January 31, 2024

The Crucial Role of Material Selection in Medical Device Contract Manufacturing

Contract manufacturing is often the best option in the medical device industry. It lets your company keep up with technological changes while reducing the need for expensive capital equipment. Contract manufacturing for medical devices also takes the strain out of maintaining and upgrading that equipment. Even with these advantages, you need to watch one aspect of medical device manufacturing closely: material selection.

The materials you select play a critical role throughout the lifecycle of a medical device. From product design and testing to regulatory compliance and production, your choices influence the success of medical devices. Plus, materials used in the manufacture of medical devices can influence customer choices.

You expect a contract manufacturer to pay attention to safety, durability, and performance when choosing materials. But with supply chain concerns and costs to consider, manufacturers must carefully weigh the options. You can't take material choice lightly with so much riding on it. This guide will educate you about material selection and how contract manufacturing can help.

Material Requirements for Medical Devices

Those involved in medical device manufacturing know that many regulations must be considered. This extends to materials and material selection. Above all else, you must keep in mind the Food and Drug Administration's material requirements for medical devices. The FDA routinely updates these regulations in response to scientific advancements and industry feedback, but these general principles always apply:

  • Biocompatibility: Medical device materials must not harm the body through chemical or physical interactions, even in the case of long-term implants.
  • Suitability: Material properties must match the device's function and withstand expected stresses.
  • Manufacturing quality: Consistent and controlled manufacturing processes are crucial to ensure material consistency and safety.
  • Labeling: Device labeling must include material data, including potential risks and limitations.
  • Good Manufacturing Practices (GMPs): GMPs help your company establish quality control procedures for material selection, testing, and handling.

In addition, the FDA provides guidance and resources for various material categories like metals, polymers, and ceramics. Monitor the agency's Medical Device Material Safety Summaries page for the latest information and updated guidance.

The Factors That Influence Material Selection

After the FDA requirements are satisfied, you can consider other factors that influence material selection. While the FDA guidelines are safety-focused, patient health should still take precedence. The finished product must not cause any toxic, allergic, or irritating reactions. Each material also has to undergo repeated sterilization without degradation over time.

Beyond safety concerns, you want materials suited to the device's purpose and functionality. Here, you consider material properties like flexibility, electrical conductivity, and whether the material can be molded to match the device design. There is also longevity, as the life of the material must equal or exceed the device's life expectancy. Compliance with international standards such as ISO 1099: 2017 ensures the device follows industry-standard practices. In addition, global regulatory compliance often requires documentation of material origins.

Of course, the costs of materials are an important factor. While you can't place price above regulatory concerns and patient safety, cost-effectiveness helps ensure profitability. This goes beyond the straightforward cost of the materials. Manufacturing considerations like shaping and machining the material can add costs to developing medical devices. Disposal and recycling fees can also negatively impact a material's cost-effectiveness.

Commonly Used Materials in Medical Device Manufacturing

You may be able to speed up your evaluation process by starting with the most commonly used materials in medical device manufacturing. They all meet regulatory requirements in most cases and are well-suited for diverse purposes. For instance, stainless steel is frequently selected because it's non-toxic, durable, and easily sanitized. Other popular materials include:

  • Copper: While copper isn't generally chosen for implant devices since it can be toxic to human tissue, its natural antibacterial and antiviral properties make it an excellent material for many other types of devices.
  • Titanium: Titanium is seen as a light and strong alternative to stainless steel and can also be metal 3D printed for easily customized parts.
  • Aluminum: Even though it's rarely used for devices that contact the human body, aluminum is a staple of medical devices, such as wheelchairs, IV stands, and bed frames.
  • Magnesium alloys: Since magnesium is both safe and biodegradable, magnesium alloys are used for applications as varied as temporary stents and bone grafts.
  • Gold: Gold has been a medical metal for all of recorded history, thanks to its corrosion resistance and strong biocompatibility. However, it is a rare material and can be very expensive.

Challenges in Medical Device Material Selection

You can encounter numerous obstacles while searching for safe, regulatory-compliant materials that meet all your device requirements. Balancing material strength, biocompatibility, flexibility, and cost can seem impossible at times. Then there are the unforeseen concerns, such as previously unknown interactions with the human body or other components.

While new innovations promise to meet all requirements, innovation comes at a cost. Long-term safety testing and clearing regulatory hurdles can delay the time it takes for materials to make it to the market. New materials also face the long climb of regulatory approval. This can be incredibly challenging as regulations change or vary across the globe.

As the past few years have shown, supply chain considerations present another roadblock in material selection. Global events and geopolitical instability can stop the flow of materials without notice. You need reliable access to materials for uninterrupted production, but that's not always guaranteed.

Diverse sourcing strategies and maintaining high inventory levels can help mitigate disruptions, although you will compete with other companies attempting to stockpile materials. Research from Mordor Intelligence shows unprecedented growth in healthcare spending in the United States — more than four trillion dollars annually — so competition for materials won't end anytime soon.

The Future of Materials in Medical Device Manufacturing

As with nearly every industry, technology is rapidly changing the medical device market. The recruiting firm Medical Engineers reports advancements in medical technology started a trend of miniature medical devices. This includes compact external defibrillators, portable oxygen concentrators with continuous pulse-dose delivery, and the world's smallest heart and lung support systems.

Expect to see a wealth of new wearable medical devices make it to market, including those that detect heart rate, blood pressure, oxygen saturation, temperature, respiration levels, and more. The Internet of Medical Things (IoMT) accounts for a lot of new technology in healthcare settings, tracking everything from medication orders to hospital admissions. Many of these small devices are possible thanks to recent advances in 3D medical printing.

This points to overall trends in the medical device industry of customization and personalized medicine. Wearable devices and highly portable equipment enable treatments specifically developed for each patient. This means many new materials will enter the medical device manufacturing space. Instead of the standard stainless steel, copper, and gold, you might now consider materials usually associated with electronic devices.

As many of today's devices rely on advanced technologies, component selection for smart materials, computer chips, silicon wafers, and electronic components are elevated to the same importance as materials. Today more than ever, consumers are concerned with sustainability — so take time to assess how green your suppliers are.

Selecting Medical Device Materials (and the Right Contract Manufacturer)

Medical device manufacturing requires a delicate balance between new technologies, a rapidly changing supply chain, and material selection challenges. Contract manufacturing of medical devices can alleviate many of those challenges — but only with the right partner. You need an expert manufacturer that understands the industry, global sourcing strategies, and modern, sustainable manufacturing.

Here at Sanbor Medical, we understand the challenges that surround medical manufacturing, including the critical task of material selection. We offer decades of experience and cost-effective solutions for the medical device industry, from concept to material selection and manufacturing. To learn more about our medical manufacturing capabilities, contact us today.

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