Left to Our Own Devices: Making Medical Technology Work is the Real Design Challenge
Remote digital healthcare for patient monitoring and digital drug delivery has been a reality for some time, but it hasn’t gained much attention outside the medical field. That is, until the COVID-19 pandemic put a spotlight on the critical challenges of our changing world.
The pandemic serves as a reminder that manufacturers of digital health devices for patient monitoring and drug delivery have been rapidly redefining medical equipment to become more patient-oriented. Designing devices that are lightweight, flexible, and easy-to-use, but which also balance patient safety and adherence is no small feat.
The inflection point: Technology defines the era
Digital healthcare and its associated devices are no longer simply a convergence of technologies that already exist but are today at an inflection point that is driving change within the evolving global marketplace. Determining the nature of that next generation of innovation in Medtech is the challenge.
Effective medical device design requires a holistic look at a patient’s specific overall needs. This must include not just medical requirements, but also financial, social, and technological needs, and it must conceive unobtrusive ways to meet those needs seamlessly and effectively.
The motivation? Clearly, the lack of adherence to a medication regime unfortunately leads to considerable, but avoidable, medical spending and accurate monitoring is the key. With up to half of all Americans not taking their medications as prescribed, an efficient patient monitoring (and digital delivery) scenario is a necessary goal. In findings from Molex’s recently released “Digital Health and the Future of Pharma” survey, 60% of respondents stated that the primary business benefit of digital drug delivery was the reduction of the overall cost of treatment through increased adherence.
The design challenge
There are, however, several obstacles that lie in the way of full adoption of a rich digital drug future, including concerns about lapses in data privacy, and challenges in usability and connectivity, plus regional and local regulatory hurdles.
While Molex has been active in medical device design for several decades through the development of user interfaces, control panels, flexible printed circuit assemblies, and disposable EKG electrode applications, the acquisition of Phillips-Medisize in 2016 has accelerated our ability to address the challenges in drug delivery and patient monitoring through wearable solutions and other platforms that enable effective data capture.
Small size, ease of use, accuracy, reliability, and battery power are all acknowledged as important design considerations for medical wearables, as well as patient comfort. For this, the use of flexible, stretchable, expandable, and durable substrates is key to a design, based on a typical patient’s usage patterns, behaviors and environments.
Components that have traditionally been mounted on rigid printed circuits boards (PCBs) are challenging medical wearables designers to integrate these same components on flexible substrates without compromising performance, efficiency and reliability. Add to this the need to design-in materials and components that are medically compatible, while also durable for longer-term performance – these hurdles are not inconsequential.
Further, the sourcing of ‘new’ materials and components also represents supply chain and compliance challenges, further exacerbated by the common requirement to design with component and manufacturing redundancies in mind. COVID-19 has effectively given rise to a new ecosystem where typical design cycles have been compressed and manufacturing redundancies have become even more important.
Medical wearables in the real world
The benefits of medical wearables are many. In surgical settings, patients may be monitored, and data collected, using peel and stick skin contact pads or sensors, without the discomfort and potential hazards of wires. One poignant example of this would be the monitoring of an infant’s heart rate, which lends itself well to a remote wireless system, avoiding the discomfort of heavy wires, limited body surface area, and potential damage to sensitive new-born skin, all which may also affect readings. In some cases, the accurate and convenient wireless monitoring of certain vitals with commensurate control can be achieved
For home patients, a trend toward preventive monitoring gives a level of convenience, efficiency and cost-saving, plus early detection through connection to the care provider. Typical health data collected as part of a patient monitoring regime may include heart rate, temperature, and blood glucose levels for diabetes patients, with data collected and transmitted wirelessly back to a base-station.
Interestingly, there are some cultural differences to consider with the remote patient medical data collection model, with some Asian countries historically more tuned in to the practicalities of measuring and monitoring health data personally. Also, some European countries have a history of embracing new technologies faster than others like the US and Canada. With changing national and international regulations however, such trends may be shifting.
Cohesive approach works best
As remote patient monitoring and digital drug delivery become more widespread, so does the need to design all key elements of the measuring and communications technologies carefully. As a case in point, measurement of patient vitals is not simply a matter of getting the hardware and mechanical elements of the measurement process refined and compliant with regulations, as it might have been in the past. Today it requires alignment of cohesive and qualified software and electronics design to ensure efficient process control, consistency, training, revision controls, and risk mitigation.
Respondents share their concerns
The Digital Health and Future of Pharma Survey indicated concerns on the part of respondents, 96% of whom reported adoption challenges. First among them is high device and connectivity costs, cited by 39% of those surveyed. Cost drivers within the electronics industry are well known, with chip design and fabrication well in the lead. Pandemic shortages, plus regional trade frictions and supply chain logistical challenges, have also been enormously challenging cost factors.
The survey results, however, revealed a common theme: making patients the top priority improves adherence and patient outcomes, while simultaneously reducing costs.
Bending the technology to meet needs
‘Connected’ digital healthcare demands communication between patients and their providers. At first glance, this may look like simply another case of a smartphone app and a connection to the cloud, but of course questions arise as to how this will be achieved, given regional and local variations in factors such as internet access; indeed, the communications platforms involved for remote patient access will impact how costs are negotiated and shared. Further, in many cases, patients may not even have a smartphone or may have inadequate patient access to the Internet – and this is a very real barrier to the efficient adoption of digital healthcare.
Technologically, this implies a need for low-cost gateway solutions, possibly embedded within the drug delivery devices themselves, and possibly for access to what some in the industry are calling the Internet of Medical Things (IoMT).
Then, of course there are the vexed questions of privacy and the security of medical data, within a medical context that may call for high-level encryption systems. The databases informed in the digital health vision detail which medications were taken by whom, at what dosage and at what date and time; who should have access to this highly personal data though? Put bluntly, it invites attack at a very sophisticated level and medical device designers need to always keep this top of mind.
In fact, 40% of respondents to the survey cited data security risks as a possible barrier to the adoption of digital healthcare, while 52% thought data privacy and security would require “external expertise”.
Moving digital healthcare into the mainstream
58% of the survey respondents believe networking and connectivity would require the input of external expertise. There are opportunities and benefits to overcoming this hurdle. Likewise, the constantly escalating integration of advanced sensing technologies prompted 42% to say that this fast-evolving field would also require external expertise. This 42% of respondents clearly sees that Medtech is at an inflection point, where the ability of ‘tech’ to deliver a digital ecosystem for healthcare demands and integrates all the possibilities of internetworking.
Medical wearable design goals are already being reached, and industry innovation in critical areas such as printed circuit processing capabilities, advanced material selection and flexible hybrid electronics (FHE) integration, are making them possible. It will be intriguing to see how the convergence of technology will meet the digital health requirements to support profound new levels of value in digital drug delivery and healthcare overall.