by Tej Sembi, Business Development Sopra Steria
A number of scandals in recent years, like the flawed reporting of hip replacement devices leading to huge compensation payouts and fines, suggest that the medical device industry has a problem. Do the big players really care? Well, with the work we have been doing shows that all concerned in this industry do care – patient safety is their number one concern.
The world of regulation is changing and catching up with technology. New standards and medical device directives are being introduced worldwide – from the US, to the UK, Europe and beyond. These make it clear that the industry must behave more responsibly. For example, ISO 13485 2016 extends the previous edition of the quality management system requirements for medical devices and risk.
A driver for differentiation
While this is clearly great news for the end user, there is also another positive outcome from these changes. I believe new regulatory regimes present a fantastic opportunity for medical device and implant companies to radically change the way they use and interpret product data to provide business benefit. In fact, with the right mindset, they represent a driver for differentiation and increased competitiveness.
Let me explain. Companies have to comply with the legislation, which means that they are committed to spending in this area, so does it not make sense to maximise this investment? The data will need to be collated and managed, so why not look at how it is also used by other business areas and tap into this much underused resource?
On average, companies are said to base decisions on around 20% of available data so what could be achieved if they could harness more? These untapped sources of data contain a whole myriad of information. Complying with the new regulations will give companies the opportunity to have better visibility and control over clinical outcomes and supporting data which could be used across the organisation to enhance patient safety, improve portfolio management, and improve sales and marketing alongside its vital role of compliance.
Reducing exposure to risk
Ultimately the right solution to the compliance challenge should deliver a better understanding of customer/patient needs and outcomes, gaining clarity of validation, verification and design activities and support the prediction of product lifecycles in terms of maintenance, performance, end-of-life and potential usage-based issues or damage.
The more an organisation knows about each of these areas of its business, the better able it will be to reduce the company’s exposure to litigation, improve operational efficiencies and sales opportunities and, crucially, enhance product development and patient outcomes.
Thus, regulatory compliance becomes a win-win situation all round: healthcare providers have confidence in the efficacy of the medical devices they procure, patients trust that the devices they depend on are safe and robust and manufacturers gain the customer and product insight they need to differentiate and protect their brand reputation.
What do you think, am I mad to suggest compliance is really an opportunity? Leave a reply below, or contact me by email, I’d love to hear your thoughts.