Executive Report: Digital Maturity in Medical Device Quality and Manufacturing

Our research found that both quality and manufacturing medtech professionals agree – their organisations need to prioritise digitalisation initiatives.

The data indicates they are often targeting the same or similar outcomes, yet departmental gaps may undercut the value of digital efforts if there isn’t a concerted effort to unify quality and manufacturing data, systems, and operations.

A majority of respondents agree: digitalisation is a high priority

Among organisations that consider digitalisation a high priority, 65% of medical device executivest feel positively about increasing the level of digitalisation and technological advancement in their processes.

Digitalisation doesn’t happen in a silo at the executive level – it’s a top-to-bottom organisational shift, department harmonisation, and product life cycle optimisation that everyone needs to unify around for it to be successful. Yet today’s medtech executives recognise that efforts to digitalise processes will always compete with other initiatives their organisations are also under pressure to deliver on.

When asked about existing digital transformation initiatives, medical device organisations reported having varied plans in place:

Just as every medical device manufacturer has unique business needs, they also have different degrees of digital maturity. To define and measure digital maturity for the study – and to help medtech companies see where they presently stand compared with where they want to be – we designed a digital maturity model with four tiers.

When shown this digital maturity model, respondents most commonly reported that their department is currently situated in the ‘Digital’ tier, while also recognising they would see significant benefits from maturing to more connected, more harmonised, more intelligent business systems supporting the product life cycle.

Respondents were quick to point out the disconnected state of digitalisation that currently hinders manufacturing efforts.

"We have fully digital systems but they aren’t tied together but rather separate distinct systems," according to a Medical Device Organisation Site Manager.

"Our core processes are digitised, but they are not cloud-based," said one Senior Manager of QA for a Med Device Manufacturer.

"We have an electronic QMS...," noted a respondent working in a quality capacity.

There are significant organisational factors driving the orchestration of a focused effort on maturation, with ’Intelligent’ as the north star. The predominant theme across the industry is that digital maturity will allow medical device organisations to better compete, and more quickly adapt to change, under growing pressures to innovate while minimising trade-offs that could jeopardise safety or compliance.

With even a modest increase in digital maturity, respondents recognise they’d be better prepared to:

• Anticipate disruptions.
• Move more quickly through approval cycles.
• Pass audits and inspections without issue or delay.
• Forecast for optimised batches.
• Predict and prevent overdue training.

These and many more benefits that come with enhanced digital maturity can help medical device manufacturers dramatically reduce errors and achieve more efficient production.

Current processes are inefficient and time consuming. The lack of data visibility make it challenging to take action, and manual tasks are prone to errors that slow operations down. Current manual processes, siloed procedures, budget constraints, and data quality concerns within both manufacturing and quality departments continue to leave many pharma companies feeling limited in their ability to scale their operations. They're unable to truly realise the benefits of being connected.

In general, medical device companies have been slow to truly adopt digital technologies. Their often paper-based, manual processes, time-consuming tasks, limited data visibility, and costs top their list of pain points and barrier preventing digital maturity.

That means many medtech organisations today continue to live in a world of trade-offs. They’re making sacrifices and losing time or opportunities to innovate, and ultimately delaying product delivery to patients. The risk they perceive in implementing and adopting a new system to mature digitally and streamline processes can significantly outweigh the delays and costly mistakes experienced with their current manual processes.

As respondents were most likely to consider themselves ‘Digital,’ it’s not surprising that a majority of medical device organisations do report having purchased a quality management system (QMS) or manufacturing execution system (MES), , which on the surface, seems like positive momentum in their digital transformation journey. However, digging into the details of their implementations, it’s evident that companies are not seeing the full value of their investment in these systems today.

MasterControl’s research revealed that few have their digital systems fully implemented across all sites. Many are stuck in limbo with a mix of disconnected systems that can leave them feeling burdened with inefficiencies across their operations that are slowing down product delivery to patients depending on them.

In addition to a lack of true system implementation is a lack of connectivity between the MES and QMS solutions that are in place. These nonexistent connections represent critical missing links between these departments that are preventing them from sharing workflows, insights, and more.

Many surveyed acknowledge the benefits of connected systems, yet they have not been able to align to make unified, connected operations a reality for their departments or the broader organisation.

The perception that introducing a new system can cost too much or disrupt operations shouldn’t stop medical device organisations organisations from taking steps to achieve digital transformation. It doesn’t have to be a daunting undertaking and it doesn’t all have to be done at once. Taking an iterative approach and having departments in lockstep along each step will be key to success with digital maturity. Quality and manufacturing teams need to work together to streamline digitalisation across their shared processes, shared workflows, shared data visibility, shared training platform for compliance, and more.

MasterControl allows you to take critical steps to deliver products without compromise, and without making trade-offs. We have more than 30 years of experience serving innovative companies in the medical device industry.

Our flexible QMS and modern EBR allows users to achieve ROI from their MasterControl investment in under a year by helping them avoid delayed deliveries and production bottlenecks, offsetting rising material prices with time and money saved automating, ultimately delivering innovations to patients faster.

• A purpose-built platform that allows you to scale across your organisation on your terms.
• Connected systems for seamless, cross-functional collaboration.
• A system that’s easy to implement and deploy.
• Low/no-code software for easy configuration.
• Native and third-party integrations to easily connect to other critical usiness systems.
• Risk-based, patented validation.
• Cross-platform, AI-powered analytics and insights.

With a robust connected system, the trade-offs you're used to making disappear, as do the gaps between departmental objectives and data. Enhanced and intelligent connectivity eliminates the need to decide whether safety is more important than speed because you can enjoy both. Most importantly, rather than forcing you to put quality in jeopardy for the sake of keeping costs low, an integrated system empowers you to achieve both by aligning product development, quality management, manufacturing operations, and the supply chain.