3-D printing holds all kinds of value, benefits, and possibilities for the global medical device arena. But a new day has not fully dawned for the industry. Here are four reasons why.
Bart Reitter, QAD
The medical device industry has a proven and storied history of innovation. From x-ray tubes and pacemakers, to CT scanners and mobile electrocardiogram monitors, the medical device sector has always embraced innovation with the goal of improving and saving lives. One of the recent trends in that evolution is the concept of additive manufacturing, or 3-D printing. Unlike traditional manufacturing involving machining, additive manufacturing does not remove material from a bare piece of stock. Rather, 3-D printing involves adding successive layers of material to form a 3-D object. This concept is exciting for the industry as it will change the way devices are developed, manufactured and delivered to patients.
When we at QAD (Santa Barbara, CA) speak to our medical device customers from around the world, we hear about the challenges they face and how they are addressing them. Some are concerned about their products becoming commoditized as the line blurs between highly-regulated and consumer devices. Many wonder how to differentiate their solutions among a wide range of competitive offerings from domestic and overseas competitors. Others know that surgeons expect companies to deliver holistic solutions that deliver tangible benefits, and that simple devices which meet single therapeutic needs may no longer suffice. In turn, hospitals expect device manufacturers to focus on how to make the operating room (OR) more efficient and how to improve OR turnover times and usage. The expectation is that new solutions will result in fewer patient visits and less time in the hospital, and reimbursement is often tied to those metrics.
Additive manufacturing can help address some of those challenges and promises to reshape the way device companies bring products to market. 3-D printing allows for rapid prototyping and optimized design of innovative new solutions. Such an approach helps insulate companies against competition and shortens product development lifecycles and time to market. Development and application of devices using 3-D printed anatomical models results in better planning for surgeries, greater physician awareness of device capabilities and limitations, and improved OR efficiency. In addition, the ability to print devices directly from specific patient imaging enables companies to deliver customized devices with improved fit and functionality.
According to the Food and Drug Administration's (FDA's) website, the agency has cleared more than 85 3-D printed medical devices as of December 2015. The applications range from orthopedic implants to surgical instruments and from dental restorations to external prosthetics. In May 2016, the FDA issued a guidance document titled Technical Considerations for Additive Manufactured Devices, and it is assessing the impact of current good manufacturing practice (GMP) regulations on device design and security.
Considering how rapidly manufacturers could make modifications to device designs without major retooling or turnaround times, the appeal of 3-D printing is huge. Further, the operational benefit can be significant. Reductions in capital equipment, inventory, and labor costs, as well as manufacturing cycle times, are all achievable benefits from embracing additive manufacturing. The very real concept of a medical device manufacturer carrying a year's worth of inventory may be a thing of the past as companies can deploy an army of 3-D printers to meet demand. In addition, companies can choose to retain the intellectual property for device design, and outsource the manufacturing to organizations dedicated to printing 3-D devices on a contract basis.
Yet, despite the hype, the excitement about 3-D printing isn't universal, and a new day has not fully dawned on the industry. Here are four reasons why:
1. Durability Concerns
Several of our customers have expressed reluctance or inability to incorporate the new technology into their processes, and with good reason: some implant manufacturers have expressed concern about the durability of 3-D-printed implants. Titanium alloys have a long and proven record as knee or hip implants, and perfecting a 3-D printed object is no simple task. Many organizations are unwilling to take that risk, and instead, rely on 3-D printing for support devices used during surgery.
2. Customers May Not Always Need It
Hospitals and physicians do not necessarily need custom or on-demand medical devices. Such devices would surely demand a premium in an age when hospitals have little money to spare, to say nothing about the payer perspective and how reimbursement would be handled. Off-the-shelf devices have served the industry for decades, and in many situations, they will be good enough.
3. An Expertise Shortage
Currently, finding professionals with expertise to support 3-D printing operations for products that need extreme precision can also prove challenging. Developing expertise in the use of 3-D printers takes time, and there aren't enough experts in the field yet. For the time being, those who want to incorporate 3-D printing find ways to accomplish that. One medical device customer surmised, "We could staff up, train and retain people to do nothing but observe, learn and practice, but we chose to go to a third party because they've got a full warehouse of 3-D printers."
4. Evolving Regulations
Lastly, the regulatory impact of 3D printed devices is still evolving. The FDA recently issued guidance for the manufacturing of 3-D devices, but the approval pathways such as 510(k) and Pre-market Application (PMA) will impact industry acceptance as well. The 510(k) method uses devices that are already on the market to evaluate conformance, and the PMA covers new devices, which, given the expected growth, is the pathway for most 3=D printed devices going forward. The PMA process also requires clinical trials and data to show a device is safe and effective in a large population.
Regardless of the limitations of the technology, the concept is exciting for the medical device industry, as it creates the possibility of new and innovative approaches for developing and manufacturing life-improving and saving devices. With the challenges of implementing 3-D printing in medical device manufacturing, it may take some time before the technology picks up enough momentum to be a "wave," but at the least, we can call the 3-D printing trend a steadily rising tide.