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Small and Medium-sized Enterprises (SMEs) need to navigate many constraints in order to succeed. Whilst driving commercial growth and bringing innovative and potentially industry changing therapeutic solutions to market, they need to operate in a complex and evolving regulatory environment with significantly less resources, less global footprint, and less lobbying power than their MedTech and In-Vitro Diagnostic Top 50 counterparts. It is for this reason that having an industry voice (such as the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostic Association (BIVDA) is key as collectively their influence is greater when they use the sum of the SME parts.

In this three-part blog series roundtable discussion, Stuart Angell, Chair of Regulatory Affairs Working Party, BIVDA and Managing Director, IVDeology Ltd. and Phil Brown, Director, Regulatory & Compliance, at the ABHI join Mike King, Senior Director, Product and Strategy, IQVIA share their unique perspectives on the challenges of SMEs in the MedTech industry regarding Quality Management System (QMS) digitization and AI adoption, considering their resource constraints and specific operational context. They look at the variables at play for SMEs in their QMS digitization journey, when SMEs would likely uptake AI, and how industry could best help the Quality Assurance and Regulatory Affairs (QA/RA) professional who often wears many hats at an SME.

Part two discusses:

• The benefits that SMEs can anticipate from digitizing their QMS and incorporating AI-driven automations.
• When is AI adoption feasible for MedTech SMEs, and how does global presence impact QMS digitization plans?
• How industry associations can support and aid SME digitization efforts.
• How SMEs balance the need for innovation with regulatory compliance when considering QMS digitization.
• Most promising AI applications for QMS in the SME context.

Q4: What benefits can SMEs anticipate from digitizing their QMS and incorporating AI-driven automations?

MK: It will save time, improve predictability and timeliness of core processes, and allow QA/RA professionals to invest a greater percentage of their time in strategic, customer facing activities that drive improvements in product quality and market access of company solutions.

SA: AI will spot challenges and issues that weren't immediately obvious. Going back to Mike's point (in part 1 of the blog), it's easy to get overwhelmed by the sheer volume of data out there. But by focusing AI's capabilities, you can cut through all that noise and zero in on what really matters – the most critical data for improving your device's safety and performance.

PB: It really comes down to time and consistency. Using AI and digitization properly could mean that an SME's quality management system ends up being comparable to what the big companies are using, since they're built on the same principles and algorithms. For SMEs, this can make them more commercially attractive, especially when considering their exit strategies. Having this level of understanding through AI and digitization opens up opportunities that might not have been available otherwise. It all therefore, ties back to commercial performance.

MK: All these benefits we've discussed really drive commercial performance. You're looking at improved process effectiveness, better efficiency in both processes and time management, and enhanced compliance. It reduces the need for heroic individual efforts to get insights.

One thing we don't discuss enough, particularly for QA/RA professionals, is improved employee engagement. When you work in an organization where AI handles administrative tasks, you can use your technical expertise to focus on product development, market access, and commercial performance, which benefits patient outcomes. I think there's a real opportunity here for QA/RA professionals to have more fulfilling roles as these AI technologies become available to SMEs. Even just moving from analog to digital systems, without AI, can deliver some of these benefits we've talked about. If you can get the strategy right, you're well on your way to success.

SA: Without a strategy, you don't have a product. By offloading certain tasks, we as AI professionals can step back and survey the horizon, helping companies determine their direction. That's powerful when we can achieve it.

Q5: At what stage of growth or development do you think AI adoption becomes feasible for an SME in the MedTech industry? Does an SME's global footprint (or lack thereof) affect their approach to QMS digitization?

MK: Well, as usual in QA/RA, the answer is "it depends." Looking at what we've discussed, AI tools can be incredibly valuable for regulatory intelligence, helping companies understand global market requirements for both market access and design parameters. This is especially helpful for companies looking to expand either in product portfolio or geographic footprint.

It's particularly relevant for companies working with unique technology. Take Software as a Medical Device (SaMD) versus Medical Device Software (MDSW). AI-driven insights can help you understand the nuances between the two and what you need to do to launch in Europe versus America and other global markets. This can really drive efficiency for SMEs focused on software as not all global markets are the same in their market access/ product registration requirements

On the post-market side, we're seeing impressive results with natural language processing (NLP) software optimizing case capture for complaint handling processes. Remember, no matter what you're selling, you need a complaint handling process – it's fundamental. Using technology to reduce the administrative burden of searching for information and streamline how customer or patient data enters your system creates real value.

SA: I agree with all of that, and I think the backend, just before CE marking or post-market, is where things get interesting. Think about CAPAs, non-conformances, and analyzing operational processes – AI can help identify flags and risk management indicators, even if it's not handling everything.

Using AI for risk management makes perfect sense because it feeds into every part of the QMS process. It can help factor in all the triggers and flags you're seeing throughout the system. From an external perspective, it helps with state-of-the-art assessment and clinical performance evaluation. You can mine data to understand trends in medicine and the market, which feeds back into performance evaluation and design changes, and therefore into risk management.

PB: Adding to what's been said – I'll give you a typical regulatory professional response and say ‘yes’ and ‘no’ to how the SME journey of digitization could be standardized. ‘Yes’, because globally we should all be following the same quality management system standards. And with the US moving in that direction with Quality Management System Regulation (QMSR), we should all be using the same 12 or so ‘critical’ procedures that form the foundation of a quality system. But ‘no’, because the implementation and auditing of QMS, even though it's a standard, can vary across regions and conformity assessment bodies. This is where AI and digitization can help identify these nuances and ensure you're operating on a more level playing field across different territories.

MK: Let me give you an example. Patient data handling in Chinese cybersecurity and European GDPR have different but equally strict requirements about what information can be shared and why. This affects devices or software that capture identifiers and could impact your marketization process. It might even influence where you manufacture – you might need to consider manufacturing certain products within China if that's your target market.

Global expansion can also affect your quality management certification scope. Take serviceable products, for instance. I used to work for a company that have these brilliant and sophisticated diagnostic devices that need maintenance. When you move beyond your home country and start using distributors, you might need third-party service providers to support this maintenance activity. This completely changes your quality management system scope – you need 3rd party partner verification processes, training processes, record keeping, all of which create potential gaps against the existing system that may be in use.

A key challenge we haven't explicitly mentioned is culture and communicating QA/RA's value. If QA/RA is seen as just a necessary evil, it's hard to embed a culture of quality into the organization. But if it's viewed as a business enabler, and if QA/RA can frame activities in commercial terms to a non-technical audience, you can create a quality culture rather than just a quality product. This affects how you approach local versus global expansion, and depending on your quality culture, your SME's journey might look quite different.

Q6: In what ways can or do industry associations support (such as ABHI) and aid SME digitization efforts?

PB: From a trade association perspective, the key role is advocacy, particularly with regulators. While regulators should not be considered as barriers, it's about changing the culture within auditing to understand digital processes. You need to convince people that you're using digitization or AI to enhance what they're examining, not fundamentally changing things. I think it's similar across other industry structures – it's fundamentally a regulatory issue. It's also about being involved in standardization. Standards are where these developments should be considered and shaped, and both of you are involved in developing and updating them.

The third piece is about Trade Association members. We need to ensure they understand these concepts because things like ‘big data’ can feel abstract. It's about breaking it down into concrete benefits – what's the actual value of using AI? What's the tangible benefit of integrating AI into your QMS? People need to see real test cases and clear value, not just view it as another burden or cost. There's often a perception that this is only for big businesses, so we need to explain, help people understand, and support implementation.

MK: Healthcare equity is another crucial aspect. Many working groups in different industries are run by larger corporations – they have the resources and money to invest. This can lead to lobbying and directions that favor the top companies in MedTech and IVDs.

Having organizations that amplify SME voices while advocating for healthcare equity helps ensure these solutions consider SME needs within the industry needs as a whole. It also protects the innovation pipeline, since so much innovation comes from SMEs before being acquired by larger corporations – it's often easier for big companies to buy innovation than create it internally.

These trade and industry associations are vital for representing the collective SME voice and maintaining balance in working groups that are typically dominated by bigger companies. It's a delicate balance though – industry associations often get most of their revenue from large corporations when annual membership fees are based on company size, however the innovation pipeline that may come from the SMEs making up 80% of the trade association’s members needs representation.

Q7: How do SMEs balance the need for innovation with regulatory compliance when considering QMS digitization?

SA: I'd say the ecosystem itself hasn't figured this out yet. The regulators aren't really driving this yet. If we had a stronger connection between regulatory compliance and built that into international standards for state-of-the-art QMS and medical device and IVD quality systems overall, we'd have a clearer path forward. I'm not sure I know what the answer would be.

PB: In an SME, most things come down to cost and money. Regulatory compliance costs have been skyrocketing, especially in Europe with MDR and IVDR compliance, and they're likely to increase further when we consider what's happening in the UK with registrations and UK CA marking and all that that entails.

As regulatory compliance costs rise, you're taking money away from potential innovation. You're spending less on innovation because more is going to regulatory compliance. Now, digitization and processes that help reduce compliance costs could potentially free up that money to boost the innovation pipeline.

But here's the thing – for SMEs, innovation is their lifeblood. If an SME isn't innovating, it's not going to survive. So, while I don't have specific figures to back this up, it seems logical that there needs to be a balance where regulatory compliance isn't so burdensome that you can use these processes to free up funds for other activities.

Q8: What specific AI applications do you see as most promising for QMS in the SME context?

SA: From our conversation, I'd say post-market surveillance, state-of-the-art assessment, and tracking regulatory changes are three key areas. These are where professionals spend most of their time just churning through documents to read, so addressing these three elements would have significant impact. We don't have that data yet with the European Database for Medical Devices (EUDAMED), but maybe that'll help – though that's a discussion for another time. But regulatory intelligence, state-of-the-art, and post-market surveillance.

MK: Same three for me.

PB: Yes, I assume your AI applications would align with those. I haven't got much to add – I think that's right.

MK: There are other applications, like production controls, but the cost of implementing AI there is relatively higher for SMEs. That's more suited to bigger organizations with economies of scale and global footprint to afford it. So yeah, I agree with Stuart's three for SMEs.

PB: I have a confession to make – in preparing for our discussion, I asked ChatGPT if AI would replace Quality Managers! Its response was quite insightful. It said that rather than replacing QA/QC managers, AI transforms the role into more strategic and impactful positions. In SMEs especially, where versatility and interpersonal skills are crucial, QA/QC managers remain indispensable for maintaining quality culture and responding to dynamic business needs.

SA: That's helpful because it ties back to the European Person Responsible for Regulatory Compliance (PRRC) – the person who can take all the data and provide a view for management to steer the ship. AI lets you spend more time on the critical role of understanding and assessing overall organizational compliance rather than getting bogged down in specific details and fact-finding.

PB: I was impressed with that response. We talk a lot about augmentation and translating, rather than replacing. As we said earlier in this discussion, we are always trying to move Quality Management from being a burden to being an enabler. If AI can be part of that process, you're immediately getting companies working in a more quality-focused way, which means you're getting a more accurate and trusted process. That's a good future, though I think we still need a procedure for it!

Go to Part 3