The medtech industry is in the midst of unprecedented transformation in terms of treatments, technologies, and patient experience. As a trusted advisor, power supply providers collaborate with original equipment manufacturers (OEMs) as partners, with the provider offering new product capabilities developed in response to OEM and end-user needs. By forming partnerships with trusted suppliers, we can overcome the barriers to future device development while responding to industry and patient needs.
By forming partnerships with trusted suppliers, we can overcome the barriers to future device development while responding to industry and patient needs.
Where Care is Delivered
Rapid Development and Regulations
The Patient Experience
Device Trends and AE
Big Data and Artificial Intelligence
Medtech Macro Trends
The medtech industry is in the midst of unprecedented transformation in terms of treatments, technologies, and patient experience. To begin with, the nature of healthcare is shifting in response to changing patient profiles. One factor is the aging global population; people simply are living longer than in the past and require more (and different) care.
However, seniors aren’t the only group exhibiting changing healthcare diagnostic and treatment needs. The prevalence of diabetes (Type 2 and Type 1) in people ranging in age from 20 to 79 is projected to increase by 54% between 2015 and 2030. Hypertension follows suit, with a steady increase in “the burden of hypertension” across all age groups.
The global medical device market is expected to reach an estimated $409.5 billion by 2023, and it is forecast to grow at a CAGR of 4.5% from 2018 to 2023.
There’s a cultural shift as well. While cosmetic surgery has been with us for decades, younger people are more determined to fight the effects of aging. They are opting for modern cosmetic procedures, executed with lasers for skin treatment and ultrasound for body sculpting. Hair removal, liposuction, acne treatments, and skin tightening of middle-aged and younger people are gaining popularity. One interesting data point is that the global hair removal device market size is expected to reach $3.4 billion by 2025, expanding at a CAGR of 14.9%.
Where Care is Delivered
Where patients get care is changing—the hospital is no longer the de facto setting for many procedures. Outpatient treatment is not just more economic, it’s safer for patients, who are less likely to be exposed to bacteria and viruses in outpatient setting. At any given time, approximately 1 in 25 inpatients are afflicted with a hospital-acquired infection.
The hospital of the future probably will be quite different from what we know today, set up to treat acute illnesses and emergencies. Caregivers will need mobile diagnostic and treatment devices. The “house call” will return but happen via video over a computer tablet, which also will help overcome the shortage of healthcare resources plaguing rural areas.
Sales of wearable technology are expected to surge in the coming years, with the market set to reach $150 billion by 2027, according to market research and business intelligence firm IDTechEX. The Apple Watch has been recognized by the FDA as an electrocardiogram and atrial fibrillation monitoring device. While not a substitute for remote monitoring often prescribed after palpitations, wearables are significantly less expensive and can provide life-saving data.
Sales of wearable technology are expected to surge in the coming years, with the market set to reach $150 billion by 2027.
Rapid Development and Regulations
A traditionally risk-averse industry with slow regulatory change is giving way to rapid device development and more frequent regulatory revisions, standards ensuring device performance as well as safety for doctors, nurses, technicians, and patients. The 3rd Edition of IEC 60601, adopted in 2012, requires providers to demonstrate that they have a documented risk management system in place to verify device safety, including safety relevant to the device power supply. The EMC related 4th edition, in effect as of January 2019, includes emphasis on “intended use environments,” which are professional healthcare, home healthcare, and special environments— locations in which equipment will probably encounter electromagnetic interference.
Environmental sustainability has become part of healthcare providers’ mission. Progressive facilities take a holistic approach, setting “green” goals for every part of the organization. For example, using hydrogen peroxide transformed into plasma under controlled conditions is now a proven process that offers hazardous materials disposal advantages compared to other chemical sterilization techniques. Ozone sterilization systems are another option, providing a sustainable oxidative agent for destroying germs, viruses, and microbes that cause contamination.
The Patient Experience
We began this white paper with a remark about the changing profile of patients. Aside from age and needs, patient expectations are changing dramatically. Costs have risen and insurance providers are moving more of the financial responsibility to policy holders. Today, patients are consumers more than ever before, and as such are highly sensitive to the cost and value of their experience. That puts clinics and hospitals into the same position as retailers or software companies—success is measured to a degree based on “satisfied customers”—and healthcare providers compete for revenue. Medicare payments are also determined by the quality of care delivered to patients assisted by the program. Currently more than 44 million people benefit from Medicare.
Medtech Device Trends and Advanced Energy
All of the trends we’ve discussed are driving innovation in devices designed by imaging companies such as Siemens, GE, and Philips, medical laser providers including Solta and Ulthera, and electromedicine providers such as Medtronic and Johnson and Johnson.
Data, in one way or another, affects the future of medtech. Data from devices in all the “intended use” environments impacts care plans, treatments and outcomes, including the feedback from patients and healthcare professionals that defines user experiences and value-based compensation. The challenge is coping with the volume of data, extracting valuable information, and using that information to inform next-generation device design.
Big Data and Artificial Intelligence
Design engineers need to approach their solutions from two perspectives: collect and deliver data relevant to the health of the patient, and collect and transmit data from the device itself to enable system performance monitoring and device control.
The power supply can contribute device health data in real-time via digital communication. For example, even small changes in the heat generated can raise a red flag. By comparing historical data to other supplies, you can determine if the supply itself is failing or if there is an issue with the system. What’s more, the FDA is using “real world data” (as opposed to data from clinical trials) to help shape future medical device requirements because it opens “powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients.”
Real world data is valuable for OEMs, who can leverage it to speed product development. In a 2018 survey of medtech companies by Deloitte Center for Health Solutions and AdvaMed, 77% of R&D leaders said that leveraging real-world evidence (RWE) in product development was key to innovation, improving margins, and reducing cost.
Advanced Energy is building digital control into the power supplies to facilitate greater device control, device health status monitoring and data collection. The information gathered through that capability also informs risk analysis and helps address IEC 60601 regulations. Making power supplies even smarter is the next step. Artificial intelligence will enable the device to not just report issues but take action to correct the problem or, if necessary, shut down.
77% of R&D leaders said that leveraging real-world evidence (RWE) in product development was key to innovation, improving margins, and reducing cost.
With the “point of care” shifting from hospitals to clinics, homes and even retail establishments such as CVS or Walmart, device portability is a differentiating product feature. The GE VividTM E95 4D cardiovascular ultrasound system, for example, allows imaging and data transmission wherever the patient is.10 A high density, small footprint power supply is essential for achieving the advanced capabilities and making the device easy to maneuver for the user. Regulations are relevant as well; the power supply must be certified for use in different treatment settings.
At about the size of a credit card, AliveCore’s KardiaMobile 6L EKG reading device shows how small and portable some medtech devices can be. Install the app that links the 6L to your smartphone, put your fingers on the device, and you’ll get a medical-grade EKG recording in seconds. Advanced Energy’s connection to this type of device is more like to be to the semiconductor fabricator than the power supply; we’ve included this example to give perspective on just how small, how portable the devices of the future could be.
Multi-functional design is another strategy for cost reductions, since a device can be applied in different procedures. Lasers used in skin treatments are a good example. With a flexible power supply, a single device can be used for hair removal, ablative laser resurfacing for treating those pesky “crow’s feet” or eliminating unwanted tattoos. Equipment manufacturers need a scalable, accurate power source that can easily adjust for each application integrated into a single device. Again, digital communication is important to scalability; through real-time monitoring, users can be assured that the device is operating as needed for the application and their patient is safe.
Advanced Energy has developed several lines of power supplies that offer a range of voltage outputs for medical applications. These low voltage supplies have been designed for multiple applications and tested to ensure they meet IEC60601 requirements. At a high level, our goal is to make sure the supplies we offer today provide a platform for yet-to-be-imagined medical devices of tomorrow, whether that’s for a single application or multiple tasks.
Innovation is of no value if the end-product isn’t highly reliable. Power supplies need to be smaller, but first they need to be reliable. The first step is to develop high-efficiency power supplies; then power providers can shrink the footprint, preserving reliability while reducing footprint.
In addition to increasing supply density, engineers can look for device components that tend to fail. The cooling fan is typically one of the weakest elements in a power supply. Furthermore, it is a source of noise that often adds stress for patients in what is already a difficult situation. We’ve been able to eliminate fans by designing power supplies that use natural convection. Cooling without fans also eliminates vibration, a great advantage in highly sensitive imaging or other diagnostic procedures. Our CoolX1000, for example, has demonstrated MTBF > 400,000 hours, 25% better than many other solutions. We also employ a Design for Reliability paradigm in our development process which, although not unique to AE, results in robust products that deliver value to OEMs and end users alike.
With payments tied to value-based care and outcomes, the patient experience has become top of mind for healthcare providers. It’s given rise to a new C-level position in hospitals: the CXO, or Customer Experience Officer. The technologies they evaluate are wide-ranging, including the devices patents interact with during their stay. As discussed, we have developed fan-less power supplies for medical devices which run quietly, which helps lower the anxiety of patients during treatment. It’s those kinds of changes that influence CXOs and their colleagues to opt for one type of device over another.
The user experience dovetails with the patient experience. It’s critical for OEMs to offer devices that doctors, nurses and technicians actually enjoy operating. Even better overall experience is on the horizon, driven by AI, natural language processing and machine learning. Seamless interaction with users promises to improve processes by continuously enhancing the collaboration between man and machine. The outcome, an idea integral to the healthcare industry today, is a winning experience for all who are involved, in the hospital, clinic, “big box” medical facility or at home.
Medtech companies walk a fine line between protecting their intellectual property, their competitive edge, while also exposing their needs. As a trusted advisor, power supply providers collaborate with OEMs as partners, with the provider offering new product capabilities developed in response to OEM and end-user needs.
In an ideal world, providers have access to OEM research and roadmaps. But we are not working in an ideal world. The partnership between OEMs and providers hinges on the skills that the provider brings to the table and their understanding of easily identified as well as hidden needs. That means engaging in research of a changing market and leveraging special technology expertise to answer questions relevant to increasing and decreasing power needs, higher precision power, plasma generation, and faster transient response—just to name a few power supply characteristics that direct power supply design. It also means engaging in a form of ethnography, in which the provider studies engineers using the products in their labs to see the workarounds that they execute when a product doesn’t precisely meet application requirements.
Let’s ground the discussion with an example. A few years ago, we noticed that our medtech customers were incorporating touch screens into devices. The touch screens in those next-gen devices need 14 watts or so to function and our customers were buying power sources, in addition to the main power supply, to power the touch screen. As a result, we began offering a 25-watt, always-on, regulatory compliant auxiliary power supply integrated with our main power supply, which is currently unique in the marketplace.
Advanced Energy seeks to engage with all our customers as a partner. Working in concert, we can overcome the barriers to future device development while responding to industry and patient needs.
Source: Advanced Energy