By Mehr Sokhanda
As the global healthcare sector faces mounting challenges—from aging populations to rising costs—technology stands at the forefront of transformation. In a recent session hosted by Brampton Angels, Nick Kuryluk, CEO of CoSality, investor and commercialization expert, unpacked what angel investors need to know about MedTech innovation and investment. With a background spanning biotech strategy to startup leadership, Kuryluk offered an insider’s view into the risks, trends, and tools shaping this dynamic field.
1. MedTech’s Driving Forces: Meeting Urgent Healthcare Needs
Kuryluk laid out the foundational trends pushing MedTech to the forefront of global health innovation. These are not abstract forces—they are direct responses to pressing issues like hospital staffing shortages, population aging, and healthcare system inefficiencies.
“Artificial intelligence is everywhere… transforming hospital processes and systems for a more efficient way in our healthcare systems,” said Kuryluk
These trends span ten critical areas, including telehealth, robotics, preventative care, and healthcare equity. For example, the COVID-19 pandemic accelerated the adoption of telemedicine, leading to a 2900% growth in telehealth claims between 2019 and 2021. It also forced healthcare systems to reconsider how care can be delivered more efficiently and equitably.
As Kuryluk put it, “We saw a correlating decline in patient visits to emergency centres… showing the power of telehealth in managing healthcare efficiencies.”
He emphasized that these trends are global and interconnected. Technologies such as AI and digital health not only address cost and efficiency issues but also expand access to underserved communities—especially when deployed in remote regions.
2. Market Growth and Investor Caution: Opportunity with Selectivity
Despite MedTech’s booming potential—the global industry is expected to surpass $595 billion in annual revenue—investors are becoming more discerning. Kuryluk noted that 2024 marked a significant rebound for venture activity after a volatile 2022–2023 period.
“MedTech investments are growing, but there is focus on investor selectivity. They’re looking for commercialization excellence, strong management, and good financial governance,” he emphasized
The MedTech space is no longer one where every rising startup is guaranteed attention. Investors are now prioritizing ventures with not only novel ideas but also execution plans grounded in market realities. This includes clear roadmaps, market access strategies, and regulatory foresight.
Kuryluk shared that more founders are being asked to prove they have “a single-product focus” and aren’t overly diversified, especially when funding is tight. Investors are wary of startups burning capital across too many verticals without proven success in one.
3. Understanding the Commercialization Pathway
Perhaps the most essential takeaway from Kuryluk’s talk is this: success in MedTech hinges on commercialization. While great ideas are abundant, the companies that win are those that can navigate the maze of engineering, clinical trials, regulatory approval, and market access. He stressed, “Nothing reassures investors more than seeing a company that understands the commercialization process and has strong traction towards demonstrating it.”
He broke down commercialization into several mission-critical workstreams:
- Product development: Engineering a device that meets both clinical and regulatory requirements.
- Clinical validation: Generating evidence to support safety, efficacy, and performance claims.
- Regulatory approval: Navigating approval pathways like the FDA or Health Canada.
- Health economics and outcomes research (HEOR): Building the value story with data that matters to payers.
- Reimbursement planning: Aligning early product development with payer requirements.
- Marketing strategy: Creating a clear go-to-market plan tailored to the healthcare ecosystem.
- Distribution and partnerships: Establishing the infrastructure to reach end users efficiently.
“These commercialization workstreams will dictate whether you have a product or you will have nothing,” stated Kuryluk. He emphasized that startups must engage with these elements early and holistically. Waiting until a product is nearly finished to figure out how to get paid for it—or how to get it approved—can result in delays, added costs, or even failure to launch.
A clear example he provided is the U.S. FDA classification system, which categorizes medical devices based on risk:
- Class I devices (e.g., bandages, manual wheelchairs) are low-risk and often require minimal oversight. They can reach market in as little as 3–6 months.
- Class II devices (e.g., blood pressure monitors, infusion pumps) are moderate-risk and typically require 510(k) clearance, where a startup must show “substantial equivalence” to a predicate device.
- Class III devices (e.g., implantable pacemakers, heart valves) are high-risk, often life-sustaining or life-supporting, and demand extensive clinical trials and full premarket approval (PMA). These can take 3–7 years to reach the market.
Understanding where a device falls in this classification directly impacts time-to-market and cost structure, which in turn affects the startup’s funding needs, exit timeline, and attractiveness to investors.
He explained, “What we may be seeing is a gradual adoption in some cases or rapid adoption in other cases. But you can’t ignore the potential impact… The question becomes: how do you get these technologies accepted, adopted, and operationalized?”
By integrating commercialization workstreams early—particularly regulatory strategy and reimbursement alignment—startups can accelerate timelines, reduce risk, and boost their chances of investor support. For investors, these are the startups that stand out: not just technically sound, but also strategically designed to succeed in the real world.
4. Why Reimbursement Is the Linchpin of MedTech Success
In the MedTech world, regulatory approval is just the beginning. Without a viable reimbursement strategy, even the most groundbreaking products can flounder in the marketplace. Kuryluk underscored that reimbursement—particularly in the U.S.—is both complex and essential: “It’s one thing to have a product approved; it’s another to get traction in the marketplace and achieve your highest potential sales.”
Startups must plan early for how their products will be paid for—by insurers, government agencies, or directly by patients. Kuryluk highlighted that many of the current reimbursement frameworks were developed in the 1960s and have not kept pace with digital or AI-driven tools.
He advised investors to look for companies that incorporate HEOR into their clinical trial design. This not only supports reimbursement negotiations but also enhances pricing strategy and market positioning. Companies that fail to do so often find themselves locked out of key markets.
5. The Power of the Right Team
Kuryluk stressed that team quality is perhaps the most significant indicator of a startup’s potential- “You have to be selfless and make the right decisions for the company, not just the power that comes from leading it.”
He estimated that 40–50% of an investment decision should rest on the strength of the team—especially the CEO, CFO, and Chief Commercialization Officer (CCO). Teams must be transparent, coachable, and mission-driven. Equally important is their ability to pivot and evolve with the company’s growth stage.
He also shared a personal story about stepping down from his role as CEO after six and a half years to care for a family member. At the same time, he recognized that the company needed a new kind of leadership—someone with stronger capital markets experience to guide the next phase of growth. He described the decision as difficult but necessary. For investors, it showed the kind of founder maturity that matters—knowing when to let go for the good of the company and putting long-term success ahead of personal attachment to the CEO role.
6. AI and Disruption: High Potential, High Complexity
AI is one of the most promising yet problematic areas of MedTech. While it offers breakthroughs in diagnostics, surgery, and workflow optimization, regulatory and operational hurdles remain high.
“The promise in these technologies is one thing, but operationalizing them is a completely different matter, “ stated Kuryluk.
Kuryluk pointed out that regulators struggle to keep pace with innovations, especially when AI alters clinical workflows. Even when an algorithm can outperform traditional methods, adoption can stall due to unfamiliarity, risk aversion, or incompatible billing codes.
Moreover, AI systems require vast, high-quality datasets to be effective and safe. Without transparency in training data and validation, these tools face skepticism from clinicians and payers alike.
7. Investor Checklist: What Makes a MedTech Startup Stand Out
Overall, Kuryluk offers a framework for de-risking MedTech investments. Investors should assess:
- Simplicity and scalability of technology
- Strong IP and competitive differentiation
- Clear regulatory and reimbursement pathways
- Operational excellence and visible traction
- Experienced and transparent leadership
“Ask: Why invest in us? And how are we de-risked?”- Nick Kuryluk
Nick Kuryluk’s session delivered a powerful message to angel investors: In MedTech, innovation alone doesn’t guarantee success. What matters is a company’s ability to commercialize, comply, and compete. In a highly regulated industry, mastering the intersection of technology, compliance, and healthcare economics is not just beneficial—it’s essential.
What happens when Canada’s most ambitious tech founders meet the investors ready to back them? Founders and Funders is more than an event, it’s a collection of ideas, capital, and community. It is hosted by Altitude Accelerator, Brampton Angels, Brampton Innovation District, in partnership with City of Brampton. Join us June 11, 2025. Space is limited so register today!
