Device makers are used to designing to meet patients’ medical needs, but considering their nonmedical needs as consumers is increasingly important.
The need to drastically reduce healthcare costs and improve outcomes is focusing attention on the importance of patient engagement. The doctor-knows-best mindset is quickly fading, as people are no longer content to be back-seat patients and are instead demanding insight into their healthcare and the medical devices they use.
|A smartphone-based diagnostic reader app developed by Cambridge Consultants uses the phone’s camera to optically read a lateral-flow assay or color-based diagnostic strip, coupling medical device prowess with consumer-loved technology.|
Medical device companies used to selling their products to hospitals and physicians are increasingly finding that patients are their new customers. Device makers must appeal to this new market, which is used to the fast-pace and innovative technology more akin to the consumer electronics industry. A consumer who selects her smartphone based on its interface is likely to want to do the same with her insulin pump, for example.
The challenge to move toward consumer-orientated developments is three-fold: stringent regulations often dictate many aspects of medical developments, technologies used in medical devices traditionally focusing on creating optimal functionality with little thought for user-experience, and medical devices take much longer than consumer electronics to bring to market. To appeal to the patient-consumer, device makers should consider gaining patient-consumer buy-in through the parallel development of nonregulated wellness products, embrace technologies that are commonplace in the electronic consumer goods market, and step up the pace of innovation.
Some device makers are bringing products to market faster by positioning them not as medical devices but as wellness devices, which blur the line between healthcare and consumer applications and sit outside the realm of medical regulations.
Initially, it may feel unintuitive for medical device companies to develop nonmedical products. However, once core technologies and competencies are identified, adjacent product offerings with reduced or alternative functionality could be launched into the wellness or disease management market using the same expertise. For example, Philips Healthcare has launched an activity monitor, DirectLife aimed at helping users lose weight and get in shape. The device builds the company’s brand awareness among consumers, but it is not a regulated device.
Consumer-facing wellness offerings enable companies to expand their clinical brands into the nonregulated space. As consumer choice becomes prevalent in the medical sector, wider brand recognition can be an advantage. Furthermore, wellness devices spun off of medical devices can result in new lines of revenue in a rapidly growing market.
In both the United States and Europe, the applicability of medical device regulations is based on the primary purpose of the device. Similar devices sitting on the consumer-medical border may be regulated differently only because of their marketed uses. For example, a device that monitors heart rate is considered a medical device when marketed as an ambulatory cardiac monitor but is classified a consumer product when marketed as a fitness device, such as those from Nike or Garmin.
The decision to position a product as a wellness device should not be made lightly. Companies must find the correct balance between desired functionality, the limits of devices sitting outside of regulation, and the burden of regulatory approvals. They must identify the boundaries of regulation and determine which features or functions turn a product into a medical device. Technical expertise, coupled with long-standing healthcare insight, will provide medical device companies with a good foundation from which to expand their product offerings. Lessons can be taken from the consumer space to provide valuable insight into areas such as usability and consumer preferences, which will, in turn, benefit core medical product developments.
To appeal to the patient-consumer, medical devices must go beyond simply functioning and ensure a good fit across patients’ medical needs as well as their nonmedical needs as consumers. The end-user and market needs must be considered in the design phase, as usability and intuitiveness of the interface are likely to drive uptake of a device as much as its core functionality. Considerable work has been done to this end in the consumer electronics market, and medical device companies could benefit from embracing existing technologies that are already consumer favorites.
For example, the proliferation of smartphones has positioned these devices as pivotal instruments in healthcare. They are without a doubt becoming the preferred tool for health management. A recent survey of U.S. physicians reported 33% communicate with consumers using e-mail and/or text messaging, and 26% direct consumers to online healthcare content.1 Additionally, 86% of clinicians surveyed use smartphones in their professional activities, and 53% use tablets. A direct consequence of this preference can be seen in the launch of iPad and iPhone versions of most major EMR solutions in the past year.
Other consumer electronics technologies such as Bluetooth chipsets can also shorten development timelines for medical devices requiring wireless communication capability. Device makers can get to market quicker by deploying these readily available technology blocks rather than developing custom protocols, as is evident in the launch of the Verio glucose meter by Lifescan, which communicates with iPhones, iPads, and other mobile devices via Bluetooth.
However, care should be taken when using off-the-shelf solutions, bearing in mind the critical dependencies, risks, and failure modes. For example, the wireless technology used in a device affects not only the cost but also the user experience and business model of the device. Choosing the wrong technology (e.g., one the market fails to adopt) may lead to expensive infrastructure requirements and limit product success. Device makers must make informed choices and intelligent architectural decisions to allow flexibility and limit dependency on a specific hardware version of off-the-shelf platforms.
The patient-consumer influence in healthcare is growing, and medical device companies must adapt. To appeal, device makers must take a page from the consumer technology industry’s playbook and increase the pace of innovation when it comes to their patient-facing products.
Start-ups are already doing this, and they by far dominate the market for mobile medical devices and apps. Start-ups tend to think outside the box and have the ability to move fast, often bringing products to market in a shorter time frame compared with larger established device companies. Take MIM Software, for example. In February 2011, this company was among the first to obtain FDA approval for medical imaging software on mobile devices, allowing doctors to review CT images on an iPad.
To avoid losing market share, larger companies must respond by streamlining their product development cycles for patient-consumer products, increasing pace without increasing risk. Decision-making capabilities are fundamental to enable a satisfactory development pace. Smarter partitioning is also important—selecting, for example, which elements of a solution can be launched first and which require longer development times.
Mobile apps provide the perfect stepping stone for medical device companies looking to embrace the patient-consumer market. Apps can be developed within or outside of medical regulation, they are well-established and popular in the consumer market, and they are suited to a rapid development process.
People today share their lives online and have instant access to information via any number of gadgets. As a result, patients now expect a similar experience when it comes to medical technology. Device makers are meeting that demand with mobile medical apps. The vast number of medical apps on the market today is indicative of the consumerization of medical technology, and the rapid rate at which these apps are being created demonstrates the fast pace of development needed to satisfy today’s patients.
Medical device guidelines are well established, but this is not yet the case for regulation of mobile medical apps. In July 2011, FDA drafted guidelines summarizing its foreseen approach for the regulation of mobile medical apps. Two years on, this draft document has yet to be finalized. While FDA and similar regulatory bodies decide how to safely manage medical apps without killing innovation, device makers must remain up to date on where the lines are being drawn and develop a flexible approach to their app development processes.
FDA has also offered companies help in navigating this uncertain space. Device makers would greatly benefit from establishing a designated role for liaising with FDA on mobile apps. Determining classification early, and therefore having clarity of requirements for approval, will enable better design of apps and less rework in the longer term. It is anticipated that regulatory bodies will progress to examine systems as a whole, including IT infrastructure, and no longer consider only the stand-alone device when considering approval. In fact, standalone medical devices are likely to be a thing of the past as connectivity becomes ubiquitous and data sharing becomes mandatory, making expertise in this area increasingly important.
Currently, medical apps are approved on a given platform, working with a defined mobile device. Developers would benefit from a building-block approach, allowing modules within any system to develop independently. Smarter partitioning of software functionality between the medical device, the mobile app, and the backend server can help to manage regulatory classification and the burden of verification and validation. This offers an opportunity for medical devices to continuously be improved and mirror the fast pace of the consumer market.
The capability of an app can also be extended via the addition of hardware or sensors, either attached to or part of the smartphone. For example, Alivecor has launched an approved ECG app that uses two electrodes attached to an iPhone to gather data. By applying knowledge of human factors and improving usability, developers can increase the appeal of their apps considerably with little change to the underlying technology. Apps can also be customized to provide different interfaces or add-ons tailored to varying consumer groups, ideal for developing adjacent product offerings in both the medical and the wellness or disease management markets.
Consumer influence will continue to grow in healthcare. Successful companies will be those that can quickly and effectively leverage key elements of both the medical and consumer industries. Ultimately, companies with a consumer focus and dynamic development process alongside well-established medical device regulatory know-how are set to do well. Those companies, of which there are many, that fall short in one area should look to collaboration and partnering as routes to market. A building-block approach to development, allowing different parts of the system to develop separately, accommodating regulatory requirements, while maintaining a dynamic and upgradable design, is likely to enable success. Employing strategies such as positioning products both within and outside of medical regulations, leveraging appropriate off-the-shelf solutions, and embracing emerging trends such as mobile apps will enable device makers to thrive. Those that can’t keep pace will be left behind.
1. Maximizing Multi-Screen Engagement Among Clinicians, [online] (San Mateo, CA: Epocrates Inc., 2013; available from Internet: www.epocrates.com/oldsite/statistics/2013%20Epocrates%20Mobile%20Trends%20Report_FINAL.pdf.
Anna Cuthbert is a senior analyst within the Medical Technology Consulting Group at Cambridge Consultants. She works across a range of medical device and pharmaceutical projects specializing in the development of bespoke product development and program management frameworks. Cuthbert also provides expertise in areas such as the evaluation of candidate medical technologies, user and expert insight interview programs, and market and company assessments. She holds a PhD in nutritional epidemiology from the University of Cambridge. Reach her at email@example.com.
Vaishali Kamat heads the Digital Health practice at Cambridge Consultants. She has significant domain expertise in this new and evolving space, including an understanding of regulations, financial models, and market players. She has worked with several large medical device and pharmaceutical companies, helping them define patient facing solutions and incorporate connectivity into medical devices. Kamat received a Master’s degree in electrical and computer engineering from Iowa State University and has been named as inventor on three U.S. patents.