Well into the 21st century, the medical industry faces a host of intriguing challenges, from aging populations to a growing range of personalized and at-home diagnostic and care devices—all set against a backdrop of increasing digital collection, transfer and storage of sensitive patient data.
Medical manufacturers are rapidly adapting to this new reality. Additive manufacturing, or 3D printing, is being ramped up to higher production levels for a range of medical device parts. More devices are designed to be convenient for patients, collecting and transferring vital information for remote diagnosis and monitoring. This is leading medical brand owners to implement a slew of security practices to design for and manage data within the growing Medical Internet of Things (MIoT).
A survey of medical manufacturing experts illustrated the exponentially expanding repertoire of production practices and responsibilities that are leading to innovations in health care delivery.
When it comes to navigating emerging opportunities in medical manufacturing, consultant Mark Bonifacio knows first-hand the complex calculus involved in maintaining the right product mix and qualifications in the ever-evolving industry. This becomes even more important as debate intensifies over value-based versus fee-for-service models of healthcare delivery.
Bonifacio created his own medical contract manufacturing firm, APEC, in 1997 and sold it in 2007 to Freudenberg Medical, Carpinteria, Calif. Now, his Bonifacio Consulting Services, Boston, guides companies ranging from single-owner contract fabricators to Fortune 500 OEMs as they strategize how to maximize profitability in an industry where components like bone screws are increasingly commoditized and their margins are narrowing.
“There’s a big divergence taking place between the commodity side of health care in medical devices as opposed to the innovative side” of Class 3 devices like catheters and heart valves, which are subject to the highest amount of risk during use and are subject to the strictest FDA regulations. “We’re reminding our customers that in this new world, it’s obviously far better to be playing in that high-tech side of the device world from a margin perspective,” Bonifacio advised.
Leveraging one’s core manufacturing competencies in new ways is key, he added—especially as the medical device supply chain is consolidated and approved suppliers lists expand or contract. Acquisition of complementary technology providers or suppliers operating near a medical brand owner’s assembly facilities is an increasingly viable tactic.
“We’re advising some companies that they might need to acquire their way in” to accessing a given device space or customer, he said. “OEMs are sometimes asking a supplier to do more, to maybe manage some of the sub-tier suppliers” rather than simply rely on specializing in just injection molding, extrusion or metalworking.
Illustrating the principle of growing capabilities wisely is this year’s acquisition of Arcor Laser, Suffield, Conn., by medical contract manufacturer Cadence, Staunton, Va., which now can offer its customers laser welding, drilling, cutting and marking.
“It’s certainly a seller’s market,” Bonifacio said. And, “if you’re doing something higher-end that other folks can’t do in that med tech ecosystem—offering something that is going to make you stand out—you’re going to almost give no choice to that OEM to add you” to its roster.
In terms of specializing, he noted the case of Phillips-Medisize, Hudson, Wis., acquired by Molex, Lisle, Illinois, which “planted its flag” with its capabilities in high-end drug delivery—for instance in cold-chain supply, in which drugs are put into devices at a manufacturing facility.
Another emerging area is artificial intelligence (AI) for medical diagnosis, one of many potential digital care-delivery technologies in roughly the same sphere as Intuitive’s da Vinci surgical robots, with which surgeons conduct minimally invasive procedures remotely using the robots’ increased range of motion. AI has entered the home diagnosis market, for instance with the diabetes management system from One Drop, New York. The system’s Bluetooth glucose meter is combined with sensors and an app to monitor a user’s blood sugar levels, predict levels over the next 24 hours, and suggest ways to manage them.
Ultimately, with commodity medical items, Bonifacio suggested that manufacturers might have to admit “that ship has sailed,” that “there’s not a lot of innovation there (and) the margin is going to be what it is and probably get compressed even further.” Now more than ever, it is time for medical manufacturers to begin having conversations either internally or with external advisors to “think about what’s in front of you and maybe out three to four years.”
Growth areas for manufacturers include at-home patient diagnosis and customized patient care, fueled by 3D printed custom implants and surgical guides; digitally connected monitoring devices; and more sophisticated gene analytics. Developments in these areas are creating new opportunities and partnerships.
“We’re seeing a lot of integration between the medical device and the pharmaceutical industries,” noted Allyson Hein, medical device industry lead for Clarkston Consulting, Durham, N.C. The firm is fielding more requests for “combination” products and seeing pharma companies adding medical devices to their portfolios.
Given the disparate regulations governing pharmaceutical or biotech products and medical devices, refining quality management systems for manufacturers becomes crucial.
Clarkston reviews “every corner” of its customers’ QM systems to determine if they have the appropriate measures in place “that an inspector for a medical device regulation is going to look at that may not have been as much of a priority for someone coming out of the pharmaceutical industry,” Hein explained. “How you design a medical device is different than how you are going to market a new pharmaceutical or biotechnology product.”
These evolving combination devices will require manufacturers to expand their control systems to address regulations specific to the ISO or CFR standards or FDA Corrective and Preventive Actions board review. Harnessing enterprise resource planning (ERP) software is essential, for instance, to measure and monitor your supply chain, from acquisition of raw materials to storage, testing and eventually shipping. Makers of combination devices also must reconcile which regulations take the lead and where required unique device identifiers or serialization numbers will be marked.
In short, accounting for every step of the medical manufacturing process, from vendor to end user, not only ensures patient safety but also protects manufacturers by codifying the integrity of their processes. This even applies to mobile apps or other software that might originate as entertainment but evolve into something patients and even doctors might rely on to make decisions. In such cases, “you’re becoming a de facto medical device. Just because it’s digital doesn’t mean it’s not a medical device,” Hein cautioned.
Consumer-based health care will drive far more personalized devices, she concluded. “As consumers, we have a greater demand for something that’s specific for us,” she said. “People are asking, ‘Why do I have to go to the doctor’s office when there can be telemedicine, or I can have a device in my home that can communicate data and results to my physician?’”
Demand for medical products is increasing at such a pace that manufacturers are seeking assistance to scale up their production from, for example, 10,000 diagnostic cartridges a month to one million, said Etoli Wolff, vice president of sales for Owens Design, Fremont, Calif.
For most of its 35 years, Owens Design focused on high-tech manufacturing, such as hard drives, semiconductors, clean energy and emerging technologies, Wolff explained. However, due to the cyclical nature of that business, the company diversified into the life sciences about five years ago.
Many of Owens’ customers are in the Bay Area and focus on point-of-care diagnostic devices, which require plenty of consumable components, primarily the cartridges used to conduct tests. As demand for those devices grows, companies call on Owens to manage their expanding production requirements.
“Many times our clients do not have the internal resources to get up to speed and quickly come up with a ramp-up solution,” Wolff explained. Some customers aren’t yet in production and need help starting production to take a product to market.
For established manufacturers, Owens first replicates their exact production methods to assess how to expand them without requiring a new FDA approval. For startups, manual assembly in the lab must be translated into an automated process. Owens designs and builds an automation system, and customers conduct a trial run in Owens’ facility before the assembly line is shipped to the customer.
These pick-and-place lines inspect parts with vision systems, insert chemical reagents that diagnose pathogens, then assemble multiple injection-molded parts into the final cartridge. These fully custom systems can speed throughput from about one part a minute to one part every 10 to 20 seconds and manufacture not just diagnostic devices but things like applicators.
Owens is a critical partner for medical manufacturing thanks to its expertise in designing controlled processes for semi-conductors, where precision machines must meet tolerances down to the micron and sub-micron level, he said, noting that biomed technology is perhaps about 10 years behind semiconductor technology—but gaining fast.
“Every one of those customers needs a well-defined process” at the beginning, he advised, “because if their process is faulty, automation will not fix it.” Ultimately, the medical market is “huge,” with more opportunities coming in Asia and the Third World. And, “it is less cyclical than I’ve seen in other industries” due in no small part to FDA regulatory requirements enforcing a steady pace.
In a little more than six years, GE Healthcare’s additive manufacturing team in Waukesha, Wis., has grown from the exploratory stages to building a 3D printing culture in which designers well-versed in various processes are embedded in engineering teams across the business.
Jimmie Beacham, chief additive engineering leader for GE Healthcare, is leading that charge, through there area host of challenges—like the fact that “99 percent” of the company’s engineers did not study AM in college and most engineers’ perception of it was developed from exploring simple rapid prototyped plastic parts.
“Additive is fairly new when it comes to functional printing,” he explained, in terms of “having the ability to print parts that have the strength and functionality that we need to make devices.”
Expanding the reach of 3D printing means that medical device manufacturers must “unravel many years of what engineers have learned around subtractive manufacturing. They’ve all had some design that they sent to a supplier or a machine shop, and the machine shop came back and said, ‘No, you can’t do that.’”
Now, not only has 3D printing expanded beyond the early days of rapid prototyping of form and fit, it can now deliver function, which accelerates serial production of functional parts.
For instance, GE Healthcare has a couple of medical components going into production this year that will be made in the tens of thousands annually with selective laser sintering (SLS). Depending on part volumes, surface finish requirements and the manufacturing environment, GE will also incorporate the appropriate level of automation and other advanced manufacturing technologies.
“We’ve seen a huge acceleration of applications in additive for our medical devices,” primarily components for diagnostic equipment, Beacham noted. By the end of 2020, he expects more than 20 parts to progress from design stage to production with a funnel of over 100 components being designed for AM. Additive becomes the more attractive choice vis-a-vis other production methods when it can exhibit:
With more than 40 engineering teams designing components across GE Healthcare, Beacham has a cross-functional team of three additive program leaders, an additive supply chain strategist and process experts who interact with those teams across the organization’s three business units. The design-for-additive culture is built through regular training seminars and “additive summits,” at which engineers bring problems to the table that could not be solved with traditional manufacturing.
Bolstering this effort is a process team expert at “almost all modalities of 3D printing” like metal binder jet, direct metal laser melting for stainless steel, titanium, aluminum and tungsten, as well as methods for polymers, including fused deposition modeling, SLS, stereolithography and poly jet.
Printing electronics is another GE Healthcare specialty, using the direct write process. A finely controlled aerosol stream of nanosize metal particles in a solution is sprayed onto 3D surfaces. The particles are sintered to form electrical circuits that conform to a shape. One advantage is being able to print antennas and sensors in unique places in a manner never achievable or cost-effective before.
“The perception of additive in general is that it is good for low-volume, high-mix parts,” Beacham asserted. “The reality is changing quickly,” especially as 3D printer OEMs increase the speed of their equipment. Plastics printing is approaching injection molding volumes, he added. In terms of regulating 3D printed products for patient safety, “the FDA has been very proactive in trying to understand it (and) avoid extra risks”—especially in the case of monitoring a slew of unique, patient-specific implants as opposed to mass-produced components.
Ultimately, additive “is like any other process,” he concluded. “We have to exercise the right design rigor and process controls (like powder monitoring and the printing process) to verify that any product or part we make is safe and effective and meets customer requirements and FDA guidelines.”
When Steve Abrahamson became GE Healthcare’s senior director for product cybersecurity, he was the only person working on the topic there for about three years. Serving in the role for about nine of his 22 years with GE, Abrahamson now is part of a business-wide cadre of more than 100 product security leaders (PSLs) and product security representatives (PSRs) who extend throughout the organization, ensuring data security is top of mind from product concept to design to manufacture.
“We have to think about risks to patient safety because security issues can have an impact on patient care,” he explained. “We have to consider data privacy and device availability.”
GE Healthcare’s internal security experts operate under GE Healthcare’s Design Engineering for Privacy and Security (DEPS) process, which ensures that “we determine the right security requirements to build into the design specification” of all applicable GE medical devices. PSLs interact directly with their assigned engineering teams, while PSRs function within those product engineering teams to ensure DEPS practices are followed.
DEPS stipulates detailed analysis of medical device risks by addressing factors such as whether a device stores protected patient information, how much, and if there is a defined purpose for collecting that data.
“Based on those levels of risk assessment, we integrate into the design specification features called security controls,” which, for example, might authenticate users or ensure they have the appropriate level of access to specific device functions.
Adding to the delicacy of managing emerging MIoT issues is the array of regulatory agencies monitoring risks along the spectrum of patient care. The FDA and its equivalents around the world regulate patient safety. But in the case of protecting patient information and data privacy, for instance, the U.S. Office for Civil Rights of the Health and Human Services department enforces the Health Insurance Portability and Accountability Act (HIPAA).
Not only that, but “we also work with the Department of Homeland Security in addressing general security issues that may not pertain directly to patient safety or data privacy but may be more impactful from a national security and critical infrastructure perspective.”
Manufacturers must be adept at managing all those “risk domains” and aligning with the expectations of those organizations.
“Our design process is very device-specific and risk-based. Whenever we go through product development, we look at all risk factors associated with how we expect the device is going to be used and make sure we are implementing the appropriate controls.”
Data controls are implemented based on whether devices are used in hospitals and clinics or at home, and whether they stream data to the cloud. Planning to support a given device through its entire useful life takes into account the software being used, its ability to be updated, and potential vulnerabilities. After manufacture, device performance relative to security risks can be monitored during use.
Spreading an MIoT security mindset throughout all phases of medical device manufacture is job No. 1, Abrahamson asserted. Several years ago, for instance, GE Healthcare implemented security requirements in its sourcing process to ensure suppliers have appropriate security programs. “We don’t want components with back doors or hidden malware and software to creep into our supply chain or manufacturing process.”
On a broader scale, he concluded, medical device security is very much an industrywide effort.
“We don’t want to compete (with other brand owners) on safety and security, so there’s a high level of collaboration. I know all the product cybersecurity people at the other major manufacturers. We share information and best practices, and we work with the FDA trying to fine-tune their guidances. We also have very good working relationships with our customers. We’re building toward more standard practices.”