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Reflections on two themes from the day;

- Usability: Continuity from marketing, through R&D, to regulatory
- Connected devices and systems: Realising the benefits

Usability: Continuity from marketing, through R&D, to regulatory

We were struck by the frequency at which we heard terms like “usability,” “workflow” and “seamless integration” during presentations on the latest cardiology suites – and by the consistency of that message across different vendors.  That’s in addition to the usual array of “smaller, faster, smarter” innovations which indirectly claim usability benefit.

We continue to be impressed by the variety we see in device companies’ approaches to usability as a function.  Since regulators took steps to clarify expectations around identification and mitigation of use risks from around 2007 (e.g. IEC 62366) there’s been a tendency for human factors / usability engineering to be addressed by regulatory departments.  We believe this approach places unnecessary constraints on achievable levels of both use risk mitigation (as required by the regulator) and especially user experience (not required by the regulator - but critical to market success)!

Happily, companies are increasingly realising that given their investment in bringing users and devices together for formative usability studies, an efficient opportunity exists to develop the user experience in parallel.  Hence we see the beginning of the rehabilitation of usability engineering as a function within R&D and new product development (NPD) groups –alongside other engineering disciplines.  Interesting variations include summative studies being run by the marketing team at one company we met, which stands to reason given the marketing function’s historical focus on user requirements.

However, rarely do companies achieve the continuity needed between upstream marketing, R&D and regulatory functions.

We strongly believe that both use risks and user experience should be tested from the earliest stages of concept development – enabled by means of prototyping at an appropriate level of fidelity for the stage of development.  In order to extend this continuity right back to upstream marketing it’s essential to objectively identify and prioritise user needs, to support development of a compelling set of user requirements before commencing concept creation.

Concepts can then be generated against user needs which are known to be both important and poorly met; and user-tested for how well they meet those needs. This is appropriate and seems obvious once articulated, especially considering the logical alternative: generating concepts in a vacuum and user-testing them without clear objectives.

Nevertheless in practice it remains a rarity to seeing this level of continuity, meaning that the competitive advantage available for getting it right should be compelling.

Connected devices and systems: Realising the benefits

With the global cardiac monitoring market projected to be worth $28 billion by 2021, it was no surprise to see numerous connected monitoring devices at ACC.  Whilst various innovations were on show, most fell into two groups: implantable cardiac monitors (ICMs) and mobile (wearable) cardiac telemetry devices (MCTs).

The prize for the successful development of this segment is surely great.  For example, up to 40% of ischemic strokes are caused by asymptomatic atrial fibrillation  and such cases are increasing.  Screening for (treatable) atrial fibrillation using low-cost devices and efficient systems promises to slash this figure, with clear benefits for patients and payer alike – but how to realise these in practice?

In hardware, we’re seeing a move away from dedicated “bedside” uplink devices (Medtronic’s Reveal LINQ), to Bluetooth smartphone connections (St Jude’s Confirm RX ICM), and perhaps towards on-board 3G/4G connectivity (National Cardiac’s upcoming Liba3 MCT).  The on-board option is not inevitable: whilst the Bluetooth solution has its challenges, the potential benefits are significant.  Challenges include regulatory (“app as medical device”) and cybersecurity (see James Baker’s column, Med Device Online).  However the potential benefits of Bluetooth versus on-board uplink may prove compelling, for example:

- device cost, weight and size;
- linking ECG data with patient observations (St Jude’s;
- enhanced patient engagement (and adherence) via app.

Done right, the adherence point may prove decisive.

The system side proved the more compelling conversation topic at ACC.  How should the system be developed in order to deliver the hoped-for benefits?  For example:

- Who will provide diagnoses based on these vast streams of data, and how will the health economics and reimbursement develop to support this activity?
- “The Cloud” will be a key enabler, as everyone seemingly agrees, but what functions will it provide?  Can algorithms make diagnosis more efficient – and, given the human challenges around accurately reviewing reams of data, less error-prone?  How will such algorithms be validated?
- Can the data from these devices be effectively made available to other parts of the healthcare system?  For example as an input to regular health checks, or to provide ECG history during treatment of adverse cardiovascular events?
- Can algorithms support clinical and treatment decision making by leveraging anonymised “cohort databases” of ECG data paired with treatment outcomes?

Much work remains in this space, and whilst improving device cost and usability will be important, the wider system view will be essential to achieve the prize!


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