The emergence of wireless technology is transforming many conventions within healthcare. More information is being made available, in new ways and in larger volumes, to increasing numbers of people in a greater number of places than ever before. While this trend offers exciting potential, its impact on current practices and standards can be startling. As with most innovations, the promise of wireless convergence can bring with it unintended consequences and new issues to consider. For medical device manufacturers trying to harness the power of convergence, properly accounting for this disruptive impact on current business practices is critical to their success. Failure to do so means failure in the market.

A Framework for Opportunity
Device company executives must consider a number of variables in determining the best way to leverage the convergence of wireless technology and healthcare services. Organizations typically have a strategy in place for vetting these opportunities and understanding associated risks. One common framework uses four criteria to evaluate both opportunity and development strategy. These four criteria are business case, technology, user, and sustainability.

Although this is an effective framework for encouraging a holistic approach to harnessing convergence, it nonetheless masks a great deal of complexity within each of the four perspectives. Historically, user- and sustainability-based perspectives did not factor into opportunity assessment as much as the technology and business case perspectives did. The vetting process was simpler but more prone to failure, as opportunities might be pursued that held little actual value for customers or devices were developed with unforeseen flaws that inhibited market adoption. Regulatory requirements and more sophisticated marketing strategies have changed this approach and in the process have made the ability to harness convergence increasingly complicated. The question then becomes: How can medical device executives consider each of the four criteria in order to make good decisions with the least amount of risk?

One strategy for making this process more manageable is to realize that although business, technology, user, and sustainability considerations each carry equal weight, they can be addressed in a logical sequence. This strategy suggests that user-based considerations can take the lead during early stages of opportunity assessment and development when companies consider the role wireless might play in medical device development. Taking this approach allows device company executives to determine whether an innovation is relevant to users, and if not, whether or not it can be modified to become relevant. Companies can still factor in the other three criteria with these user perspectives. However, in this strategy these factors will not necessarily carry the same weight as the user-based criterion. This approach mitigates the risk of using of resources, capital, and time on initiatives that have little or no relevance to the device market.

Adopting this user-focused strategy also enables device companies to effectively assess the risks of innovation by investigating the roles business case, technology, and sustainability issues play in the early stage of product development. A better understanding of users, their needs, and their goals can better direct investigations into wireless platforms, service providers, data rates, antenna design, and a host of other variables associated with harnessing convergence for the healthcare industry.

Defining User-Based Considerations
There is good news for device executives investigating user-based criteria to examine early stage opportunities and product development: These efforts require a moderately low investment relative to the millions of dollars and years of work to develop, tool/code, validate, and launch a product. Although these efforts can vary in scope, this approach can sometimes be conducted in as quickly as a couple of months. In addition, it typically costs well under seven figures.

Early stage use-based investigation involves research and analysis techniques specifically aimed at uncovering a customer’s needs, challenges, habits, and expectations. Research plans can leverage dozens of established methodologies, ranging from traditional VOC activities to applied ethnography. Although no one research plan is exactly the same as another, there are several overarching principles that medical device companies should embrace:

Be liberal in defining customer stakeholders. A perfect real-life example of this advice involved a major medical device manufacturer in the early stage of developing a remote monitoring system for cardiac device patients. A critical component of planning user-based investigations required specifying exactly who would be talking on the monitoring system. Remote monitoring fully embraces the convergence of wireless and healthcare in two important capacities, the first one being the wireless transmission of data from implant to reader and the second involving data sent from reader to clinician.

Existing remote monitoring solutions differed from each other in whether or not they supported live voice between caregiver and patient during remote transactions. Although live voice was well suited to ensure reliable data transmission, it also impacted practice efficiency and complicated scheduling because it required a dedicated clinical resource. Naturally, it made sense to involve those individuals (nurse and patient) who are directly involved in the remote monitoring process. Although these two sources were able to provide a wealth of information regarding ways to optimize the remote transaction sequence, limiting the investigation to only these customers would inhibit the team from understanding a host of other considerations.

A great deal was also learned by engaging customer stakeholders that might not immediately appear to be as relevant. For instance, because the team included discussions with nurse managers, it gained an understanding of ways in which remote transactions increased the processing workload for nurse clinicians when unexpected transmissions—for which the clinic was liable—were received from patients. Practice managers called attention to impending shifts in how remote transactions are reimbursed by payers—with technical fees (for processing information transactions) slated for reduction—and how the next-generation monitoring system should somehow account for this. Third-party vendors that provide outsourced services for this technical processing shed light on the need to optimize the system for high-volume batch processing. Without including these wide-ranging perspectives in the development effort, the development team ran the risk of designing a system optimized for nurses and patients but not for practice productivity and profitability. Understanding the complete range of challenges enabled the team to make informed decisions on key system features. These features allowed for remote transactions that did not require a live caregiver, enabled clinics to customize how they receive alerts and unscheduled transmissions, and automated the integration of collected data with EMRs.

Understand issues and requirements. Documenting customer issues helps drive product requirements, but without fully understanding the issues, requirements risk being incomplete and prone to misinterpretation, leading to solutions that fall short in the market. Many common VOC tools excel in documenting issues but often fail to provide fully actionable information to guide their resolution. For this reason, many research plans should strive to include iterative components of stakeholder involvement, where they can be directly engaged and observed in their environments.

Understanding these issues enabled the development team for the cardiac device patient remote monitoring system to determine whether or not it needed to support live voice at all. Although it would be a market differentiator, this feature utilized expensive technology and, in clinical deployment, required a dedicated resource in order to conduct remote transactions. Engaging patients and healthcare providers in their workplace environments provided two benefits. It allowed the team to gain further insight into critical elements of the remote transaction sequence and to identify possible alternatives to support these elements independent of a real-time voice feature.

Using this information, the team then developing soft prototypes for some of these new solutions returned to the field to engage customers once again. Presenting these results to users gave the team an early edge in understanding which ideas could be successful. It also gave the team valuable input in how the ideas could be further improved before too much time, money, and effort were invested in any single approach. Through this process, the development team identified means for eliminating live voice as a requirement for the eventual system by vetting the idea of automated voice and other feedback mechanisms, thus satisfying patient concerns and freeing clinical resources to work with greater efficiency.

Involve internal stakeholders. Too often, the results of research arrive in the form requirements that development and commercialization teams need to meet but may not fully understand, or even believe in. Instead, development processes should strive to leverage internal resources to shape the effort and contribute to it. Involving internal stakeholders in early stage use-based investigations yields a number of different benefits that enable device manufacturers to better understand how best to leverage the convergence of wireless technology and healthcare solutions.

Soliciting the input of key internal stakeholders while preparing a research plan ensures that the topics covered will yield better information that, in turn, can be used to provide better results. Involving stakeholders in the actual research effort gives them firsthand exposure to the people, environments, and circumstances that are integral to finding the best solution. This intimate understanding of issues fosters greater creativity in generating innovative products. In addition, this workplace knowledge can accelerate the development process by creating a continuous feedback loop for modifying the research plan in real time in order to make the best use of convergence opportunities.

During the development of the remote monitoring system described above, an examination of patient lifestyles led to an understanding of how different technology options might be leveraged for the wireless receiver. Close, real-time involvement of antenna engineers enabled the team to understand how to successfully balance a variety of considerations—from where a patient preferred to position the receiver to providing sufficient real estate for the antenna to function reliably. In the process, the team was able to confidently eliminate options that inherently carried greater reliability and cost risks without sacrificing performance or the safety of the patient and clinician.

Small Investment, Big Reward
User-based investigations provide medical device manufacturers with an expedient and informative means of better understanding how best to leverage the exciting potential of the convergence of wireless technology and healthcare. These are often relatively low investment approaches that can help a device manufacturer effectively navigate the complexity presented by this trend. Effectively leveraging user- based inputs provides a strategic means for focusing investigations into technology, business case, and sustainability issues that are better aligned with the needs of customers and the marketplace. The result is an approach that gives an organization an advantage in appropriately harnessing convergence to inspire innovation in a way that mitigates risk and ensures market success.
 

Ed Geiselhart is director of product development and planning for Insight Product Development (Chicago). He can be reached at egeiselhart@insightpd.com.