Part 4 of a 5 Part Blog Series on | "Advancing Public Health with Wearables; Strategic Development of IoMT Biosensing Lifestyle Devices"

Although not entirely new to the market, IoMT biosensing lifestyle devices remain a relatively recent development in the medical device realm, with a commercialization process not nearly as well defined as other medical device types. As these devices continue to grow in popularity, with technology and applications expanding rapidly, navigating their development can be uncertain even for the most experienced device companies.

MIDI’s DevelopmentDNA™ methodology utilizes a pre planned Innovation Roadmap™ to streamline development and guide clients towards producing an innovative, commercially successful device that meets all necessary regulatory controls. Three stops exist on the map: Stop 1, market exploration and discovering opportunities; Stop 2, technology innovation and the R&D process; and Stop 3, commercialization and implementation. As development continues along this template, all FDA QSR and ISO 13485 recommendations are met and followed. The FDA’s prescribed development method is appropriately applied and documented within MIDI’s Quality Management System (QMS), pointing to various standard operating procedures or SOPs. Here, we discuss Stop 1 and 2 as they apply to IoMT biosensing lifestyle devices.

Stop 1: Market Exploration and Discovering Opportunities

Discussing Stop 1 on the Innovation Roadmap™ requires defining what innovation looks like in a wearable device. An innovative IoMT wearable device can be defined as having four key characteristics; the first is satisfying a specific market or user need. This may come in the form of a first-of-a-kind product fulfilling an unmet need or an optimized product that helps an existing need to a higher degree. Second, the device must be reproducible at an economical cost readily accepted by the market. Third, it should be effective in all aspects, including functional performance and ease of use. Fourth and finally, it must be safe for both the user and the larger public.

Of these characteristics, Stop 1 concerns itself with the first two characteristics in particular. This step is all about defining and establishing a value proposition between the device and its external stakeholders, including doctors, patients, purchasing decision-makers, insurance reimbursement, et cetera. The key to doing so is discerning what needs of the latter can be met by the former. In contrast, they do so at a cost agreeable to the market and profitable for their business. A value proposition such as this consists of two components: external stakeholder needs and internal stakeholder needs.

The primary guide of a device’s design, identifying external needs is the entry point of this process and is often a significant catalyst of innovation and competitive differentiation. MIDI utilizes several methods to complete this task, one such being target market identification, in which markets are examined and weighed against corporate goals to be ranked and prioritized, while the stakeholders within these markets are identified, including those as far along as associated gatekeepers who make decisions regarding purchasing and insurance reimbursement. With stakeholders identified, VOC or Voice of the Customer studies may then be deployed in the field to observe care environments, discern current clinical needs, and explore any prospective unmet needs, after which user interaction analysis can be performed to distinguish unspoken needs further. Workflow analysis and task mapping are essential tools for gathering external requirements as well, the key to establishing stakeholder workflow and what their pre-, during, and post-use rituals may be.

Internal stakeholder needs include all those from a business perspective that will allow the company to pursue an innovative direction capable of yielding a profit and a defensible position in the market through strategic differentiation. One tool used to pinpoint these needs is competitive market analysis, ranking and rating existing device solutions to identify unexplored market opportunities and insufficiently met clinical needs. SWOT analysis is another tool in which company strengths, weaknesses, opportunities, and threats are weighed against the competition to help form the call to action that will lead the ideal go-to-market path trajectory.

Important to mention that FDA QSR and ISO 13485 guidance clarifies that regulatory controls such as design controls and risk management need not be performed at this point, recognizing the necessity of first exploring opportunities for success. The FDA consistently looks to encourage the creation of safe medical devices without hindering innovation or business; yet, Stop 1 does serve an underlying purpose in achieving that goal. Farther along the map, we shall see properties and information collected during early, unconstrained processes act as the framework informing design controls and risk management processes which must be implemented during the development process at Stop 3. The requirements identified here will also assist the development team in staying on track during design.

Stop 2: Technology Innovation and the R&D Process

With the data at Stop 1 collected and analyzed, a market requirement document or MRD is generated to inform the next stage: technology innovation and the R&D process at Stop 2. Like the first stop, the FDA excludes this second stop from regulatory control requirements, recognizing the exploration of development opportunities, methodologies, and technologies performed here as quintessential to success.

As a step revolving around solidifying the specific attributes of a device, many tools might be employed during the processes of Stop 2. DiscoveryResearch™, MIDI’s methodology known as their engine for identifying, collecting, and qualifying the challenges, technological vectors, influencing agents, and relevant facets for medical device success, is one such tool that allows the team to ascertain project development and technology parameters better, as well as further discern user needs in their environment. Particularly when developing IoMT wearables, defining user needs and environment is a crucial Stop 2 activity. For any wearable medical device to be successful, it must have a proper user product experience and well-planned human-machine interface, which encourage correct usage and compliance while promoting meaningful product-lifestyle relationships and positive experiences.

Focusing on technology, MIDI’s goal for Stop 2 is to generate sustainable value, IP protection, device efficacy, and profitability overall while identifying opportunities to achieve such for all client programs. To this end, a Systems Analysis™ is performed, and an associated report is created utilizing all previously collected information that defines the proper means of formulating, prioritizing, and documenting all R&D data, yielding a highly detailed understanding of client marketing, design, and engineering requirements. Through this, research and discoveries may be oriented in a targeted direction leading to particular innovations in the IoMT wearable field.

With R&D directives in place, iterative exploratory device conceptualization is paired with technology research to allow MIDI to generate and fabricate breadboard concepts, which are then subjected to internal testing. Additionally, external usage studies test human-machine interface quality. Repeating this process in an AGILE format will establish a quality feedback loop of breadboard refinement that will eventually result in multiple iterations to be documented in preparation for commercialization at Stop 3.

Sensor Selections, Applications, and Advancements

An integral part of IoMT wearable development, which distinguishes it from the development of other medical devices, is how the functionality of the device itself is deeply tied with that of the sensor technology used within it. Choosing a sensor modality is a matter of narrowing down choices based on user and time-related needs and should be done in collaboration with a strong sensor supplier with relevant experience. MIDI often teams with Valencell, a biometric sensor technology company focusing on PPG or photoplethysmography sensors in downselecting sensor components. PPG sensors are widely used within IoMT wearables, with a highly recognizable example being the green blinking lights typically featured on the back of a smartwatch or fitness band. These sensors shine light into the body and utilize reflected light measurements to read several biometric signals; At the same time, the most common of these is heart rate. MIDI and Valencell have also deployed them in quantifying heart rate variability, cardiac efficiency, pulse oxygenation, blood oxygenation, and, most recently, blood pressure.

As with nearly every step of device development, selecting the sensor technology for a wearable device is a matter of, in the words of Valencell Vice President Ryan Kraudel, “starting with the end in mind.” Using the desired patient outcome as a launching point, one must determine what assessments will be necessary to achieve that outcome and what biometric measurements those assessments will require. These metrics will primarily dictate what sensor technology may be used in the device, although form factor and user experience each play a significant role.

Today, biometric sensors and sensor systems like those developed by MIDI are advancing, improving, and widening their capabilities more rapidly than ever. Where the first generation of IoMT wearable devices, those such as early Fitbit trackers, utilized accelerometry based sensors to measure step counts and overall activity levels, the second generation moved essentially to PPG sensors, which offer more comprehensive insights into health and activity both at the time of measurement as well as over more extended periods. With the third generation of IoMT wearables beginning, these sensors are increasingly paired with medical expertise, installed within regulatory-controlled devices intended to treat or assist in addressing specific medical conditions, and often utilized alongside existing pharmacotherapies or other therapies therapeutic approaches. Particularly, PPG sensors are seeing broad adoption in the realm of cardiovascular monitoring, as well as in the management of respiratory conditions, diabetes, and hypertension.

Despite its importance, blood pressure monitoring and management is a field that has seen little advancement since the introduction of the inflatable cuff in 1911 and is poised to gain much from the integration of PPG sensors, with cuffless, calibration-free technologies now being brought to market that will allow for continuous passive blood pressure monitoring for patients in their daily lives. Overall, this follows the macro-level trend currently seen in the medical device arena. Healthcare is increasingly demanded through remote means, with care being delivered outside of medical facilities primarily through digital monitoring and therapeutics. It also aligns with a shift presently taking place in which fee-for-service payer models are now being pushed out in favor of value-based care, placing a more considerable emphasis on prevention and early detection, both of which require regular monitoring to pursue. And PPG sensors still stand to make a difference in healthcare facilities.

As sensor technology continues to improve, consumer wearables are becoming more like personal health and even outright medical devices each day— one look at recent releases from Apple, Fitbit, Samsung, Google, or Garmin can illustrate the interest currently being taken in integrating healthcare into daily life. This shows that there is an entire realm of unmet medical needs outside the realms of hospitals and doctors’ offices, with a booming industry rising to meet them.

Follow along in the next blog to find out more about how MIDI can help you bring your IoMT wearable to market at Stop 3 of the Innovation Roadmap™, commercialization and implementation.