Humans-in-the-Loop at the Veeva MedTech Summit

From May 11-13, representatives from over 100 life sciences companies gathered in the Windy City for two days of content presented by medtech and industry leaders at the Veeva MedTech Summit. With over 500 attendees, over 40 sessions on eight different topic tracks, and more than 40 industry speakers, the Summit aims to help attendees build their network, spark learning, and explore innovations.

The host, Veeva, provides software, artificial intelligence (AI), data, and consulting services and technologies for life sciences R&D, quality, and commercial applications. Veeva MedTech president Seth Goldenberg explained in his keynote speech kicking off the event that Veeva seeks to build the industry cloud for life sciences and provide expertise in software, AI, data, and business consulting.

The company was kind enough to fly me in for the conference so I could attend a few sessions and sit down with medical device industry leaders.

One presentation detailed the impact of the FDA’s Quality Management System Regulation (QMSR) on medtech innovation. As organizations are surely aware, the QMSR Final Rule reached the end of its two-year implementation grace period on Feb. 2 of this year. FDA policy analyst Daniel Walter explained that the main difference in QMSR from the old rule was that risk management is now the core backbone of QMS. 

For example, now codified in 21 CFR 820.10(a): Manufacturers must document a QMS that complies with ISO 13485:2016 and all other applicable FDA requirements. More comprehensive QMS documentation is required upfront in submission and there must be a tighter link between QMS and submission data. Walter also stressed that manufacturers should move toward ISO terminology in their submissions.

Smith+Nephew’s VP of quality systems and regulatory compliance Michelle Blevins detailed the steps involved to implement a solution like Veeva’s to build a productive eQMS system.

She explained previously, S+N had a platform performing necessary tasks but lacked a good user experience. Its system hadn’t made the leap to the next level of user interface, and the potential upgrade was identified to be inadequate. The questions about selecting a new eQMS began: Does it maintain and/or improve our current processes? Are there potential efficiency gains?

More automation needs for complaint processing was a concern given the company’s 60,000 complaints per year, as well as user-friendly needs for training given over 500,000 training courses a year across more than 17,000 employees. External collaboration was a must, as well as risk management, field actions, PSUR and PMSR authoring, and inspection management.

After vetting over 30 potential solutions, S+N landed on Veeva Quality Cloud. Blevins said that by consolidating to one partner, the company met its procurement goals. 

Gore Medical’s global IT leader—product and innovation Steve Speranza spoke on aligning technology strategy with business outcomes. Speranza began by explaining the importance of digital IT alignment through the healthy distance of Gore Medical from the parent W.L. Gore & Associates. He said centralized IT can cause a lack of domain focus and expertise, causing operations to be largely siloed with minimal alignment to a cohesive, business-driven technology strategy. If technical solutions are chosen for broad applicability instead of being optimized for individual business unit needs, opportunities for technical advancement can be limited and sporadic.

Once digital IT organization became aligned to the business’ value streams, a shared strategic vision began. Speranza said this reduced costs, increased productivity, and gave more focus to high-value priorities. A true partnership could be fostered thanks to lower friction in the decision-making process.

No surprise at all, AI stole the show at this year’s event. Nearly every session I attended reached AI at one point or another. AI tools, according to many at the event, stand to make the most impact in streamlining, improving, and assisting regulatory and quality operations.

One interesting example arose from Brenda Price, director of regulatory operations for Abbott Rapid Diagnostics, Infectious Disease. Price’s division is involved with a great deal of different nations: “We have to go into all countries disease is in, and it adds a lot of complexity to premarket and postmarket management of regulatory information.” Since she needs to know what any country’s registration position at any time is, the process of identifying applicable requirements is a valuable target to automate and potentially add AI. 

AI’s usefulness for regulatory intelligence was a focus in many presentations I attended. Other hot-button topics included postmarket surveillance reporting, quality and regulatory event documentation, and the importance of clean, structured data.

One caveat nearly every presenter discussing AI mentioned was the importance of “human-in-the-loop” with any AI tools. “Look at [AI] as a brand new, eager employee that doesn’t know what they’re doing,” Alcon’s director of regulatory intelligence Denton Hickey said during a presentation. “Check everything. It’s a drafting process—go back, reread, and draft.” 

“AI is augmentation, not replacement,” Elizabeth Platt, SVP of global quality, regulatory, and clinical affairs at Bio-Rad Laboratories said in the Veeva MedTech Summit’s closing keynote. “Keep humans in the loop.”