Originally published on fastradius.com on August 24, 2020
Medical device manufacturers face unique challenges when it comes to product development because they’re trying to break into a very heavily regulated market with a lot of oversight. Since medical equipment has a direct impact on health outcomes, medical device manufacturing demands extraordinary attention be paid to product quality and ensuring that products can be safely manufactured with a high degree of repeatability. As such, the industry is strictly regulated.
The U.S. Food and Drug Administration, for instance, regulates the production of medical devices depending on the classification, from a class one through class three medical device. There may be additional regulatory requirements set out by the International Electrotechnical Commission (IEC), the International Standard for Organization (ISO), or the regulatory body in the country of sale outside of the US. Depending on the classification of the device, there are certain pathways that must be followed and filings that must be effectively completed. Achieving regulatory compliance should never be rushed.
Based on its heavily regulated nature, medical device manufacturing can be slow and methodical, relying heavily on traditional manufacturing technologies like CNC machining and injection molding. As a result, innovating in the medical industry is challenging. It’s not impossible, though. The following three medical device industry trends exemplify how medical device manufacturers are breaking barriers and switching their approach to deliver safe, accurate, and life-changing products in record time.
Three key medical device manufacturing trends
These medical device industry trends stem from a larger cultural shift toward patient-centric care. Patient-centric care, as defined by the Institute of Medicine, focuses on “providing care that is respectful of, and responsive to, individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions.” Numerous studies have shown that this care model reduces pain and discomfort, fosters faster recovery, and boosts emotional health. New, emerging medical technologies now focus on achieving these improved outcomes by embracing the patient-centric approach.
1. A shift toward less invasive surgical instruments, wearables, and at-home monitoring devices
The medical device industry — particularly the surgical sector — has continued a multi-decade march to less and less invasive therapies. Manufacturers continue to investigate the ways that innovations in technology can be used to produce superior patient outcomes using new, less invasive approaches. Less invasive surgeries result in faster healing, have fewer complications, and reduce rates of infection.
As the medical device industry continues its shift away from invasive procedures, the sector is also witnessing a parallel shift toward more preventative health devices like wearables and at-home monitoring devices. Wearables empower patients to regulate their own health, and many use them as a way to avoid invasive procedures in the future. In fact, according to a VivaLNK survey, 64% of surveyed respondents reported they would use a wearable health monitoring device if it meant they could reduce their number of doctor or hospital visits. Early detection, diagnosis, and treatment translates to far better outcomes that attempt to treat disease in later stages.
Many companies, inside and outside of the medical industry, are investing millions of dollars in developing non-invasive, patient monitoring devices.
2. An increased focus on personalized devices
Along the same lines, medical device manufacturers are zeroing in on personalized medical devices. The patient-centric care model holds that no two patients are exactly the same, and as such, no two medical treatments should be the same. As such, personalized medical devices are those designed to “prescribe the right patient the right drug at the right time” under a doctor’s supervision.
Additive manufacturing plays a major role here. Axial3D, a SyBridge partner, helps healthcare providers recreate exact replicas of a patient’s anatomy using advanced 3D printing technologies. They create the 3D models and we print them in our facilities. Surgeons utilize these models for pre-operative planning.
The insights they gain from the precise details of the printed anatomy allows them to modify their surgical plans to best fit that patient, and, as a result, improve long-term health outcomes. As an added benefit, utilizing Axial3D’s speed in 3D model creation and SyBridge’s production scale, healthcare providers can have these models in-hand faster than ever and at a much lower price point than legacy options, increasing accessibility to personalized care.
3. A shift toward on-demand manufacturing to accommodate customization
Long-term manufacturing models geared toward mass production aren’t compatible with the aforementioned medical device industry trends. As medical devices become more specialized and custom-built to patients’ unique needs and anatomies, the demand for low-volume production rises.
This need has inspired a shift toward on-demand manufacturing. This operating model is well-suited for manufacturing customizable products because it calculates production volume based on actual demand, rather than projections. This lowers inventory costs, enables greater product personalization, and accelerates production.
In the context of medical equipment, on-demand manufacturing allows manufacturers to get products to market faster without compromising regulatory compliance. Also, on-demand manufacturers can quickly pivot their operations in response to demand or unforeseen events, like repurposing a factory to create 3D printed personal protective equipment (PPE) to meet the unprecedented demands of the coronavirus pandemic.
Further, COVID-19 has driven innovation in the medical space by forcing manufacturers to simultaneously ramp up and fortify global supply chains. As evidenced by the initial shortage of PPE at the beginning of the pandemic and the current shortage of diagnostic testing methods, medical device manufacturers are feeling the pressure to create new solutions faster than ever before and at scale. With on-demand and additive manufacturing, manufacturers can create products as needed while alleviating the time and design limitations brought about by traditional manufacturing technologies.
Looking toward the future of medicine with SyBridge
As the medical device industry adjusts to the “new normal” post-COVID and navigates the aforementioned industry trends, we also expect to see a rise in personalized medicine informed by data in the near future.
We produce an extraordinary amount of data as we go about our lives, and healthcare providers can take that data and apply it to medicine to create more effective solutions that improve patient outcomes. Big data drives customized approaches and can be married with digital manufacturing to accelerate the production of effective medical devices and unlock new treatment possibilities. Future medical devices will dovetail nicely with emerging data-driven technologies.
Our partnership with Axial3D is just one example of how patient-centric care models and additive manufacturing are coming together to disrupt the medical device industry. The SyBridge business model — fast, scalable multi-process on-demand manufacturing combined with Industry 4.0 expertise — can readily meet the challenges faced by medical device manufacturers today. We want to help you get your product to market as quickly as possible so you can start changing lives. Contact us today to get started.