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To connect, or not to connect?

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The advantages of a connected device can be explored through the different categories of needs, by trialling a range of solutions and considering a framework of manageable steps.

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To connect, or not to connect?

  1. 1. 38 Connected Devices November 2018 Charlotte Harris, Tom Etheridge, and Paul Greenhalgh at Team Consulting The advantages of a connected device can be explored through the different categories of needs, by trialling a range of solutions and considering a framework of manageable steps To Connect,or Not to Connect? Billions of dollars are wasted each year due to healthcare solutions noncompliance. With the challenges healthcare budgets face (an ageing population and an increasing number of chronic conditions to name a few), how can patients better manage their health? While making a device connected is not a magic bullet to improve compliance and health, they present some clear benefits. How does one decide if a device should be smart, connected, or neither? Clear questions must be asked before deciding if a device should be connected or not. The categories of needs which define this include: engagement, competence, onboarding, re-onboarding, and more. These should be identified by exploring both connected and non-connected solutions, after which, the solutions to whether a product is connected or not becomes clearer. In the regulated world of healthcare, the true cost of a connected solution is high and not just financially. Patient attitudes around sharing their health data must be considered, and the benefits they receive should be worthwhile for providing that information. Understanding the Problem Many stakeholders are involved in delivering and managing a patient’s therapy. These range from the patient, the caregivers, and healthcare professionals who deliver the care, through to the pharmacist who dispenses the therapy, the payer who funds it, and, not forgetting, the pharmaceutical company that developed it. Each of these stakeholders has different needs and desires, which may or may not be satisfied through the use of a connected medical device. For example, a pharma company may want to ensure that their clinical trials run smoothly so that the therapy is successful, effective, and meets the needs of the regulators. Healthcare professionals want better clinical outcomes for patients, and, ultimately, the patient wants to have their therapy funded and to be able to manage their condition successfully. Considering these stakeholder needs, why might a connected device be helpful? What are the drivers and where are the opportunities for ‘going connected’? A connected device could be helpful in monitoring adherence, learning about patient behaviour, or helping patients engage with their therapy – all of which are linked to attaining better clinical outcomes (see Figure 1a). In contrast to this, several barriers are met when ‘going connected’, including high costs, lengthy development time, and the unwillingness of some patients to share their data (see Figure 1b). With all of these factors to consider, how can it be decided whether a connected device is right or not, and where is the real value in developing one? Necessitating Connected Devices ‘Connected’is a term that is used freely in the industry these days, but what is meant by a connected device? When identifying solutions to stakeholder needs, they could be thought of as being classified into three categories: • Dumb – These are solutions that do not incorporate any sensing or communication functionality into the medical device itself. The system may still allow one- or two-way communication with the patient (ie, through email, text prompts, and advice) but the device itself is‘dumb’ • Smart – These solutions incorporate sensing functionality into the device, but the data from these sensors remains on the device and is visible only to the user. For example, sensing functionality may be embedded within the device to monitor certain interactions. This might be teamed with visual, audible, and haptic feedback, perhaps including a simple on-board liquid crystal display to record events and provide feedback. The key to this category of solution is that this information is not shared any further Possible opportunities Competence Communicate therapy benefits Diagnostics of disease progression Disease self- management Competitor differentiation Learning about patient behaviour Patient engagement Clinical trial support Adherence support Figure 1a: Reasons for a connected device
  2. 2. www.samedanltd.com 39 • Connected – These solutions incorporate sensing and communications functionality into the device. Data is logged or transferred in real time to the Cloud (normally incorporating connectivity with a smartphone app) and the data is visible to anyone with permission and the means to access it (healthcare provider, payer, pharma company, etc) Ultimately, the ideal solution to a stakeholder need may be in any one of these categories, or it could be a combination of solutions from each of them. Exploring solutions across all categories and weighing them up against the reasons for and against a connected device will help identify whether ‘going connected’is indeed the optimum solution or whether the needs could be addressed just as effectively with a simpler solution. Matching Solutions to Needs Broadly speaking, needs can be categorised into five key themes: • Competence: the ability to complete the task correctly • Adherence: compliance with specified medication regimen • Engagement: actively encouraging use • Differentiation: standing out from the competition • Clinical trial support: confidence in clinical results and the three previously mentioned classifications of solution with which to address them To see whether a connected solution is, indeed, the optimal solution, the opportunity space can be mapped and ideas for solutions explored in Competence Dumb Smart Connected Figure 2: Opportunity space map Competence Technical complexity and risk Potential increase in device size Negative patient attitudes to sharing data Potential wastefulness High cost and long development time Increased BOM/unit price Could add burden to user Potential barriers against a connected solution Figure 1b: Reasons against a connected device
  3. 3. each square of the map (see Figure 2, page 39). By assessing each idea against how well they meet the need and weighing this up against the technical and commercial implications of implementing it, making a judgement on the advantages of going connected is possible. For example, if the need for competence in device use is looked at, a possible‘dumb’solution could be to redesign the packaging and information so that it clearly steps the user through the use of the device. Similarly, if the need for engagement is looked at, an indicator on the device to show when it was last used could be a smart way of providing the information needed to better engage a user. With the need for adherence support, a fully connected solution which takes data from the device and transmits this to the Cloud for the HCP to view could help. Any of these solutions could be viable, and the most suitable will depend heavily on attitude to risk, technical, and commercial constraints, and, ultimately, the likely financial cost or savings that could be achieved by a connected solution. Certainly, in the case of improving competence, a well-thought- out piece of packaging and information design could go a long way towards guiding the patient through using the device without the lengthy outlay and risk involved in developing a connected solution. However, when monitoring adherence, a smart or connected solution might be more appropriate. Taking a Punt If it has been decided that a connected solution is the best way to meet the identified needs, the next challenge is to prototype and test it. Deciding what to sense is key: ‘just because you can, does not mean you should’. While adding clever technology is a good way of ensuring a device has maximum sensing potential, it also runs the risk of generating needless data and increasing power budgets, size, and device cost. The time to develop a quick and dirty prototype has been significantly reduced thanks to the array of readily available development boards, such as those by Nordic Semiconductor, ST Microelectronics,Texas Instruments, or Diolan, to name but a few (see Figure 3). For just a few dollars, these boards can measure multiple parameters, such as sound, temperature, orientation, acceleration, and humidity, etc.They come paired with a communication module that allows data transfer to accompanying software.With such boards, creating and testing the technical feasibility of early concepts, without having to embark on a lengthy development path, is easy. However, the most important thing that early prototyping provides is the ability to test concepts with people.This allows for 40 www.samedanltd.com Image:©TeamConsulting Figure 3: Off-the-shelf development boards
  4. 4. About the authors Charlotte Harris is a Senior Consultant at Team Consulting whose work typically focusses on managing the strategic and creative ‘front-end’ of the product development process. She has over 20 years’ experience in the medical device industry and has worked in clinical, start-up, and consultancy environments. Charlotte studied medical engineering and has a BEng from Cardiff University, UK, and an MSc from Kings College London, UK. Email: charlotte.harris@team- consulting.com Tom Etheridge is an Industrial Design Consultant at Team Consulting who uses his experience to deliver holistic support to design, engineering, and human factors groups. He has a degree in industrial design technology from Brunel University, UK, and has worked in a design consultancy environment since graduating in 2010. Tom has been the lead industrial designer on several projects ranging from medical devices to consumer electronics. Email: tom.etheridge@team- consulting.com Paul Greenhalgh heads Team Consulting’s design group. He is a passionate advocate of the importance of ‘good design’ and is involved in all stages of product development, from front-end innovation to detailed design for manufacture. Email: paul.greenhalgh@team- consulting.com carrot or stick that encourages adoption? That question can be answered once a larger number of connected devices are on the market that deliver real and holistic benefit to patients, payers, prescribers, and manufacturers. www.samedanltd.com 41 stakeholder input at an early stage and the option to assess which features are useful and will add most value. Getting this information early on in the process is key to informing the design and feature set of the device. Not only does the connected solution have to address a need, but its implementation will be key to getting users to engage with it (as well as its ultimate success). The Human Factor The importance of motivating the user cannot be ignored.What will make them engage with the system?Without that motivation, even the‘smartest’solution may fail.This is where something may be learnt from the consumer world.Think about the many apps that essentially do the same thing – what makes one of them the blockbuster? Often, it is not about the amount of functionality in the app – it is more about its implementation and usefulness: the way it provides the service you want, and how digestible it makes the information. In this instance, less is often more.The design of the user experience (UX) will be key, as following a user-centric development approach will be essential to understand what details or nuances engage users to help them onboard and stay with this new technology. The users of these connected solutions are likely being asked to give up a certain amount of privacy and control, so, understandably, they will feel they need something in return – and feeling‘better’ might not be enough. Leaving the huge topic of payment by results to one side, how the systems provided get the balance right between user input and useful output (for the user) needs to be considered.What can make it instantly easier for the user to manage their condition? Is it reminders, access to additional information and support, or something else? All of this might be possible if smartphone connectivity had already been introduced into the system.This is particularly important if the connected element is an add-on to the device rather than integrated, where the user is asked to do an extra job in addition to what they are used to. In summary, it is a complex question (and unlikely to be a‘no-brainer’to go connected for some time yet). However, the opportunities a connected system offers may reach way beyond the practical issues of sensing and confirming correct use.This article presents some ways of breaking down the question into more manageable chunks, which should help to assess the full breadth of opportunities. Creating early, low-cost mock-ups to gain user input on the effectiveness of an idea is important, so that solutions are introduced that meet a real need and the importance that UX design will likely play in achieving success is highlighted. However, maybe the only way to truly answer the question is to ask how confident one is feeling. While most of the big players in the industry are currently tooling up for this brave new world, it is still too early to be able understand how consumers will react.Will it be

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