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Medical Magnets: Magnetic Medical Device Manufacturing Mistakes and How to Avoid Them

mardi 30 août 2022

Medical magnets and manufacturing medical devices require expert consideration of the selection of the appropriate grade of magnetic material, method of biocompatible encapsulation, and manufacturing processes that include high-quality, precision machining. However, as medical device manufacturers work to integrate magnetics and precision machining considerations into bringing their medical device vision to life, technology and engineering leaders may encounter technical challenges. 

The unique properties of magnetic materials are among the reasons why they are widely used in the manufacture of and the final designs of medical devices. Magnets are crucial in manufacturing MRI machines that help diagnose medical conditions and diseases. They are  used in hearing implants, sleep apnea devices and ventricular assist devices. Additionally, magnets are handy in prosthetics and help improve the quality of life for patients with physical limitations.

While magnets serve essential functions in many medical applications, several things can go wrong, or impact final performance, if not guided by magnetics expertise. However, most engineering teams may not have expert knowledge on integrating magnets into medical device designs, components, or manufacturing processes. This often results in production hiccups arising from marginal part design and lower product performance and potentially, product longevity.

Dexter Magnetic Technologies specializes in the challenging aspects of this process, enabling medical device engineering teams to move products more quickly from prototype to serial production while maintaining high quality, maximizing cost, and maintaining ISO and FDA, and MDR  compliant processes. 


Common Mistakes Engineers Make When Manufacturing a Magnetic Medical Device 

While using magnets opens many opportunities to medical device engineers, incorporating magnets into medical parts requires utmost care. The engineering must keep in mind a high level of safety for patients, nurses, and doctors. And, the team must simultaneously balance production efficiency and processes with part quality. Some of the most common challenges that affect most manufacturers during the engineering process include:

  1. Corrosion reduces a magnet’s lifespan when the magnet coating chosen is not ideal for a particular medical device application
  2. Wasting time trying to circumnavigate ISO 13485 requirements and filing for FDA and MDR compliance
  3. Hitting walls due to a lack of access to the necessary equipment, space for micromachining, or the assembly of magnetic medical parts within a clean and compliant environment
  4. Uncertainty and mistakes due to the lack of in-house experience required to manufacture the magnetized medical parts 
  5. Incorrect specifications in your medical device design due to a lack of familiarity with a broad range of magnetic variables. Creating a component with avoidable stray magnetic fields

Problems with design for manufacture (DFM), FDA and ISO compliance, magnet coatings, and the urgent need to get the medical devices to market start to emerge and can prevent engineering teams from creating the highest quality components and products.


Considerations for Optimal Magnetic Medical Device Design

A few considerations regarding a magnetic medical device’s therapeutic, diagnostic, or medical end-use, and the ability to manufacture at scale should guide engineering teams. These include choosing the suitable materials, supply chain stability, selecting the right coating, part size optimization, incorporating a reasonable design margin, and many more.

  • Choosing the Right Materials

When manufacturing a medical device, finding the suitable material is a crucial step that calls for knowledge of manufacturing constraints, budget, supply chain logistics, and physical performance. You must also evaluate the material’s physical, chemical, surface, and rheological properties. Biocompatible materials include Parylene, Titanium, Gold Bioglass, Alumina, Hydroxyapatite, Medical Grade Silicone, Polypropylene, and others.

  • Selecting the Right Coating

Choosing a suitable coating increases the effectiveness of your medical parts. It is advisable to pick a biocompatible coating material with corrosion resistance properties. Anti-corrosion provides an extra layer of protection by limiting the contact between corrosive materials and chemical compounds. View Dexter’s guide on biocompatible coatings here to learn more. 

  • Supply Chain Stability

Fractured supply chains can disrupt the production or distribution of medical devices. Before manufacturing medical parts it’s important to consult experts from a provider like Dexter Magnetic Technologies who have access to a sizable supplier network. Following disruptions to the supply chain, Dexter can assist you in changing your strategy, and part design, and quickly pivot your production capabilities while working with you to maintain regulatory compliance. Dexter also has levels of vertical integration to minimize these risks. 

  • Part Size Optimization

The demand for smaller medical devices is on the rise. However, many teams get stuck facing false part design constraints due to perceived limitations around the right magnet for their application. Engineers who produce medical parts can work with a medical magnet expert to  assist them in optimizing their designs, parts, and processes, to remove all possible roadblocks between them and the team’s true vision for their device to meet consumer demand. 


How Dexter Assists with Magnetic Medical Device Manufacturing 

Dexter’s engineering and manufacturing experts will help you integrate robust, quality magnetics into medical device manufacturing. We will partner with your medical device R&D and engineering teams to eliminate challenges that affect optimal medical part design and manufacturing.

Our comprehensive approach covers your product’s lifecycle from design, material and part supply chain, production including quality controls, and the ability to produce in a clean environment. We have the resources and expertise to help you optimize and integrate magnetics while ensuring you comply with ISO, FDA, MDR, and other medical requirements while meeting market demand. Our commitment is to help you efficiently produce even the most difficult-to-manufacture medical parts of the utmost quality.

Use Dexter Magnetic Technologies As Your Medical Magnet Provider

Medical device makers who incorporate medical-grade magnets into their parts or assemblies constantly face a variety of difficulties. Due to rising consumer demand for ever-smaller medical devices and the latest developments in medical technology, manufacturing medical parts is becoming more challenging. The right components must be chosen, the best coating must be used, and size optimization and supply chain stability must all be taken into consideration when making medical parts.

Our committed teams work closely with you to define needs, validate system requirements, and produce optimized solutions throughout the project, with the end goal of enabling you to advance technology, achieve more tremendous success and enhance healthcare. We have the in-depth knowledge necessary to understand the specific requirements that manufacturers must satisfy to obtain FDA, MDR, or CE approval through our work supporting market leaders in the medical sector. To arrange a meeting with a magnetic specialist from Dexter, click here to get in touch with us right away.