The Perils and Potential of Connected Medical Devices
With the potential to improve patient care by providing personalised treatment, the trend to add connectivity to devices and services within the medical sector shows no sign of slowing down. Recent reports suggest the current global wearable healthcare market is estimated to be $0.9billion and is expected to increase to $17.8billion by 2021.
The growing range of ‘devices’ includes: consumer health wearables, remote access to GP’s, physiological monitors such as ECG trackers, and apps to monitor adherence to medication. But the key question remains; are they really improving patient care and consumer health?
The Importance of Usability, Safety and Security
Just because a device is connected, doesn’t mean that it’s automatically going to be useful, or even desirable. A quick glance at the @internetofshit twitter account is enough to dampen the most fervoured of IoT-enthusiasts connected fever-dreams. It’s easy to laugh at gimmicks that don’t really deliver anything beyond a live-data-widget or extreme-convenience; such as connected kettle that allows you to start a boil from your phone hundreds of miles away. However, in the world of medical devices, when a connected device that does more harm than good can risk the health or life of its user, it’s clear that IoT in healthcare requires serious thought given to user safety as well as experience.
The desire for fantastic, friction-and frustration-free experiences should not foreshadow our consideration of safety and security issues. ‘Move fast and break things’ is not a phrase that inspires confidence in medical. The FDA recalling 500,000 internet-connected pacemakers manufactured by Abbott Health* over hacking fears highlights the need to consider all aspects of these products during the design cycle. When a project starts with a genuine, well thought-through use case that considers privacy and safety as holistic parts of great user experience, is when products gain sustainable traction.
Cost and Simplicity
A key factor to the commercial success of connected devices is of course delivering functionality which adds real value at a price point which enables broad market appeal. The increasing adoption of smartphones and companion devices in the consumer space has driven down the cost of implementing technologies such as Wi-fi and Bluetooth to the point that for many products, connectivity no longer represents a significant proportion of the device cost.
Furthermore, with high end smartphone BOM costs continue to rise, driven primarily by displays and processors , devices like Medtronic’s Guardian Connect System* are seizing the opportunity to reduce device size and cost by ditching the interface from their devices entirely, opting instead to deliver interaction and information purely though an App . Whilst this approach doesn’t automatically deliver a better user experience for all applications, it does allow for a richer user experience and the opportunity for transferring data with the cloud.
The claim with connected devices has always been that more data will lead to better products. However, that can only be the case if the data being collected is useful and is actually being reviewed. There are currently many products which collect data with no apparent use, although this may change based on the FDA’s new guidance, which has a focus on Real World Performance Data (RWPD) after the launch of the product.
Connected inhaler offerings from the likes of Propeller Health* have been touted as providing the opportunity to link instances of asthma attacks with air quality data to help patients better understand and manage their condition . Whilst these systems undoubtedly offer great potential; reaching a critical mass of users and presenting information in a way that is understandable and actionable remain challenging.
Trends and Directions
Moving forwards there are a number of notable trends that will start differentiating key players from one another. The first is privacy. In light of the recent revelations around Facebook and the US elections, users are becoming increasingly aware of the value their data holds, and how it may be exploited. Combined with the new GDPR rules in Europe we can expect to see confidentiality and security being sold as defining factors in connected services.
Secondly, the proliferation of discreet connected devices points towards a fragmented data-landscape that users may have trouble managing. Larger players with capabilities to create a MedHealth ecosystem could end up becoming gatekeepers to connectivity, and shaping the future of the industry. Apple, Google and Samsung are making significant moves in this area.
Similarly, successful, disruptive business models are being adapted to address healthcare needs of the healthcare market. Examples of this include the recent launch of Uber Health*, which aims to provide a solution to the challenge and cost of missed appointments by providing transportation service for patients, caregivers and staff, and Amazon, who are actively looking at disruptive healthcare opportunities, with the most obvious targets being pharmacy and health insurance.
Lastly, we’ll see a few players trying to soften the impact of ‘robot jobs’, adding a sense of humanity to the digital services that will start to replace or augment the face-to-face contact that is so important. In the UK, Hampshire County Council is piloting the use of customised version of the Amazon Echo to help support people living independently in their own homes for longer, and reduce social isolation. As services become stretched this seems like a logical approach, but it will be interesting to see whether this relatively benign use of AI, will effectively replace the human connection.
The Regulatory Framework for Software as a Medical Device
As the market for connected devices and systems grows in parallel with the trend of consumerisation of health, these products are increasingly being developed by consumer product manufacturers. Whilst the technology to develop a connected device can often be relatively simple, the regulations have not developed at the same pace. This has led to frustrations in the timescales to launch products. Whilst the average app may take 4-6 months to develop. The same product, if it has a medical application, would be considered to fall into the category of ‘Software as a Medical Device’ (SaMD) by the International Medical Device Regulators Forum. In order to comply with the existing regulations, it can often take several years to release. In some cases, to circumnavigate these regulations, devices have been marketed as a consumer product instead of a medical device, leading to questions about the accuracy and consistency of the data they are providing.
As connected devices and services have become the norm, regulators are now trying to adapt at the same pace as the evolving technology. Whilst the FDA has tried different approaches to regulating connected devices focusing on risk, they have recently admitted that the ‘FDA’s traditional approach for the regulation of hardware-based medical devices is not well-suited for the faster, iterative design, development, and type of validation used for ‘SaMD’. To enable this progression, they have now engaged with 9 companies (including non-medical device manufacturers such as Apple, Verily and Fitbit) as part of their Pre-Cert Pilot Programme, with a view to developing a new regulatory framework by pre-certifying trusted partners to “either replace the need for a premarket submission or, for higher risk products, to allow for streamlined premarket review that maximizes efficiency and engagement” . This is a significant shift in approach, with the FDA historically reviewing individual products rather than manufacturers and platforms, but is expected to allow a rapid increase in the speed of development and released of connected devices. The first version of this programme is expected to be released by Dec 2018
Connectivity is Part of the Future
The fact is that connectivity isn’t going away any time soon. The necessary electronic parts that make a device ‘connected’ are becoming smaller, cheaper and more effective, and user behaviours and expectations around experience are slowly changing towards wider acceptance, and demand for, connected products. But for this to be a truly worthwhile investment for businesses, healthcare providers and consumers, the focus on the user need must be key to the development and a close eye must also be kept on assessing, testing and managing the risks of adding this functionality.