Consider, for just one moment, the ability to monitor human brain activity at its source. Imagine the knowledge that could be gleaned by directly observing the non-stop electric symphony composed and conducted by a 120 billion-piece neuronal orchestra.
 
Fancy gaining a ringside seat to this cerebral concerto, without the need for big, bulky machines, strange-looking skull caps, or long, tangle-prone wires. A tiny, perhaps flexible, electrode would suffice as the entrance fee.
 
To truly witness the magical harmony of the brain’s electric oscillations, that electrode would have to be extremely small—conceivably, 100 nanometers or so (roughly 1,000 times thinner than a human hair).
 
Creating an electrode of that size certainly is technologically possible. Medical electronics have steadily been shrinking over the last two decades as digital health and minimally invasive surgical procedures spawned a worldwide thirst for smaller, more complex computerized devices that improve diagnoses and tracking. The scramble for diagnostic tests, personal protective equipment, ventilators, and other medical supplies associated with the planet’s battle against COVID-19 is expected to increase demand for medical electronics over the next seven years.
 
Medical Product Outsourcing’s September feature, “Mission Complete,” details the various trends and challenges currently shaping the custom medical electronics market. Angel Lasso, senior director, Engineering Services, Engineering & Technology, at Jabil, was among the experts interviewed for this story. His full input is provided in the following Q&A:
 
Michael Barbella: What factors must be taken into consideration when designing electronic components for medical devices?
Angel Lasso: Jabil conducts a survey on digital health trends each year and we’re seeing a marked increase in development of products with electronics and other technologies. In 2020, 44 percent of companies reported having digital products in production, versus just 21 percent in 2018. This is driven by customer demand, adoption of remote care, value-base care (VBC), and calls for better clinical trials. It’s a new era for healthcare and we’re seeing that both in new tech-focused companies entering healthcare and the continuing integration of electronics and technologies into existing products.
Healthcare can look to other industries, such as consumer tech and transportation, for guidance and verification of winning strategies for meeting market requirements while still proactively addressing potential hazards and harms. Design that leverages modular product architecture provides the best course for an original equipment manufacturer (OEM) to ensure their products are keeping pace with evolving technology. The entire product management strategy must have supply chain impacts and issues at the forefront, or risk losing traction against faster, more agile competitors.
 
Barbella: Please discuss some of the challenges in designing and manufacturing electronic components for medical devices. How has your company overcome these challenges?
Lasso: Medical products will always have unique challenges with regulatory requirements, factory certifications, and validation standards. These are the concerns that have always been native to healthcare. The market’s shift embracing innovations in technology and connectivity have just added another layer. It’s also upped the ante on getting to market quicker and heightened the importance of being mindful of obsolescence risks for outdated components and electronics parts. Today, 41 percent of companies say their development and launch cycle for digital health solutions are less than 18 months, whereas only 29 percent said the same in 2018.
There are essentially two interlinked dynamics which must be navigated in tandem.
Accelerated time-to-market requirements and the expertise and insights for addressing the increased pace of innovation.
Historically, very long product cycles combined with relatively slow evolutions in therapy and regulatory concerns have established a ‘status quo’ market environment for medical device manufacturers. Meanwhile, pushing back on this hesitancy to change is the “digitalization of everything.” In fact, there are really no industries immune to the hyper-fast evolutions in technology. So, healthcare, as has been the case with automotive and consumer tech, now must adopt shorter product cycles in order to keep pace with the speed of technology.
Comprehensive product lifecycle management now requires being proactive, but perhaps more importantly, predictive to avoid interruptions in the production process. In today’s environment, design and engineering-focused product teams require strategic insights for managing risks in their supply chain, with an eye towards components or parts scheduled for end-of-life. At the same time, predictive analysis helps to identify the technology changes that are on the horizon so that necessary modular redesigns get traction early enough to help the OEM maintain leadership and competitiveness in their market.
In our survey, just over half of companies say they’ve built new teams with technology expertise and 44 percent have put in organizational structures to ensure better coordination across departments. Outsourcing areas that don’t traditionally fall in medical OEM’s strengths will be a strategy on the rise as demand for more sophisticated electronics and technology grows.
 
Barbella: What are customers demanding or expecting in their electronic components?
Lasso: There is no denying the market demand for products with the latest electronics and connectivity features—across all industries. Consumers today have real-time data on their sleep, steps, heartrate and more—so they expect more from their medical devices, too. Take note of the tech giants moving into the healthcare space in the last few years as proof of the opportunity: Apple has been acquiring health startups and companies since 2015 to elevate their health tracking capabilities. Amazon acquired Health Navigator in October 2019 and launched Amazon Care to its employees. A week after the Amazon acquisition, Google acquired Fitbit in November 2019 to make its mark within healthcare wearables.
Customers expect their contract manufacturers (CMs) to keep production going, but this can be challenging and costly to OEMs. Today’s market requires CMs to be strategic, with a predictive eye on both technology trends and any potential supply chain risks, while ensuring their customers’ production stays on track. Take as an example the coordination required to migrate a product from technology A to technology B (e.g. BLE to Wi-Fi), without significant regulatory impact or any product demand shortages. To do this migration or change seamlessly, a strategy must be defined and started at design.
As healthcare continues its shift to a market addressing patients, acting like consumers, with increased demands for what’s “current,” expectations are changing. In Jabil’s survey, 92 percent of respondents said that consumer demand is increasingly pushing for innovation in digital health devices.
 
Barbella: How is IoT (Internet of Things) influencing electronic component development?
Lasso: Technology is evolving at an exponential rate and impacting industries across the board. In fact, some people are now referring to the trend as simply, the Internet of Everything. The design and production of new medical devices is one of the most exciting spaces for IoT innovation. Patients are and will continue to push medical device companies to deliver products that support their connected lifestyles. We’ve seen that seamless technology integration and interoperability are key to delivering the type of predictive and preventative healthcare experiences which are increasingly becoming key to the patients’ journey to increased health and wellness. The path to this future relies on emerging technologies, like artificial intelligence (AI), communication enhancements from 5G, patient care and disease state platforms built with cloud technology, and a growing roster of Internet of Medical-Things (IoMT) devices.
Medical devices that serve within the IoMT require cross-industry collaboration and input to keep progress moving. Most importantly, these devices need to be designed so that they are interoperable within broader platforms. Without it, the potential of digital health cannot be unlocked. This effort will be a big change—and a great opportunity—if the industry is willing to adapt and accept the new challenges.
 
Barbella: How is big data influencing electronic component development?
Lasso: Big data is a major catalyst for the continued evolution of sensors, increased computing power and connectivity, as well as driving improvements in cybersecurity, miniaturization, and power management. To sustain these big data-driven improvements, all medical devices essentially need to be “triaged” for the urgency of a new design refresh.
Remote patient monitoring (RPM), as well as analytics and communications protocols, are becoming more and more prevalent in treatment plans. These serve to connect patient and provider in an invaluable feedback loop, both post and pre-op so that patients receive the right level of care at the right time. Wearable fitness monitors and other sensor-enhanced devices and clothing have ushered in a new generation of mobile health-savvy consumers, who are not only eager for engagement with health metrics tracking, but also comfortable with offering their data up to the Cloud.
All these connected devices generate a continuous stream of health data purposed for patient support, predicting, or preventing poor outcomes and otherwise harnessing perspective for greater therapy insights and improved health. They also check a significant number of boxes on the value-based care (VBC) wish list. But none of this extraordinary value in connected healthcare data can be fully leveraged without a collaborative commitment to standardize and enable secure access and availability with incentivized participation across all stakeholders: payer, provider, and patient.
 
Barbella: How is AI (artificial intelligence) influencing electronic component development?
Lasso: From a device design perspective, AI integration into healthcare is actually similar to IoT and big data, but much more difficult to implement. Today, we still expect and require physicians and clinicians to analyze and determine medical outcomes. How to leverage innovative technology to best support the decision making from these care givers still needs to be determined and will depend highly on the quality, availability, and security of patient data.
 
Barbella: How is the trend toward miniaturization of medical devices driving the design of electronic components? Please explain.
Lasso: The growth in RPM, wearable and “point-of-need” (not just point-of-care) devices is significantly influencing design options and requirements for new medical devices. These markets are being driven by desire for more functionality with increased portability and mobility. Miniaturization is one of the key solutions for product designers and engineers answering the market's call. As they push their capabilities into next generation devices, reducing form factor size and optimizing power consumption, the challenge then shifts downstream. Remember, miniaturization is a trend felt across all industries, so the impact is also significant for supply chain, sourcing, and component availability.
Here’s an exciting example of the potential for smaller form factors to improve patient experiences. A dialysis device traditionally intended for in-center use, can now be reduced in size with enhancements to both power consumption and connectivity requirements so that it performs exceptionally well in a home environment. Miniaturizations allows for better patient care at a lower overall cost.
Miniaturization is also a major catalyst in the highly rigorous clinical trials market. Smaller form factor, unobtrusive wearables with innovative sensor and connectivity enhanced designs are improving data collection and supporting much higher adherence in clinical trials. That’s a lot of technology to fit on a wristband, or connected injector, and that requires sophisticated design, component integration, and assembly.
 
Barbella: In what ways is the changing regulatory environment impacting electronic component development?
Lasso: Other industries will typically implement technology innovations into updated products at lightning speed, but the regulatory responsibilities native to healthcare force a slower pace. So, it’s not surprising to see that regulatory processes continue to be the most frequently reported challenge in the development and delivery of digital healthcare solutions. Nearly half (45 percent) of Jabil survey participants affirm being concerned or challenged with regulatory processes like FDA approvals, process certification and more.
Prior to the pandemic, regulatory bodies worldwide were addressing the challenges arising out of new healthcare solutions. In the United States, the U.S. Food and Drug Administration (FDA) pre-certification program for medical software startups has validated and encouraged a more diverse set of players into the healthcare arena, enhancing and accelerating even more constructive disruption and transformation for the industry.
In the European Union (EU), the Medical Device Regulation (MDR) will soon be replacing the Medical Device Directive (MDD) which means new definitions, classification rules and requirements. Regulatory requirements are complex, and the landscape is actively shifting, particularly in application to digital health solutions. Modular design architectures which address the "non-therapy" portion of a medical device for more timely product performance enhancements, may be an optimal approach for minimizing the complexity of regulatory approvals.
 
Barbella: The industry has grappled with a worldwide electronic components shortage in recent years. What solutions are available to tackle this problem?
Lasso: The most important solution to shortages is for low-risk and timely implementation of new technologies (electronic components) in medical devices. This is only possible if the thought and strategy has been put in place at the outset of design so that maintaining technological currency can be done with a minimum impact. What’s really required—in context of a product’s lifecycle—is the ability for designers and the product people to be both predictive and proactive in planning.
This is an incredibly important driver of success. With the right intelligence and architectural strategy, medical devices can be easily updated with new components or technology before facing major obsolescence challenges.
We’ve seen companies with highly talented designers and supply chain teams that deliver heroic work-arounds to keep a dated product in the hands of customers, but when a competitor comes along with a new product with fewer supply chain headwinds—they’ll get off the blocks much more efficiently. Being aligned with current standards of technology is like losing deadweight; it has the kind of impact that can take you from volumes of a few thousand a year to millions in six months.
 
Barbella: How does Jabil tackle electronic components shortages and parts obsolescence?
Lasso: I’ll use recent activity to describe our approach. Dependency on dated EOL technology has been quite common for a substantial number of ventilator products experiencing big upticks in demand due to COVID-19. Being first—getting requirements loaded and out to the market before others seek the same—allows you to get those very limited EOL technology resources. Jabil’s network of suppliers and our broad customer set enabled us to pre-alert suppliers of all the components that we buy from them that are directly impacting the fight against COVID-19. This was done even before we loaded and communicated the huge upsides in demand. Planning and communication have been crucial.
At the same time, we built an “exchange” creating a single site where all our distribution partners publish their inventory positions sparing our buyers requirements for sending files and making phone calls (the need for speed). Simultaneously, we reached out to Jabil customers in both the automotive and defense sectors, who immediately stepped up and began searching their inventory and their channels for the COVID-19 impact parts. Being able to share requirements quickly and easily across many entities generated immediate upside capability for the first delivery of life-saving ventilators. Carrying that a step further, we were able to take all shortages and run them through the data within our Jabil InControl supply chain platform and identify part crosses. For one product we were able to cross 19 parts with massive supply disconnects, get them qualified and purchased. This would have been unthinkable under normal conditions. In essence, healthcare, the slowest moving and conservative industry by nature, transformed into one of the fastest. And instead of people dying from lack of equipment, people’s lives were saved.
 
Barbella: Please discuss any other trends you are noticing in electronic component development (medical devices).
Lasso: Wearables for real-time continuous monitoring, cellular direct-to-cloud data transmission (i.e., eliminating the gateway), home use or point-of-need RPM devices, and data interoperability are significant trends that are being driven by the technology evolutions of IoT, AI, big data, and miniaturization. Consumerization is another big factor that must be considered when planning design and development of new medical devices. An OEM product strategy must cover these and other trends to ensure their medical products stay relevant and current throughout their lifecycle.
Jabil’s R&D team regularly builds tech demonstrators to test and showcase how we are able to embed leading-edge electronics and connectivity capabilities into devices for improved performance and utility. These include portable air quality monitors, body patches with a variety of miniaturized sensors for biometrics tracking, silicone over-molding for wearables, microfluidics for instant in-the-field testing, smart inhalers, and more. All of these capabilities feature sophisticated data collection and communications. As the consumer and their healthcare providers seek knowledge, efficiency and most importantly—better outcomes—electronics and technology have a huge role in delivering on that promise.