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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 3 discusses:

• How juggling multiple QA/RA roles affects SME decisions about QMS digitization.
• What resources SMEs need for QMS digitization, and how they assess ROI given limited resources.
• The future of QMS for SMEs in the MedTech industry evolving with AI and digitization.
• The role that industry collaborations or partnerships could play in helping SMEs adopt advanced QMS technologies?

Q9: How does wearing multiple hats in QA/RA impact SME decision-making regarding QMS digitization?

MK: Let me address both sides of this. Wearing multiple hats can be beneficial because you develop a broader understanding of the organization. When you're thinking about quality culture and working across departments, it helps you understand what drives the company. This is easier in SMEs because there are fewer people.

The downside is that while you gain breadth, you often lack depth. You don't always have the time to investigate things as thoroughly as you'd like. This lack of technical deep-dive time can prevent you from making the most accurate decisions quickly.

Another challenge is when you wear two hats that potentially conflict. In a prior work life for a time, I was both head of QA/RA and head of Operations – I ended up being both poacher and gamekeeper, as they say. I quickly tried to separate those roles once the business grew because of these potential conflicts. It really depends on the individual and how you're wired as to how you handle this potential conflict of interest so finding people who can effectively wear multiple hats is challenging.

PB: There just aren't enough people who can wear multiple hats to help SMEs, especially startups, on this journey. Cost is one of the biggest issues – first finding these people, then being able to pay them enough to do the job properly. That's why companies end up looking externally to consultants like Mike and Stuart. There's definitely money to be made in providing that multiple-hat expertise. It sounds strange, but we have too many medical devices and diagnostic companies for the number of people who can do these jobs. It's a capacity issue.

SA: I agree – it's such a complex role. You need to be business-aware, an excellent communicator, highly organized, and analytically astute – traits that don't always naturally go together. It's really an everything role. It works better when you have multiple regulatory affairs and quality assurance people – someone who's more of a dreamer and thinker versus someone who methodically reads everything. One person can't do everything that's needed. That's where AI could take over some of these characteristics. It just got so complicated as an answer.

Q10: What kind of support or resources would be most beneficial for SMEs looking to digitize their QMS? How do SMEs typically evaluate the return on investment for QMS digitization and AI implementation given, for example, resource constraints?

SA: Even now, it's sometime hard for people to visualize. They’re used to paper-based QMS, or digitizing paper-based QMS into SharePoint or QPulse or utilizing data, so that's difficult to envision, not just in terms of value, but how does it work connecting with ISO 13485, linking up with ISO 14971? How do we bridge the gap between human digitization and the international best practices that are embedded in our industry? Once we can do that, people will say, "Oh, I see what I can do now" or "I see the value in that." Until then, we're always going to struggle.

MK: It's multifaceted. We almost need that explained. Best practices are key.

PB: The first thing an SME needs to understand is what they want their QMS to do, and what it contains. Then as a resource, people like Mike could help by saying, "We have a solution for this particular part of your Quality Management," or others might suggest where AI could be added. So, you've got the resourcing at the end, the understanding at the beginning, and figuring out what you want to do in the middle.

Here's an anecdote from when I worked at a medical device company in a past time – nothing to do with digitization specifically, but they allocated new computers based on seniority rather than ability. Everyone needed to author emails and memos, but they gave the best computers to people who didn't even know how to use them. Complete waste. You must understand what you're doing, why it's part of your business, and then apply digitization and AI techniques to make your job easier.

SA: And it’s also key to ask, “what problem are you trying to solve?”

MK: It’s blending the right elements. You've got to get the technology expertise and blend it with those who understand the company and the clinical environment of their solutions. Then you've got to get the quality and regulatory professionals focusing on the value of digitization. What's the most significant opportunity, what's the benefit, and how do you yield the most value? Looking at the rising generation, they're much more tech-savvy, particularly with touchscreen tech and AI. But you've also got those with industry experience who understand the clinical context of products. Combining these elements with focus really makes the difference for SMEs.

The same principles apply to bigger corporations – it's just a broader discussion. With an SME you might look at one or two key things, while a larger corporation might plan a phased program over a longer period.

Q11: How do you see the future of QMS for SMEs in the MedTech industry evolving with AI and digitization?

PB: Everything we've discussed is right, but here's the danger: when you add more technology, you risk creating solutions for problems that didn't exist. All these solutions we've talked about are great, but you've got to stick to those 12 or so core principles of QMS. If you start adding too much digitization and AI, it might suggest things you could do that just make your job more complicated and harder to understand. The two words my predecessor taught me about QMS still apply: appropriate and proportionate. If you go beyond that, you overcomplicate things. That's a real risk with some of these digitization and AI processes.

SA: I've seen certain QMS solutions that provide out-of-the-box workflows with AI and all the elements built in. But as we said earlier, that doesn't fit all cases. Having AI is great, but we still need that curated understanding of what a business needs.

A key to curating a strong digital QMS solution is about knowing your company’s purpose. As a business, know what you're trying to achieve. What's the goal you're walking towards? You can buy the most optimized system in the world, but it means nothing unless you really know what you're trying to achieve.

MK: A usual phrase is that the role of QA/RA professionals and the companies they work for is in the provision of safe and effective product solutions that are commercially viable. Technology is an enabler of that deliverable. If organizations pivot the wrong way and technology becomes the deliverable, you can end up with a solution that's quite restrictive, costs money, and slows down the key customer deliverable. Tech should be the enabler of the customer facing deliverable, not the deliverable itself. That focus helps ensure you deploy things in a way that's focused and cost-effective.

I always think of it like making music and creating your own personal mix tape – in the 80s and 90s you had a limited number of tracks that could be stored on the recorded media of the time and, in a sense, that drove the quality of what you would choose – but now you've got a practically unlimited number of tracks that can be recorded in digital media, and the temptation to throw in a lot of stuff into a personal playlist can undermine the quality of the overall product.

We can sometimes see this principle of information overload in company newsletters, for example. Companies often get feedback that people aren't aware of what's going on in an organization. So, the organization moves from no newsletters to twenty newsletters as each department and cross functional team responds to create an information stream. But guess what? I'm not going to read twenty newsletters, so I still don't know what's going on. Finding that sweet spot is crucial. If every department sends out their monthly newsletter, no one's going to read it. The same risk applies to systems – you need to understand which quality process serves what purpose for your organization at what point in its journey. If you try to deploy everything everywhere all at once, the organization will struggle to use it.

Q12: What role do you think industry collaborations or partnerships could play in helping SMEs adopt advanced QMS technologies?

SA: I think it comes down to networking and collaboration – that's one of our industry's strengths. It's already hard enough to get through regulatory hurdles and navigate quality requirements. ABHI does a wonderful job of connecting, understanding, and inspiring. That's how we can approach regulation and get AI and QMS digitization adopted more widely, earlier, and in a more pragmatic way – or what was it? Appropriate and proportionate, yeah. If we can change the narrative of QMS from being this nebulous, bureaucratic thing to delivering what you want, then we've done our job.

PB: Adding to Stuart's point, we need to be realistic and understand that QMS are audited by Notified Bodies or Conformity Assessment Bodies in Great Britain, and their view of QMS can be completely different from how you try to implement it in your company or SME. So, collaboration isn't just about manufacturers – we need to see the stakeholder map and partnerships as a much wider network. If we don't bring the notified bodies or Conformity Assessment Bodies along in this discussion, they'll keep auditing like it's the 1980s. They're becoming more risk averse as regulations get more complicated, creating an even bigger gap.

MK: Everybody needs to understand the advancements in digital technologies to ensure QMS works as an enabler rather than anything else. Trustability of new technologies is also key to broad industry uptake, and this is where industry partnerships can help.

SA: We saw this with technical documentation when IVDR first came out – the big companies were first to comply, providing thousand-page technical files that met the legislation. We need to find balance because SMEs have limited resources and need to be effective at meeting the very same legislation in a way that isn’t overkill nor determined by the most complex industry response. Similarly, we can't just look at the top-end, A-style version of AI and QMS digitalization. We need to consider what the industry is doing and balance it, so we don't exclude SMEs with limited resources.

MK: Absolutely. You can be efficient but not effective, and you can be effective but not efficient. The danger comes when the industry skews toward organizations that can be effective but not efficient, and that becomes the gold standard – it comes at an increasing cost for the rest of industry, especially SMEs.

However, as the industry as a whole land on understanding how AI enabled QMS solutions can drive tangible, operational value to SMEs as well as the larger corporations, the future will be bright and exciting in enabling QA/RA professionals to support the innovation pipeline and their company’s provision of safe and effective product solutions in global healthcare markets.