During a Square-1 Engineering Lunch & Learn, labeling expert Dawn Fowler shared practical strategies for building a long-term compliance plan instead of reacting to each new regulation as it arrives.

Compliance Isn't a One-Time Project
​One of the biggest misconceptions in regulatory affairs is that a five-year transition period means there's plenty of time.
In reality, large labeling initiatives often affect hundreds or thousands of SKUs, requiring coordination across Regulatory Affairs, Quality, Manufacturing, Supply Chain, Marketing, and Operations. Add inventory management, UDI updates, artwork revisions, validation activities, and product rollout planning, and those five years disappear quickly.
Rather than treating each regulatory update as its own project, organizations should look for opportunities to bundle changes together into a single implementation strategy whenever possible.

Global Requirements Will Continue to Expand
The European Union and FDA are often the focus of regulatory discussions, but they're far from the only organizations introducing new requirements.
Countries around the world continue to develop their own UDI programs and labeling expectations. Manufacturers selling globally should expect ongoing changes rather than assuming regulations will eventually stabilize.
A successful labeling program isn't built around reacting to new rules. It's built around having a process that allows your organization to adapt efficiently.

Staying Informed Is Part of Compliance
Waiting until a regulation becomes mandatory often leaves organizations scrambling.
Dawn recommends making regulatory monitoring part of your normal routine. Whether it's following standards organizations, participating in industry groups, using regulatory aggregators, or networking with peers across the industry, staying informed gives companies time to plan instead of simply reacting.
Many of the most successful regulatory professionals don't just understand today's requirements. They know what's coming next.

Your Professional Network Is One of Your Greatest Resources
Some of the best regulatory insights don't come from search engines.
Industry organizations, conferences, webinars, and peer networks often provide valuable perspective on upcoming changes long before implementation deadlines arrive. Those relationships can help teams validate approaches, share lessons learned, and prepare for future requirements with greater confidence.
Building those connections also benefits individual career growth by demonstrating strategic thinking and industry engagement.

Build a Strategy Before the Deadline Arrives
Medical device labeling has become far more than artwork updates.
Today's regulatory environment requires companies to think strategically about global compliance, UDI management, inventory planning, documentation, and cross-functional collaboration. Organizations that begin planning early will be in a much stronger position than those waiting until deadlines become urgent. The question isn't whether additional labeling requirements are coming, it's whether your organization has a process in place to manage them efficiently.

If you would like to dive deeper, here are the links that were referred to in the discussion:

• Complying with the Unique Device Identification Timeframes for Medical Devices
• The Rules for Unique Identification System for Medical Devices
• FDA Updates Human Factors Guidance for Devices

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​Most people can point to someone who helped shape their career. Maybe it was someone who gave advice during a difficult moment, someone who challenged you to think differently, or someone who saw potential in you before you fully saw it yourself. That is the power of mentorship. ​During Square-1 Engineering's Lunch & Learn, The Mentorship Advantage: Build Your Career, Legacy & Network, Trisha Aure, Senior Director of Operations & Delivery, shared her personal experiences with mentorship, both as a mentee and a mentor, and the lessons she has learned throughout her career.

For Trisha, mentorship has never been about finding someone who has every answer. It is about finding people who help you see what you may not be able to see yourself.

Early in her career, Trisha assumed having a great boss meant she had a mentor. After all, a manager guides you, challenges you, and supports your growth. But over time, she realized there is a difference between the two. While a manager can be an incredible source of support, a mentor often provides something different: an outside perspective. "An outside perspective is not swayed by internal processes, corporate red tape, or things they see every day." That outside perspective can help you step back from a situation and approach challenges differently. A mentor can challenge your thinking, offer a viewpoint you may not have considered, and help you navigate decisions with more confidence.

But before searching for a mentor, Trisha believes the first step is understanding yourself. Instead of immediately asking, "Who should be my mentor?" start by asking, "What am I trying to accomplish?" Understanding your goals, your challenges, and where you want to grow is what allows you to find the right person. Throughout her career, Trisha has had several mentors, both formal and informal, and each one played a different role depending on where she was in her journey. She emphasized that there is not one perfect mentor who will guide every part of your career. Different mentors can support different seasons of your life. One person may help you navigate leadership challenges, another may help you develop a specific skill, and another may simply provide a perspective that helps you see things differently.

A strong mentorship relationship also requires intention. One of the biggest themes throughout Trisha's session was that mentorship is not passive. The mentee has to take ownership of the relationship. That means coming prepared, knowing what you want to discuss, asking thoughtful questions, and following through after conversations. A mentor is offering their time and experience, and respecting that time is a major part of building trust. Trisha shared that she has always found value in writing down her goals and revisiting them regularly. Not only does this help her stay accountable, but it creates a roadmap for her mentors to better understand where she is trying to go.

Sometimes we know what we want, but we do not know the path to get there. That is where mentorship becomes valuable. A mentor can help you break a large goal into smaller steps and identify what needs to happen next. She also reminded attendees that growth is not just about reaching the next milestone. It is also about recognizing the milestones you have already reached. Many professionals accomplish something and immediately move on to the next challenge without taking a moment to celebrate their progress.

"You don't realize who's watching or who you are impacting because you've said this out loud."

When it comes to finding a mentor, Trisha encourages people not to overcomplicate the process. Many people believe their mentor needs to be the most successful person in their industry or someone with the exact title they want someday. But that mindset can make people miss valuable relationships. The right mentor is someone who has experience connected to what you are trying to accomplish. Someone who has faced similar challenges, developed skills you want to build, or can help push you outside of your comfort zone. Most importantly, Trisha believes vulnerability is where real growth starts. Surface-level conversations will only get you so far. The more open you are about what you are working through, the more meaningful the guidance can become.

Mentorship relationships also change as careers evolve. During the session, an attendee asked about what happens when a mentorship relationship shifts over time and starts feeling less like mentorship and more like a casual conversation. Trisha's advice was to recalibrate.
A relationship changing does not mean it has failed. People grow. Careers change. Priorities shift. Sometimes the mentor who helped you through one stage of your career may not be the same person you need in the next stage. Having an honest conversation about what you are hoping to gain from the relationship can help bring that purpose back. And sometimes, a mentorship relationship has simply served its purpose. Not every mentor needs to be a lifelong relationship to have a meaningful impact.

One of the most powerful reminders from Trisha's session was that mentorship is not reserved for executives or people with decades of experience. Many people hesitate to become mentors because they think they do not have enough knowledge to share. But mentorship is not about having all the answers. It is about sharing what you have learned. The experiences you have gained, the challenges you have overcome, and the lessons you have picked up along the way may be exactly what someone else needs. You do not have to wait until you reach the top to make an impact.

For Trisha, becoming a mentor was a natural extension of the impact her own mentors had on her. The confidence and guidance she received made her want to create that same experience for others. And becoming a mentor does not mean your own growth stops. Even mentors need mentors. Looking back, Trisha shared that the biggest mistake she made early in her career was waiting too long to seek mentorship. The biggest surprise was realizing that one day she would have the opportunity and responsibility to become a mentor herself. Mentorship is not a single stage of your career. It is something that grows and changes with you.

Trisha closed the session with a simple challenge: identify one area where you need guidance, one person you can learn from, and one person you can help.

Because mentorship is not only about building your own career. It is about the impact you leave behind.
​
Seek wisdom. Share wisdom. Repeat.

​Artificial intelligence is rapidly changing the medical device industry. Most conversations focus on AI-enabled products, from imaging software to diagnostic tools. But some of the most immediate opportunities are happening behind the scenes.

During a recent Square-1 Engineering Lunch & Learn, Tricia Cregger, Director of Quality/Regulatory for Coltene explored how AI is transforming the regulatory submission process itself. From literature reviews and predicate searches to document drafting and quality reviews, AI is becoming a powerful tool for helping regulatory teams work more efficiently while maintaining compliance.
The Opportunity Isn't Just AI Products
The FDA has now authorized more than 1,200 AI-enabled medical devices, a dramatic increase from just six approvals in 2015. While those products receive most of the attention, another transformation is taking place inside regulatory departments.
AI is increasingly being used to support the work required to bring devices to market. Rather than replacing regulatory professionals, it is helping teams manage growing volumes of documentation, increasingly complex requirements, and tighter timelines.
From Manual Processes to Intelligent Workflows
Regulatory submissions have always been document intensive.
Whether preparing a 510(k), PMA, Technical Documentation package, or Clinical Evaluation Report, teams often manage hundreds or even thousands of pages across multiple regulatory frameworks.
Historically, the solution to increasing complexity was simple: add more people, more reviews, and more hours.
AI offers a different path.
Modern tools can continuously monitor regulatory agencies for guidance updates, analyze large volumes of literature, identify potential predicate devices, and help organize information long before a submission reaches the drafting stage.
The result is a shift from reactive regulatory intelligence to proactive regulatory planning.
Faster Drafting, Smarter Reviews
One of the most promising applications of AI is document generation.
Tools can now create structured first drafts of executive summaries, risk assessments, clinical evaluation reports, and other submission documents in a fraction of the time traditionally required.
That does not mean the submission is finished.
A key theme throughout the discussion was that AI should be viewed as a drafting assistant, not an author. The technology can help teams move from a blank page to a working draft quickly, but subject matter experts remain responsible for validating every fact, reference, and conclusion.
The goal is not to eliminate human expertise. It is to allow experts to spend less time formatting and more time thinking.
Improving Submission Readiness
Beyond drafting, AI is creating opportunities to strengthen submission quality.
Advanced tools can:

• Identify inconsistencies across documents
• Detect broken cross-references
• Compare content against regulatory requirements
• Highlight potential gaps before submission
• Support version control and review management

These capabilities allow teams to focus their attention on strategic and technical issues rather than spending valuable time searching for formatting errors or conflicting language.
In many cases, AI can act as an additional reviewer that never gets tired, never misses a revision, and never overlooks a contradiction hidden hundreds of pages deep in a submission package.
Predicting Questions Before They Are Asked
Perhaps one of the most intriguing developments is the use of predictive analytics.
By analyzing historical regulatory feedback, AI models can identify patterns that may indicate where reviewers are likely to focus their attention.
Imagine knowing before submission that your product type frequently receives questions about biocompatibility, clinical evidence, or predicate selection. That insight allows teams to strengthen those sections proactively rather than responding after review begins.
While these tools are still evolving, they demonstrate how AI can move beyond efficiency gains and become a strategic advantage.
The Risks Are Real
The discussion also highlighted the importance of caution.
AI systems can generate content that sounds authoritative while being completely incorrect. Fabricated references, nonexistent standards, and inaccurate technical conclusions remain genuine risks.
In regulatory affairs, credibility matters.
A single unsupported claim can create questions about the integrity of an entire submission.
For that reason, human verification remains non-negotiable. Every AI-generated output must be reviewed, challenged, and validated by qualified professionals.
Governance Will Determine Success
Organizations that successfully adopt AI will not do so by simply giving employees access to new tools.
They will establish governance.
That includes:

• Defining approved AI tools
• Creating procedures for AI-assisted work
• Establishing verification requirements
• Training employees on limitations and risks
• Maintaining documentation and audit trails

The companies that move fastest while maintaining quality will be the ones that treat AI as part of their quality system rather than as a standalone technology.
The Future Still Requires People
One concern often raised whenever AI enters a conversation is whether it will replace regulatory professionals.
The answer is no.
AI can generate drafts, scan databases, and identify patterns. It cannot exercise judgment, build relationships with regulators, navigate complex strategic decisions, or defend a submission during critical discussions.
Those responsibilities remain firmly in human hands.
As AI continues to mature, the role of regulatory professionals will evolve. Less time will be spent on repetitive administrative work, and more time will be spent on strategy, critical thinking, and decision-making.
The future of regulatory affairs is not AI versus humans.
It is AI working alongside experienced professionals to create stronger, faster, and more effective submissions.
Final Thoughts
AI is no longer a future consideration for regulatory teams. It is already changing how submissions are prepared, reviewed, and managed.
The organizations that begin learning, piloting, and governing these tools today will be better positioned to adapt as regulatory expectations continue to evolve.
The question is no longer whether AI will impact regulatory submissions.
The question is how prepared your organization will be when it does.