If there’s one thing medical device manufacturers want consultants and software vendors to know, it’s that their activities and requirements for managing and dealing with information, whether for regulatory compliance or internal operational reasons, are NOT the same as those of pharmaceutical companies.
Yes, device makers’ needs for structured information management are substantial and growing, to keep track of quality, safety, registrations and authorisation of variations in each target market. But producers of medical equipment and combination products have their own sets of criteria to meet and their own particular challenges. Crucially, they do not operate with the same commercial terms as pharma companies: in the main they do not have budget to spare to invest in huge software systems. Especially if these were clearly designed for drug R&D organisations or marketing authorisation holders and have been subsequently ‘adapted’ for adjacent markets.
This may give the impression that medical device manufacturers have run out of patience with the technology vendor and service provider community – and to some extent they have. Their practical, information-based challenges are considerable and growing, but this doesn’t mean that they are going to be grateful for ill-fitting, repackaged solutions.
A shoehorned solution won’t do
So what is it that device manufacturers need, and what is driving the current wave of interest in digital systems for managing critical processes?
There are three main motivators for improvement, currently. These are:
- Rising regulatory complexity. Across the world, the authorities now recognise the need for more sophisticated controls over the quality, safety and traceability of medical devices, whether these are diagnostic machines used by clinicians, physical aids for patients or smart, devices or monitors worn by or implanted into individuals. The more detailed and up-to-date the information required by regulatory agencies, the more vigilant manufacturers need to be about capturing, checking, reporting and maintaining it.
- The growing diversity and sophistication of medical device products. The ‘medical devices’ sector was already pretty broad in scope, but the category has expanded further now to include 3D-printed joints, artificial bones and mind-controlled limbs to complex combination products which may involve the live transmission of real-time data to determine next actions/medicine dosage. All of these advances are informing new waves of R&D quality and safety requirements.
- An appetite to harness next-generation technology – from AI to big data analytics. Emerging options offer new potential which manufacturers could harness to improve the efficiency of their quality/safety/regulatory information management and if device manufacturers fail to capitalise on these opportunities they could lose ground competitively.
Drivers for change – and how to approach it
For ‘new’ medical device market entrants – including the big tech companies like Google Health and Apple – which are coming at the opportunity from a culture of short, swift, incremental technology innovation cycles rather than device creation under strict regulatory scrutiny, the challenges are likely to be linked primarily to compliance. For more established manufacturers – particularly those operating on a small or modest scale (ie not the major global electronics brands) – issues are more likely to revolve around operational process efficiency.
Although individual regulations, such as the EU Medical Device Regulation (MDR), are likely to be too specific or too highly evolved to spark next waves of digital transformation progress in their own right, the call to roll out standardised, traceable digital capabilities across operations offers all kinds of operational benefits. It also presents a chance to lift confidence in quality and safety, and the company’s ability to routinely and reliably demonstrate this.
It may be that a major change that’s planned to the product portfolio that prompts a process review and triggers digital transformation. Or it may be the realisation that change must happen at some point – and that there will never be a better time than now.
Whatever the driver(s) for process improvement and enhanced data management, medical device manufacturers have a head start with structured information management, coming from an engineering perspective rather than a purely scientific background. This puts them in a relatively strong position when moving forward with digital transformation using the latest platforms and solutions.
The next step is to identify the right partner to advise on how to move forward. We generally dissuade companies from taking a big-bang approach to digital transformation, in preference of phasing the migration to a modern platform – at a pace that fits the variety and complexity of each company’s particular product portfolio – to create strong foundations they can build on over time.[ENDS]
Peter Brandstetter is a Senior Manager for Technology Consulting at Accenture in Zurich, Switzerland. A respected authority in IT-enabled transformation in life sciences, he has more than two decades’ experience of solving complex IT challenges for pharmaceutical companies globally -gained across senior life sciences consulting/IT roles including Life Science Central Region Lead at CSC, Senior Managing Consultant for GBS Life Sciences at IBM, and Senior Manager at PwC.
Peter specializes in quality management and quality assurance in manufacturing and R&D, enterprise content management, and R&D (clinical data management, pre-clinical, R&D Lab, R&D collaboration and project management), as well as computer validation.
Accenture is a systems integration/consulting partner of Generis.