By Mike Bolduc, Global Marketing Manager, Industrial & Medical Segments, C&K
When it comes to medical device performance, it’s no secret that accuracy and reliability are top of mind. Whether it’s a blood glucose monitor for a diabetic patient or a surgical robot for a cardiac procedure, lives are at stake if these devices fail to function properly. While doctors get most of the credit for the work they perform with these tools, rarely do people think about what goes into these devices and how they are created in the first place.
Fortunately, there are teams of dedicated design engineers who evaluate the best components for each device—from the nuts and bolts that hold them together to the high-performance materials that are durable enough to withstand the challenging environments of most medical applications. However, this is no easy feat and there are many factors that come into play when designing a medical device. Given a host of design variables and the seemingly infinite material choices available, selection can be extremely complicated, costly and time-consuming.
To guide the selection process, design engineers should consider the “Five Ps”—performance requirements, personalization, product life expectancy, place and production factors—and how they are influencing the development of medical devices.
P1: Performance requirements
Performance, size and reliability are the name of the game when it comes to how a product will operate. Today’s medical devices need to meet very specific requirements. Let’s start with size. Small form factors are becoming increasingly more important, particularly with the convergence of wearables and healthcare. Products to monitor blood pressure, heart rate, blood sugar and oxygen levels—as well as accidents, falls and other emergencies—Medtech components: Why you need to eat your p’sare becoming the norm, and small size and light weight are a must to prevent interfering with a patient’s lifestyle. The addition of communication capability to support growing trends such as telehealth means additional circuitry such as antennas and transmitters, which leaves less room for traditional components, such as switches.
In addition to size, key industry trends are driving the need for higher performance and reliability. For example, minimally invasive procedures such as laparoscopy and robot-assisted surgery have become increasingly popular. This type of surgery calls for smaller incisions and higher precision. The medical products used for these procedures require switches and components that allow surgical personnel to accurately and reliably position, manipulate and actuate the various instruments and equipment. Small footprint, proper tactile feedback and resistance to body fluids are all key requirements for these components. And although it’s a challenge to create a device that takes up less space, meets specific performance requirements, and operates reliably for many years, it’s critical for patient safety.
With a massive number of suppliers and an even bigger catalog of commercial off-the-shelf components, sometimes it’s just a matter of finding the right fit. However, most design involves some personalization to provide the exact performance required. Although customizing components sounds expensive and difficult, many suppliers are willing to make modifications to existing products to save time, cost and complications down the line. A good supplier will take the time to understand the requirements of the application and make recommendations around the best way to integrate their component. Think of the supplier as a partner and collaborate with them to determine a realistic timeline, budget and how they plan to test and troubleshoot the part if it’s not functioning properly.
P3: Product life expectancy
Big changes are happening quickly in the medical industry. Just think about the increases in speed, miniaturization of feature size and changes in application requirements for user friendliness in recent years. While these advances are great for medical professionals and patients, it also means that many of the components that make up a product have a life expectancy that is significantly shorter than the product itself. It’s important to understand a manufacturer’s product roadmap and make sure their technology and portfolio investments are aligned with the requirements and trends of the specific medical application. Also, be sure to ask about product obsolescence and whether the manufacturer will even be making the same component in a year’s time. Both are important factors to consider during the design phase.
From blood and body fluids to harsh sterilization chemicals, medical devices—especially surgical and critical care equipment—need to hold up in a range of tough conditions. This is why corrosion resistance is one of the most important factors when narrowing down the appropriate components. Aside from the device’s functionality or how it will be cleaned, it’s critical to consider the environment in which it’s being used. For example, in a busy emergency room equipment is moved around quickly and personnel don’t always have the time to be gentle or use equipment as recommended. Designing durable components that can handle impact or excessive force allows the equipment to work reliably for years, even in challenging situations. Environmental specifications can restrict these choices, so it’s best to determine early on if this will limit your choice of components. Be sure to work with manufacturers to meet specific needs.
P5: Production Factors
Geographical concerns may seem low on the list of things to consider, but location shouldn’t be dismissed entirely. With a host of supply chain variables, as well as an OEM’s ability to communicate with the supplier’s engineering team during the design and development process, there are some real benefits to working with a supplier in close proximity. Global players, having locations in the region where the end product is manufactured allows the supplier to better understand the customer’s manufacturing process, which can lead to further ideas for component and product improvement. Ultimately, this can help both sides better understand the advantages and limitations of various product offerings as well as get specific recommendations as to the best way to integrate the component into the end device.
Although it’s no easy task, selecting the right component can affect a medical device’s usability, durability, longevity, safety and can significantly contribute to the time-to-market, as well as a product’s overall success. By using the “Five Ps,” design engineers can streamline the selection process, reduce the risk of costly and dangerous mistakes and most importantly, improve patient outcomes.
Mike Bolduc is Global Marketing Manager at C&K, where he is responsible for leading market strategy and global growth efforts for the industrial and medical business segments. Mike has an engineering and business background and over 25 years of diversified experience in the automotive, semiconductor, HVAC, aerospace, industrial, and medical industries working for large global corporations such as Texas Instruments and Stanley Black & Decker.
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