Is this MedTech's 'VW' Moment?

­In 2015 the automotive industry was rocked by revelations that VW, a leading manufacturer, had cheated emissions tests, and so mis-reported the environmental impact of 11 million cars worldwide. This was not a standalone incident, but a single example of the widespread ‘gaming’ of emissions standards across the industry. It laid bare a fundamental failure in the way that cars were designed, tested, and regulated – severely impacting trust across an entire industry.

MedTech’s VW Moment – A Risk for Developers

Today it appears that MedTech may be about to have its own ‘VW moment’. The International Consortium of Investigative Journalists (ICIJ) have announced a deep and wide-ranging investigation of the medical device industry – conducted by 252 journalists from 36 countries, including high impact media partners such as The British Medical Journal, the BBC, and the Guardian.

This investigation, like the VW scandal before it, reports on individual device failures, but more broadly paints a picture of an industry plagued by ineffective regulation, poor testing, and an absence of transparency – calling into question the entire system of device design, manufacture and regulation.  In one of the most eye-catching parts of the investigation, a mesh-section from a bag of oranges, and an accompanying clinical/design file, were submitted to three notified bodies. All three declared there would be no problem in getting the device to market.

Worse, these investigations are likely only be the tip of the iceberg, with an initial focus on more highly regulated implantable (class III) devices. If such a wide-ranging set of questions can be found here, we can expect many more for class II, and in particular self-certified class I devices.

Clearly much of the focus will rightly fall on regulators and notified bodies. There is, however, huge risk for developers, who bear the final responsibility for ensuring that a device is safe, appropriate and effective. This responsibility is now (belatedly) being more forcefully addressed by regulatory bodies - for example in the new European MDR directive. Regardless, the industry must act to rapidly and radically deepen the scientific integrity behind all devices, and ensure safety regardless of regulation.

Taking Responsibility – Practical Solutions

Making this change is clearly a huge task. These are not isolated incidents but a systemic failing, needing a systemic response. Veterans of change management within healthcare will recognise the need here for strong and dedicated leadership, yet clear direction is not enough alone. Practical solutions are also needed to address the issues highlighted by the ICIJ:

1.       Deeper focus at the ‘fuzzy’ front end of innovation

No healthcare company sets out to create products that harm patients. When this occurs, the fault can typically be traced back to unforeseen interactions and mis-operation. The FDA has long talked about the large number of adverse events which can be traced back to the earliest stages of the design process.

The answer is a deeper focus by developers on the earliest stages of development, where such unforeseen operation can be anticipated, tested and resolved most easily. This is the ‘Japanese’ approach that swept the Quality Management community a few decades ago - spending more time in early development to improve quality and save time and cost downstream.

Such an approach sits counter to the current dominant culture in healthcare – focused almost exclusively on cost, regulation, and late stage design efforts. Embracing the front end of design not only addresses unexpected on-market challenges, like those now being raised by the ICIJ, but also leads to improved development costs and efficiency – by solving big challenges in the comparatively fast moving and low-cost development stages.

2.       Holistic Development and Management of Organisational Knowledge

Clearly, anticipation of potential on-market problems, and the capability to ensure safety, appropriateness and efficacy rarely rises fully formed from the ether. It is instead built upon the back of deep and broad, organisational knowledge.

This combination of deep and broad is now crucial. The issues raised by the ICIJ – hip replacements producing harmful wear debris; disintegrating spinal implants; and calcifying contraceptive implants – are multidisciplinary failures, difficult to predict and address without a holistic consideration of device operation throughout development. They show in stark relief that the siloed structure of traditional healthcare development is increasingly untenable. Device development can no longer sit apart from regulatory, who sit apart from pharma, etc.

Addressing these problems requires the removal of internal discipline barriers and the development of all-inclusive knowledge management approaches able to synthesise information from a wide range of sources to anticipate and resolve problems. This becomes ever more important for devices, where traditional barriers are being broken down by the market itself. The future of healthcare is in holistic development, with organisations seamlessly integrating drug, device, diagnostic, software, and patient factors with a working knowledge of diverse safety risks, and regulatory needs.

3.       Closed Loop Digital

Lastly, healthcare needs to rapidly realise the promise of digital technology in post-market monitoring and surveillance. This must go beyond the limited vision of dose counters and treatment calendars to closed loop monitoring of the health and well-being of patients in near real time - utilising a broad range of effective indicators. Devices themselves must also self-monitor, ensuring that any deviations from safe and effective operation are identified and addressed early – before more serious problems occur.

In most cases the technology to achieve this exists, what is lacking is the leading-edge vision to overcome the complex non-technical factors that stand between the possibilities made available by innovative technology, and its on-market adoption.

Change is Needed Now

The issues revealed by the ICIJ are systemic, requiring a systemic response. This will take some time to implement, yet the industry needs to reflect now – today – on what went wrong and how it will do better in the future.

Ultimately a wider vision is needed, beyond the deep focus on return-on-investment and cost efficiency to a more balanced view of the vital indicators for good device development. In the age of value-based reimbursement this in fact becomes a benefit: more than ever, building high value and quality into a product is a revenue-generating exercise.

Regardless, this is a wake-up call. The glacial pace of change in healthcare development processes has been shown again to be nonviable. A new view of the key drivers in device development, and a restructuring of the development process around those drivers is drastically needed as a proactive tool in addressing the challenges raised in this latest reporting. Deep and rapid change at the heart of healthcare can and must now deliver a win-win-win for developers, regulators and patients.