MedTech World experts explore the challenges and opportunities in medtech innovation

Industry leaders in medical technology shared insights into the realities of building and scaling medtech companies during a panel at MedTech World Middle East moderated by Sadiqa Siddique, Founder and COO of Intelligent Solutions Discovery. The discussion highlighted the unique challenges of entrepreneurship in healthcare, from regulatory navigation to market adaptation and patient-focused innovation.

The panel featured Dr. Viviana Mucci, CEO of BREA; Andrew Glass, CEO of Vivasure Medical; Yan Lin Lye, Director of Business Development and Commercialisation at IDE Group; Joanna Nathan, CEO and Co-Founder of Prana Surgical; and Steve Gardner, Managing Director of Healthcare World.

Early challenges and founders’ realities

Panelists emphasised that the early stages of a medtech company are often the most precarious. Yan Lin Lye described a common turning point for investors: recognising misalignment among founders or divergent visions for the product. “The moment you realise something has to change—or it won’t work—is when you see the founders going their separate ways,” Yan said.

Dr. Viviana Mucci noted the importance of validation in guiding company decisions. “As a scientist, I rely on validations. Whether small or large, these moments often prompt critical shifts, like rebranding or refining a technology,” she said.

Andrew Glass recounted his experience joining Vivasure Medical, a company he helped take from early-stage challenges to a successful sale for €185 million. “When I joined, the product didn’t work, we had two months of cash, and the founders were in conflict. That was the moment I realised the stakes were high,” he said.

Steve Gardner described the high-pressure environment for entrepreneurs. “If you’re bootstrapping, you have sleepless nights worrying about payroll and cash flow. Every failure is a learning moment, and resilience is key,” he said.

Regulatory processes require ongoing attention

Yan Lin Lye highlighted the critical importance of integrating regulatory compliance throughout product development. “Startups often get their regulatory strategy in place early, whether it’s 510(k), Class II, or de novo,” he explained. “Where they fall down is thinking compliance is just paperwork at the end. Regulatory processes run throughout the entire development lifecycle.”

He outlined three stages of effective compliance: defining requirements, building to meet those requirements, and validating the solution. “Documentation isn’t something to backfill at the end. It must reflect every step. Without it, market entry can take two to three years rather than six months,” Yan said.

Market-specific strategies and global expansion

Panelists discussed the nuances of entering international markets. Andrew Glass noted the distinct regulatory and commercial landscapes across regions, emphasising that strategies effective in one country may not translate elsewhere. “Even within the US, each state has its own regulations and payer models. Understanding local context is key,” he said.

Yan added that tailoring technology to local healthcare ecosystems is critical for adoption. “If you create a solution for a market you don’t fully understand, it may not fit the local system, no matter how innovative it is,” he said.

Innovation, AI, and patient-centric design

The discussion also touched on the growing role of AI in healthcare. Dr. Mucci observed that patient demand often drives adoption, sometimes more than physician preference. “As benefits and risks are assessed, AI integration will increase worldwide,” she said.

Joanna Nathan emphasised the ethical dimension of innovation in healthcare. “Founders must ask themselves whether they would use their technology on someone they love. Safety and speed must be balanced carefully,” she said.

Panelists concluded with advice for entrepreneurs entering the medtech space: immerse yourself in clinical settings, understand local healthcare ecosystems, align solutions with patient and system needs, and ensure personal commitment to the problem being solved.

“Contextualisation, local understanding, and patient focus are the keys to success,” Steve Gardner summarised. “No matter how innovative the technology, it has to solve a real problem for the right people, in the right place, at the right time.”