Why MedTech Needs Specialists with Zoltan Kevei and Saby Toth of Bishop & Co

In this episode of the Med Device Cyber Podcast, host Christian Espinosa is joined by Zoltan Kevei, Founder and CEO, and Szabolcs Tóth, a Regulatory and Quality Expert, from Bishop & Co., a Hungarian software and regulatory consultancy specializing in the MedTech industry. The discussion revolves around the complex and evolving landscape of bringing medical software and devices to market, comparing the regulatory environments of the European Union and the United States, and exploring the role of emerging technologies like Artificial Intelligence (AI) in software development.

The guests begin by addressing a major strategic shift in the MedTech industry. Historically, the EU was considered the easier and faster entry point for new medical devices. However, with the implementation of the new, more stringent EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), this has changed dramatically. Tóth explains that these new regulations have created a significant bottleneck, drastically reducing the number of Notified Bodies available for certification and extending approval timelines to anywhere from 9-13 months, sometimes even up to two years. This has led many innovators to pivot their strategy, targeting the more stable and predictable US FDA approval process first, despite the US being a larger and historically more challenging market. They emphasize that navigating this landscape requires deep, specialized expertise, framing the process with the adage, “it takes a village” to successfully bring a product to market.

A significant portion of the conversation focuses on the integration and impact of AI in software engineering. Both guests offer cautionary perspectives, arguing that while AI is a powerful tool, it is not a substitute for human expertise. Tóth uses the compelling analogy of a power drill: it is an excellent tool that makes a carpenter more efficient, but it does not make a novice into a carpenter. Similarly, AI can augment the work of experienced engineers but can lead to significant problems if relied upon without expert oversight. Kevei warns that teams relying too heavily on AI can be led "into the deep forest," producing inefficient or flawed code that costs a great deal of time and money to fix. This underscores the critical importance of keeping a seasoned human expert in the loop to guide development and validate AI-generated work. They also touch on the trend of companies using "AI" as a buzzword to attract investors, which can unnecessarily complicate regulatory pathways and add scrutiny to projects where a simpler, deterministic algorithm would have sufficed. The consensus is that innovators must be diligent and strategic, engaging specialized partners early to manage risk, ensure quality, and navigate the complex journey from concept to market.

Key Takeaways

• The regulatory landscape has shifted, with the new EU MDR/IVDR creating bottlenecks. Many MedTech companies now prioritize entering the more stable US market first, a reversal from previous strategies.

• Artificial Intelligence (AI) is a powerful tool for software development but should not be seen as a replacement for human expertise. It's like a power drill for a carpenter—it enhances efficiency but doesn't create the skill.

• Over-reliance on AI without experienced human oversight can lead to costly mistakes, inefficient code, and significant rework. Keeping an expert in the loop is essential for validation and quality control.

• Bringing a MedTech product to market successfully 'takes a village.' Innovators must collaborate with a team of specialized experts in regulatory affairs, software engineering, and cybersecurity from the project's outset.

• Treating crucial areas like regulatory compliance and cybersecurity as an afterthought is a common but expensive mistake, often leading to major delays and increased costs late in the development cycle.

• The use of "AI" has become a buzzword to attract investors. Companies should be cautious about adding this label, as it can introduce unnecessary regulatory complexity where a simpler algorithm might be more appropriate.

• The MedTech industry requires specialized knowledge. Generalist software developers or regulatory consultants with a hardware focus may not have the nuanced understanding needed for medical software, leading to potential compliance and safety issues.

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