From Prototype To Production: How Dexter Helps Optimize Medical Magnets for Ventricular Assist Device Manufacturing
Due to the fast pace and precision of development, medical device manufacturers are specifying biocompatible magnetic materials and medical magnets to be precisely machined in shorter development cycles than ever before. However, the process is rarely free from unique obstacles companies face to navigate to get their products from a prototype to serial production.
Although already a crucial component in many medical devices, the engineering and integration of magnets can get complicated. Dexter Magnetics Technologies has resources that can support these efforts through:
- Ensuring their product meets stringent quality standards
- Maximizing product profitability through intentional management of part cost
- Streamlining production while incorporating unique equipment and processes
- Navigating ISO and FDA requirements
With the help of Dexter Magnetic Technologies, medical device manufacturers can successfully overcome these challenges and see better results with their magnetic materials and precision machined products.
In the following case study, we will look at how Dexter’s approach assisted a company in manufacturing medical magnets for ventricular assist devices.
A Leading Medical Device Company was Facing Challenges Bringing Their Ventricular Assist Device (VAD) Product Design to Life At Scale
A leading VAD company needed support getting its product from the prototype stage to serial production.
The company was looking to:
- Extend the lifespan of the product
- Increase quality to both meet compliance and company standards
- Reduce production costs to increase product profitability
The VAD product needed to meet several essential but tough-to-match requirements which broadly apply to a majority of VAD products:
- Limited stray fields to avoid unnecessary product risk
- FDA compliance and high-quality standards
- Biocompatibility for patient safety
- Durability for product longevity
- Traceability of parts and products
- Serialization and custom packaging of parts and products
- Scalability of production
Dexter’s Approach: A Fully-Integrated Approach to VAD Part Design and Production Optimization
To support the VAD company’s goals and assist them with project development, the Dexter team devised a personalized action plan containing eight key stages:
- As stated by the FDA, the Dexter team worked with the client to navigate their product compliance requirements, providing input throughout all stages of the product design through to serial production. Dexter’s FDA compliance experts gathered all necessary documentation that stated their VAD product was medically-complaint and helped them submit it to the concerned authority.
- The Dexter team helped improve the design with the manufacturability issue in mind. The team created the magnetic couplings to allow the magnet to be magnetized during the assembly process. This process allowed us to enhance manufacturability efficiency significantly.
- Dexter helped the VAD team choose the appropriate coating for the product, which would be hermetically welded and sealed. Dexter’s recommendation for a biocompatible coating material with corrosion resistance helped add an extra layer of protection to the product.
- Each new project must raise the client’s expectations and current work operation. The Dexter team focused significantly on keeping up with the client’s unique high-speed processes considerations. It was able to support their individual needs throughout the collaboration.
- Dexter saw a great need to implement new quality controls to stay compliant. As a result, they could implement standard fixtures and test gauges, allowing easy quality testing.
- Per de FDA requirements, Dexter assisted the client in establishing traceability protocols to track the product through the distribution chain.
- Dexter assisted the client in navigating medical packaging concerns and identifying a vendor who could provide their product with the appropriate solution.
- As part of the trackability protocol, Dexter recommended that our client adopt serialization for their medical device to provide enhanced tracking.
The Client’s Development Outcome
Through Dexter’s approach, our team managed to support our client in overcoming many roadblocks that medical device manufacturers usually face when creating biocompatible magnetic materials and precision machining products.
Improvement to the VAD Development:
- Helped simplify the FDA compliance process, which saves our client tremendous time and resources
- Limited stray field, a prevalent issue with magnetic medical devices
- 15% yield improvement
- 10% cycle time reduction
- Improved speed to market
- Significant decrease in COGS (Cost of Goods Sold)
Thanks to our unique approach and involvement in the magnetic design process, Dexter’s support helped our client generate around $2 million in sales in the first year post-serialization alone.
The Value of Dexter Magnetic Technologies Vertically Integrated Medical Magnetics Experts
As the global leader in the design and fabrication of magnetic products and assemblies, Dexter Magnetic Technologies is a veritable asset for all medical device manufacturers in need of streamlining their operations and successfully launching and scaling a medical magnet-based product.
Apart from manufacturing, our approach includes comprehensive support designed to assist our clients throughout production, taking ideas and converting them into profitable products through award-winning technology such as hermetic sealing and micro-milling.
We encourage you to contact our team for more information about Dexter and our services.