The global market for wearable medical products is rapidly growing, driven by both demographics and maturing technology. Fortunately for the industry, the liquid silicone rubber (LSR) market is uniquely positioned to grow right along with the increasing demand for these devices. LSR’s advantages will also help wearable medical devices clear the regulatory, technological, and economic hurdles presently holding back their adoption.

Demographics, Diabetes, and Global Demand

According to one recent forecast, the global market for wearable medical devices is projected to increase at a Compound Annual Growth Rate (CAGR) of 18% over the period from 2017 to 2023. In terms of dollars, this market was worth $2 billion in 2016, with the forecast predicting triple that number by 2023.

Wearable medical devices are used to monitor health parameters including blood pressure, heart rate, and blood glucose level. Those last two items are a major driver of the adoption of medical wearables, as an aging global population and other trends are increasing the prevalence of diabetes. In fact, the International Diabetes Federation notes that incidence of diabetes in the global adult population is growing at an annual rate of 8.4%, with 625 million diabetic adults worldwide by 2040. In the US, over 29 million people are diabetic according to the CDC, which in turn is propelling the demand in North America of wearable diabetes care products.

Shrinking Components

As the worldwide demand for wearable medical devices grows, the technology needed for them has continued to shrink. Computing chips, sensors, and wireless components continue to miniaturize, and this has opened the door to constant clinical monitoring at the health care facility, at home, or even outdoors.

Potential Shackles Impacting Medical Wearables

Despite these technological and global health trends, there are several factors hindering the increased adoption of wearable medical devices. Two of the most central are:

Proving the reliability of wearable medical products. The bar for wearable medical devices when it comes to dependable operation is significantly higher than it is for consumer wearables like FitBits. As Mike Bolduc, C&K’s the Global Marketing Manager for Industrial and Medical Segments explained last year for Medical Product Outsourcing, “Whereas consumer fitness trackers can help users stay in shape, medical wearables can detect life-threatening conditions, collect biometric data to help with patient diagnoses, and even administer medicine to alleviate pain. Thus, consumer wearables can be considered a superfluous indulgence while medical wearables are more mission-critical”.

With the wearable medical device industry still relatively young, there a lot of either clinical data or industry experience to confidently conclude medical wearables are as dependable as they will need to be.

Regulatory and compliance hurdles. In that same article, Bolduc also points out that medical devices must meet “meet stringent safety and accuracy standards” and that wearable medical products need to “be validated by U.S. Food and Drug Administration and ISO standards”. Wearable medical products used clinically to monitor blood glucose levels or measure irregular heartbeats will be given the same regulatory scrutiny as other diagnostic devices. Likewise, a wearable which administers a pharmaceutical agent will have to meet the same quality standards as other drug delivery products.

How LSR Can Benefit Wearable Medical Products

LSR can help the wearable medical device industry clear these two key hurdles and shorten the time to market for new medical wearables, which will be necessary to meet the projected global demand for these devices.

Medical-grade silicone is an excellent material for wearable medical product components. It boasts excellent biocompatibility, durability, availability in a wide selection of durometers, and compatibility with a vast range of sterilization and disinfection methods. All of these features make it a great choice for wearables which must be in prolonged contact with the patient, and durable enough to operate reliably wherever the patient goes. That proven durability can benefit the reliability of a whole wearable device, and thus help that device pass the required reliability testing.

High-quality precision LSR prototypes can be made economically and quickly when choosing LSR as a material.  This expediency results in more rapid design iterations, more thorough evaluation and testing of the design, and earlier completion of product development phases.

There is another way LSR can increase the speed-to-market of wearable medical products. LSR is compatible with injection molding, wearable medical product OEMs who incorporate it will more quickly ramp up production inventory to levels needed for meeting the worldwide demand expected in the upcoming years.

Besides accelerating the market debut of new medical wearables, LSR opens entirely new doors for them. For instance, the advent of electrically-conductive medical-grade LSRs makes possible wearable medical devices which provide external stimulation to nerves or muscles—a potentially huge untapped market. Such therapeutic devices which combine conductive silicones with wearable medical devices can deliver safe and non-invasive treatment for millions of patients.

Finally, medical-grade LSR is widely available and has a proven track record of safe, reliable, use in a plethora of medical devices, including long-term implantables. The medical device industry’s—not to mention that of regulators—experience with LSR means one less material in an OEMs’ supply chain to worry about meeting the stringent FDA requirements for clinical use.

As medical device companies rush to address the global need for medical wearables, LSR can provide the solutions OEMs need to satisfy the regulatory and other hurdles this new and rapidly expanding market is up against.

As a silicone-focused contract manufacturer of medical devices, ProMed has the LSR design and molding expertise needed to launch help these companies find those solutions. Contact us today and find out how we can help you.

The Wearable Medical Product Market & the Benefits of LSR for Speed-to-Market
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The Wearable Medical Product Market & the Benefits of LSR for Speed-to-Market
The global market for wearable medical products is rapidly growing, driven by both demographics and maturing technology. Fortunately for.......
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ProMed Molding
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