Future of Medtech Virtual Summit Recap: Here’s What You Missed

On November 19th, Greenlight Guru hosted our Virtual Summit on the future of medtech. The Summit was packed with presentations and talks from some of the most insightful experts in the industry. 

The day was split into two tracks:

• Emerging medtech 

• SiMD/SaMD

If you weren’t able to make the Virtual Summit live, not to worry. All the sessions are available for free and on-demand. And since there are 11 different sessions to choose from, we thought a quick breakdown of each would help you figure out where to start.

Here are the sessions, divided by track, plus the keynote presentation that kicked off the day.

BONUS RESOURCE: Click here to download a free QMSR Readiness Playbook packed with resources to help you prepare for QMSR.

The Future of Software for Medtech Keynote Address

The keynote address, given by Greenlight Guru’s Etienne Nichols, covered the future of MedTech across three dimensions: people, process, and product. Nichols’ theme was the necessary shift toward AI-augmented professionals who prioritize strategy and judgment over clerical work, enabled by intelligent, connected systems.

Nichols advocated for replacing legacy, document-focused compliance processes with a "learning loop" QMS that functions as a nervous system for the company. Ultimately, he argued, this integration will allow teams to move faster, innovate with confidence, and turn compliance into a competitive advantage.

"AI’s aren’t here to replace any of you. They’re here to extend you. And in medtech, that’s the shift that we’re stepping into." - Etienne Nichols

Emerging Medtech Track

The QMS Paradox: Outsourcing, Tools, and Internal Hires

This presentation by Kyle Rose, CEO of Rook Quality Systems, focused on building a lean and efficient Quality Management System (QMS) for medical device companies, particularly startups.

Rose advocated for implementing a QMS tailored to a company's size, avoiding the complexity of systems designed for large firms. Rose advocates for using fractional, outsourced quality and regulatory experts and adopting a modern, medical device-specific eQMS early in development. This approach ensures compliance, agility, and readiness for audits and acquisition, while emphasizing that companies must always own their QMS and regulatory submissions, regardless of vendor partnerships.

"The quality system really is the foundation of everything you're doing, how you do it, and how it's being documented. So without a quality system, you really don't have a company. You don't have a product." - Kyle Rose

The Investment Pulse: Funding Trends in Medtech

This presentation by Nick Talamantes, Senior Director of Market Intelligence at LSI, analyzed MedTech funding in 2025, revealing a shift from a high-volume of smaller investments to fewer, larger deals. While total capital raised is up, early-stage deal volume is down significantly compared to 2024, reflecting investors’ aversion to risk. Watch the whole presentation to learn more about IPO and M&A activity this year, as well as the outlook for 2026.

"The market has shifted from a spray and pray investment strategy to investing in fewer, larger, highly diligenced deals in med tech." - Nick Talamantes

Clinical Data: What, Why and How

In her session, Shaherah Yancy, CEO of Research Lifecycle Solutions, emphasized that clinical data is the currency driving commercial success, not just a regulatory checkbox. She stressed the difference between market access (clearance) and market adoption (revenue), arguing that adoption requires trust built on solid evidence.

Check out this session to learn how to design lean, multi-purpose global studies that answer critical business questions regarding safety, performance, usability, and reimbursement—as well as common pitfalls to avoid. 

"Regulatory clearance gets you in the door, but evidence determines whether clinicians, hospitals, or payers actually use your technology.” - Shaherah Yancy

AMA: Regulatory Trends & Changes

Etienne Nichols hosted this AMA with a great group of medtech minds: 

• Holly Cotter, Founder and Principal Consultant of White Lamb Medtech Consulting and Co-Founder of indieMedTech 

• Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group 

• Eric Henry, Senior Advisor and Head of Quality Compliance at Brooke & Associates

The session covered some critical regulatory and quality trends, including the use of AI in the QA/RA space, cuts at FDA, and the fine line between wellness tech and medical devices. Check out this engaging session to get an inside look at what’s happening in the regulatory space right now. 

"Just know that if you didn't document it, it didn't happen. Even if you don't have a perfectly established quality system, anything that you would like to put in front of an auditor or anything like that needs to be documented." - Holly Cotter

Introducing Ultralight: Quality at the Speed of Innovation

Both tracks of the Virtual Summit ended with a demonstration of Greenlight Guru’s new eQMS solution, Ultralight. In this session, Greenlight Guru’s Chi Tima demonstrated how Ultralight was designed to eliminate tradeoffs between speed, compliance, and process improvement. Ultralight provides an intuitive, flexible, and modern system where compliance documentation is constantly built in the background, allowing engineering teams to stay in their natural workflow. 

This demo highlighted real-time traceability across design and risk, configurable workflows for change management and quality events like CAPAs, and automated training management. Check out this session for an inside look at a modern eQMS.

"Ultralight was really designed for you to meet those needs without the trade offs. It keeps engineering moving while keeping quality fully covered. It’s built for adoption, not just approval. And it’s both modern and trusted.” - Chi Tima

SiMD/SaMD Track

Fireside Chat with Safebeat

In this fireside chat, Greenlight Guru’s Elizabeth Weddle sat down with Rania deLeon, President and CEO of Mina Methods and Quality Assurance and Regulatory Affairs Manager at SafeBeat, to discuss the challenges of compliance in a fast-paced software environment. Facing early pressure from an FDA submission, SafeBeat needed a system that wouldn't slow engineers down or rely on manual policing of quality. 

The solution was Ultralight, which is uniquely tailored for SaMD and integrates directly into existing engineering workflows. This enabled automated verification, release compliance, and real-time report generation, increasing both speed and confidence for the team at SafeBeat. 

"With Ultralight, the compliance lives in the same space that the engineers are working in. So it's in their code, in their automation, in their release workflows." - Rania deLeon

SaMD Reality Check: Cybersecurity Compliance and the Cost of Getting it Wrong

In his session, Christopher Gates, Founder and CEO of arsMedSecurity, gave viewers a reality check on cybersecurity for SaMD. He stressed that FDA requirements are highly prescriptive, non-optional, and non-scalable, citing the record number of hold letters being issued for deficiencies. In this session, you’ll learn more about key artifacts for FDA submissions, such as the threat model, cybersecurity risk assessment, and SBOM.

"The FDA requirements are very prescriptive and they're not optional. They're not scalable. They're not based on the size of your company. They're not based on the safety risk of your medical device. If your tongue depressor uses software, it falls under the category of cybersecurity." - Christopher Gates

Market Access and Clinical Evidence for SiMD

In this session, Snorri Helgason, VP of Solutions at Nox Medical, discussed how clinical evidence fuels market access and adoption. Knox successfully transitioned from a reactive approach, collecting only regulatory-minimum data, to a proactive, commercially-focused evidence strategy.

By segmenting the market and targeting value-based healthcare systems, Nox identified gaps in their data and collaboratively ran investigator-initiated studies to fill them. The resulting data not only supported regulatory needs but provided key differentiators and health economic evidence, driving significant global growth and market share leadership.

"Don't separate the clinical evidence from your commercialization strategy. Evidence is a product that you can use for differentiating and often impacting the reimbursement pathway that it will take." - Snorri Helgason

The Non-BS (Burdensome) QMS for Software

Ashkon Rasooli, Founder and CEO of EnGenius Solutions presented a "Non-BS" manifesto for optimizing a QMS for SaMD. The principles he laid out shift the focus from proceduralism to quality and from duplication to redundancy, aiming to balance safety with speed of time to market. Check out his presentation for an eye-opening look at what the optimal QMS for a SaMD company really looks like. 

"With medical devices, the cost of breaking things is higher, and, therefore, you have to reevaluate for yourself whether moving fast and breaking things has the benefit-risk analysis that it would have in a nonregulated environment." - Ashkon Rasooli

Introducing Ultralight: Quality at the Speed of Software

The final session of the SiMD/SaMD track was a demonstration of Ultralight by Greenlight Guru, hosted by Etienne Nichols and Joseph Argyros, President of Medtech Dynamics. This time, the demo highlighted the features and benefits of Ultralight for teams working on software-enabled devices. 

The session covered how Ultralight’s SaMD ready setup minimizes the compliance burden on development teams, integrates with dev tools like Jira and GitHub and offers built-in SBOM management and flexible release control. Check out this eye-opening session if you’re looking for an eQMS that’s built for SiMD/SaMD teams. 

"A quality system should be a catalyst. It shouldn't be a burden. So I use tailored solutions that are right-sized for each company that I work with." - Joseph Argyros

BONUS RESOURCE: Click here to download a free QMSR Readiness Playbook packed with resources to help you prepare for QMSR.

Get a modern, flexible QMS built for medtech 

The future of our industry will be shaped by the people and companies who keep looking ahead and moving medtech forward, without losing sight of the patients who are at the heart of everything we do. Keeping one foot planted firmly in the present while the other takes a big step into the future may be tough, but with the right tools, it's not impossible. 

With Ultralight, medical device companies no longer have to choose between a system that works for Quality and one that works for Product. They don’t have to choose between rigid compliance or flexibility that creates risk. They don't have to choose between trust and modern, intuitive workflows. 

If you’re ready to see what a QMS solution without tradeoffs looks like, then get your free demo of Ultralight today.