Using data to bring innovative products to the market … and keep them there
This article on data and innovation in healthcare was first published by the Westminster Health Forum following its keynote seminar on 1 March 2018: "Improving access to medicine: pricing, regulation and implementing the Life Sciences Industrial Strategy"
The quicker that innovative medical products get into the hands of clinicians, the sooner that patients will benefit from the latest treatments and the more likely it is that hospitals will reap the rewards of efficiency savings.
However, Professor Mike Hannay (Managing Director, East Midlands Academic Health Science Network and Chair, AHSN Network) explained at the Westminster Health Forum on 1 March 2018 that the UK as a whole is not making the most of innovation in healthcare. The relatively slow rate at which innovative medical products are adopted means lost opportunities – bad news for patients and hospitals alike.
This trend can be reversed if better use is made of data. In response to comment from the floor at the Forum, Professor Hannay emphasised that it is critical for manufacturers to ensure that they have maximised the potential of published data on a product's performance, before the device is released to the market. Doing so means that users have confidence in an innovative product and so are more likely to adopt it quickly.
But data on clinical performance are not just important to bringing products to the market – data can be essential to keeping them there. Performance data can also be deployed to defend speculative litigation against manufacturers that arises once products are being used.
Faced with the prospect of litigation data, collected via clinical trials, and once the product is in the field, can be deployed for a number of reasons:
Reassuring the "worried well". The media and public are fascinated with healthcare products. The distinction between "patients" and "consumers" is increasingly blurred and the media find that stories on innovative medical products sell newspapers. But what sells even more? Articles about new medicines or devices that have not performed as well as some people had hoped. If a product is targeted in this way, manufacturers are well advised to get on the front foot as soon as possible and defend their product, by talking to the media, and providing information to patients. If they do not, then manufacturers run the risk that patients - who would otherwise have no complaints about a product - become concerned and contact lawyers. This task will be much easier for manufacturers if they have ready access to credible and well-presented data measuring safety and performance.
Engaging with regulators. If regulators, such as the MHRA in the UK, receive negative reports regarding the performance of a product then manufacturers may have limited time in which to respond to the regulators' enquiries. Positive and early engagement with regulators makes it more likely that public statements or actions about a product are proportionate. This in turn means that the public is provided with better, higher quality, data and mitigates the risk that lawyers or the media fill an information vacuum.
Adding to scientific debate. Sometimes, the seeds of litigation are sown in the rarefied soil of academic journals. Enterprising journalists may stumble across research that raises concerns over a medicine or device and use the findings for their own article in the mainstream media. In the event of litigation, largely forgotten papers that had been gathering dust are debated between experts in court rooms. To pre-empt these risks, manufacturers should ensure that data are collected and discussed in peer-reviewed publications. Manufacturers will then have academic papers at their disposal to respond to scientific concerns with like-for-like publications.
Mounting a robust defence. The medical device community bears the scars of high-profile litigation in recent years. In some instances, some products that did in fact meet acceptable levels of safety and performance, were unfairly dragged into litigation (metal-on-metal hips and pharmaceuticals provide examples). One of the best ways to avoid being swept up in such litigation is to ensure that performance data are collected and to hand.