understand and align the various roles and stakeholders and there needs. And we will generate the required documentation for you.