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COVID-19 gave a significant boost to digitalisation and technological advancements. Before 2019, digitalisation was an optional step, but now, it has become a necessity. Medical device businesses have realised the need for technology as it facilitates meetings, work and carrying out operations regardless of location. The requirement of tech is no longer a luxury – it is a requirement to ensure competitive advantage and providing 'business as usual' in the event of operational disruption. It is interesting to know how medical companies have embraced this need for technological advancement.

 

Since the beginning, the medical devices market has been a very conservative space in adopting new technologies and ways of working. But the outlook towards technologies such as the Cloud has significantly changed in recent years. Nearly 10% of the industry has now reached the stage at which one can consider them to be digitised throughout. For the past five years, however, an overwhelming majority of RFPs for label and artwork management solutions have insisted on cloud services or cloud-based deployment.

 

While this requirement was previously unheard of among risk-averse medical device business leaders, there is now a clear appetite for the end-to-end digital transformation of operations. Indeed, regulatory bodies are now using the cloud themselves – prompting many businesses in the industry to follow suit.

What does Digitalisation bring to MedTech?

1. A growth market that presents a golden business opportunity

The medical devices market continues to grow and mature and, today, it is proving itself to be a highly lucrative market for businesses, growing annually in line with consumer demand – with analyst projections estimating the 2030 market size to be $745 billion.

 

This sharp rise in market value has been driven by a significant growth in demand for medical devices – and businesses are acutely aware they cannot scale up legacy systems and manual processes to grow in line with demand. Therefore, medical device manufacturers need to invest more in technological and digital advancements.

2. Technological advancements raise the bar for regulatory requirements

Today, there are an estimated two million different medical device products on the market globally, grouped into around 7,000 different ‘families’. These devices are all subject to the fancies of constantly evolving and tightening industry regulations in recent years. At the turn of the century, medical device regulations between 2000 and 2010 were relatively minimal and usually highly targeted in nature.

 

2010 to 2021 has seen further 'housekeeping' regulations, combined with major global changes – think EU MDR, UDI, serialisation, IVDR and ISO 13485 standards. This is an unprecedented volume of blanket industry regulation that businesses must contend with, even as they work to handle the wide-ranging growing pains of operations.

 

The scale of this task is simply becoming unmanageable for many business leaders – especially those in large, multinational businesses that sell numerous product ranges into several markets.

Technological advancements definitely calls for enhanced regulatory requirements and guidance from the regulations. Still, companies need to return to ground level and comply with existing changes before making innovative advances. In the near future, it is more than likely that the MedTech industry could see a giant spike in innovation and development when all the stakeholders in this ecosystem are on the same page regarding regulations and compliance.

3. Enhanced traceability down to the individual device level

The PIP breast implant scandal was notable in drawing attention to the lack of QA and traceability in the medical device manufacturing and supply chain space. Further similar issues around inferior and non-regulated replacement hip joints also intensified the demand for tighter industry regulation and traceability to ensure patient safety.

 

Today, with the introduction of Unique Device Identification [UDI] and MDR/IVDR, regulations broaden the types of products covered under industry regulation and further tighten existing requirements. Yet, these compliance demands will inevitably become stricter – regulation is a constant process, and businesses cannot afford to stand and get caught out by the next wave.

For example, every medical device currently requires some level of traceability – but this is per batch, not per product. The next step to further tighten traceability could be at the individual device level, potentially with the addition of unique codes for more granularity.

Technological advancements means that companies can successfully address new and changing requirements allowing for a relatively smooth transition from ‘old’ to ‘new’.

4. Dependences on AI while existing technologies grow and mature

Industry solutions for managing data, artwork and labelling have certainly evolved over time to address regulatory and management demands from unwieldy spreadsheets to dedicated databases, PLM and ERP systems, and today's global asset libraries. But there is still a long way to go with emerging technologies such as AI and automation now being applied to enhance specific operations such as artwork generation.

 

On the compliance side, some businesses have been trying to address recent regulations such as MDR with fully manual, paper based processes but they are learning that this is far too resource-intensive, prone to human error, and could mean that they fall behind the regulatory compliance curve and in turn, this could lead to irreversible losses to the company. If technological advancements are implemented wisely to facilitate regulatory compliance this can enable manufacturers to widen their scope and increase business opportunities.

 

MedTech developments are only at the beginning of a wealth of possibilities. Manufacturers around the world are trialling various combinations giving rise to different medical innovations that can enhance patients' lives. Our experts believe that for medical device manufacturers to secure a share in this growing market, they will need to prioritise working towards a digitally mature business model with the adoption of cloud, automation, marketing, and AI.

 

While you upgrade your technologies, don't forget the need for regulatory compliance. Feel free to connect with our experts for all your regulatory requirements.

Send us an email at mdd@mddltd.com or call us on +353 (0)91-704804