From Signal to Action: How Alcon and Redica Systems Put Real-Time Regulatory Intelligence Into Practice

In the global medtech landscape, regulatory affairs teams face a constant, compounding wave of change. Between internal company standards, industry guidelines, and rapidly shifting national regulations, the sheer volume of updates is staggering. For medtech manufacturers, keeping pace is a monumental task. Alcon, for example, a manufacturer of vision care products and ocular surgical equipment, operates with more than 25,000 employees serving more than 140 countries.

Historically, regulatory monitoring has been a localized, manual chore, often managed via disconnected spreadsheets. This creates an inevitable information lag, leaving medtechs reactive and exposed. During audits, a slow response can translate to costly deficiency letters, delayed product approvals, or even a loss of market access.

Denton Hickey, director of regulatory intelligence at Alcon, and Scott Sherrill, SVP of regulatory intelligence at Redica Systems, recently shared their thoughts on how companies can shift this model. By moving from a reactive “cost center” mindset to an automated, end-to-end workflow, medtech organizations can transform regulatory intelligence into a proactive driver of market access and audit readiness.

Stage 1: Policy intake and advocacy

Shaping standards before they’re finalized

A successful regulatory intelligence strategy doesn’t start when a new rule is published. It begins months, sometimes years, earlier, during the drafting stage. When regulatory bodies or standards organizations release draft documents, they typically announce a crucial window for industry feedback. Engaging health authorities early allows businesses to negotiate requirements before they become law, preventing costly, unnecessary burdens that fail to improve patient safety. Often, manufacturers with boots on the ground are able to anticipate consequences of regulatory changes that regulators themselves may overlook.

“Advocacy during drafting ensures industry concerns are negotiated before high-impact rules are finalized,” Hickey notes.

Hickey went on to categorize three different approaches to industry advocacy:

• Observer: The regulatory intelligence team monitors the progress of a draft to help internal product and engineering teams prepare for future design directions.
• Passenger: The company works quietly through industry trade associations or working groups.
• Driver: The company steps forward directly to submit comments to public dockets or lobby health authorities.

While it’s always important to be an observer, a company should consider its approach to influencing draft regulations on a case-by-case basis. The passenger approach, for instance, allows multiple companies to voice shared concerns on sensitive or controversial topics without exposing individual brand names to potential regulatory scrutiny or media distortion. But when a draft requirement threatens commercial feasibility with no added benefit to patient safety, being a driver is critical.

A multimillion-dollar advocacy win on master UDI

Hickey shared an example of how collaborative advocacy at Alcon can protect both the industry and patients. During the drafting of EUDAMED requirements, regulators initially proposed requiring contact lens manufacturers to place a master UDI on every individual blister pack.

Because contact lens blisters are extremely small, accommodating a master UDI would have required redesigning the primary packaging shell. This seemingly minor database formatting requirement would have forced manufacturers to purchase new manufacturing machinery, perform extensive sterilization validations, and undergo complete product stability re-validations.

The contact lens industry banded together, compiled data on the extreme cost impact, and demonstrated that the requirement provided zero benefit to product traceability or patient safety. The health authorities listened, and the requirement was modified.

“Sometimes it works, sometimes it doesn’t,” Hickey said. “But if you don’t speak up, you get what you get.”

Stage 2: Impact assessment and smart AI

Transitioning from summarizers to advisors

Once a draft regulation becomes official, the next challenge is scoping its impact. This is where modern artificial intelligence is proving to be a highly effective assistant.

However, before deploying AI tools, organizations must understand where they actually fit in an effective and thorough approach to regulatory intelligence. Sherrill shared a simple framework he uses at Redica to categorize workflows along an automation spectrum:

• Deterministic workflows: These are consistent, transactional, “assembly-line” tasks where input A always yields output B (e.g., data ingestion). These types of tasks are prime candidates for automation.
• Adaptive workflows: These require deep, human-centric judgment with many decision branches (e.g., making final clinical safety determinations). These tasks have low automation potential.

Most regulatory intelligence tasks, Sherrill advised, call for “conditional workflows.” These hybrid approaches benefit from automated processing but still involve expert human oversight. “AI should be a conditional regulatory advisor to surface urgency and next steps—not just a summarizer,” explained Sherrill.

By applying AI to the conditional segments of the workflow, medtech companies can significantly compress the time it takes to move from regulatory signal to internal action. Practical applications include:

• Automated differencing: Rather than requiring a subject matter expert (SME) to read through a 200-page updated standard line by line, AI can instantly run a document comparison. It extracts exactly what clauses changed, giving the SME a targeted checklist to review.
• Regulatory horizon scanning: Teams can use AI to crawl public health authority portals globally to track and forecast upcoming requirements.
• Internal database cross-checking: In advanced setups, AI can connect directly to standard operating procedure (SOP) databases to scan internal protocols and past submissions, identifying exactly which documents are impacted by an external regulatory change.

Both Hickey and Sherill emphasized that, while AI is an incredibly useful and eager assistant, it must never be left unsupervised. To guard against confident but incorrect answers, organizations must enforce a strict “human-in-the-loop” model, instructing users to write targeted prompts that force AI to cite specific clauses for verification.

Stage 3: Integration and audit readiness

Connecting intake directly to implementation

The most sophisticated policy intake and AI-powered gap assessments are of no value if the organization fails to execute on the ground. This execution gap is where many traditional regulatory intelligence models fall short.

“Previous steps are irrelevant if the regulatory requirement is not implemented within its given transition time,” Hickey emphasized.

Historically, regulatory intelligence teams would identify an applicable standard, email it to local manufacturing facilities, and consider their job done. However, local facilities face competing priorities, thin resources, and operational bottlenecks. Without central visibility and accountability, implementation can stall, leaving the company quietly out of compliance.

To bridge this gap, Alcon shifted to a modern approach that connects regulatory intelligence directly into internal change control processes, enabling:

• End-to-end tracking: Moving from static, error-prone spreadsheets to a unified end-to-end system allows real-time tracking from the moment a signal is captured to the final implementation at the facility level.
• Active governance: Establishing cross-functional regulatory intelligence councils ensures that leadership can negotiate budgets, align resources, and manage competing priorities.
• Audit readiness: When an auditor asks to see a gap assessment against a newly effective standard, or when a submission requires proof of compliance, a unified system allows the team to retrieve the exact gap analysis, action items, and implementation records instantly.

Conclusion

Proactive compliance drives market access

Regulatory intelligence is far more than a defensive administrative function; it is a critical contributor to business continuity and commercial speed.

To move away from reactive firefighting, organizations should start by breaking their regulatory workflows down into digestible pieces. By automating data intake, leveraging a unified subject matter expert network, and strategically utilizing AI as an aide (not an autonomous agent), medtech companies can build a defensible, state-of-the-art compliance program. Unifying these processes on a single platform ensures that when global regulations change, a business can adapt without skipping a beat.

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Hear Denton Hickey explain how an end-to-end reg intel system at Alcon increases visibility, audit-readiness, and the ability to measure success.

Disclaimer: The views and opinions expressed by Mr. Hickey are his own and do not necessarily reflect, represent, or constitute the views, positions, or policies of Alcon. Any statements should not be interpreted as an explicit or implicit endorsement, approval, or recommendation by Alcon.