Interview with Doram Elkayam, COO at Obelis Group
To wrap up the year, we are excited to spotlight Doram Elkayam, our COO and one of the driving forces behind Obelis’ growth and direction. From strengthening our operations to shaping how we support clients across medical devices, IVDs, cosmetics and more, Doram has had a front-row view of the challenges and opportunities that defined this year.
In this interview, he shares fresh insights, personal reflections, and a strategic look at what is coming next as we head into 2026.
Q: As a leader at Obelis, how would you describe your personal approach to strategy and decision-making in such a complex regulatory environment?
My approach is centered around clarity, simplification, and direction. Regulation can be extremely complex, and decisions are rarely made in a linear environment. For me, the key is to identify the core drivers of risk, compliance, and commercial value, and then translate them into intentional, actionable priorities. I aim to align our teams, processes, and systems around a shared understanding of why we are doing something—not just what we are doing.
Another important principle is empathy for the client and our service culture vision. Strategy makes sense only if it genuinely supports manufacturers who are trying to deal with uncertainty, evolving legal obligations, and multiple jurisdictional expectations. I put strong emphasis on robustness, but also on flexibility: we build frameworks that allow us to adapt quickly without losing consistency.
Q: Looking back at 2025, what major regulatory or market changes across the medical device sector stood out from Obelis’ perspective?
Though 2025 had no major regulatory deadlines which impact the medical device sector, it felt like a year of consolidation and maturity in medical device regulation. On one hand, the MDR and IVDR continue to stabilize and clarify expectations, but on the other, the ecosystem still faces capacity constraints, long assessment timelines, and fragmentation between markets – for example, when considering the markets we cover as consultants, the EU, UK, Swizterland, the USA and Canada – all these country specific regulations place different requirements and importance over different compliance steps which make compliance a major undertaking for any medical device manufacturer wishing to make its devices available globally. Bridging over these differences is one of the major reasons why working with a group such as Obelis stands out.
Another major trend is and will be the rising role of software and AI in patient care and diagnostics. Regulatory bodies are now much more focused on cybersecurity, clinical evidence, and post-market surveillance for digital health products.
Finally, with an outlook to 2026, there are key regulatory events and deadlines in 2026 which required from us a lot of preparation in 2025 – such as EUDAMED and Swissdamed becoming mandatory, the deadline for IVDR legacy devices, the applicability of the Battery Regulation and more. As a consequence, 2025 was a year of preparation and investment into new structures and systems which will allow us to enhance our capabilities and provide an even smoother compliance process for our customers.
Q: Manufacturers are increasingly aiming for multi-market entry. What do you see as the biggest challenges when entering the EU, UK, US, Switzerland, and Canada simultaneously?
As mentioned above, the greatest challenge is harmonization of expectations. Every jurisdiction asks for documentation, evidence, labelling, and post-market tasks that are similar in principle, but different in form, timing, structure, and responsibility.
Manufacturers underestimate how much resource duplication can arise when each market requires a different review cycle, different legal provisions, and different regulatory hierarchy. Another complexity is sequencing—entering five markets at once sounds efficient, but it can be more resource-intensive than a staggered plan if the documentation isn’t designed with convergence in mind.
From Obelis’ perspective, the technical documentation depth required in Europe often becomes the backbone for other markets, but it needs to be planned from day one.
Q: From Obelis’ position as a key regulatory partner, what practical steps do you recommend to manufacturers who want to streamline documentation and avoid duplication across regions?
First, manufacturers should engage early with partners like Obelis to plan—not only for market approval—but for post-market obligations, vigilance, registration renewals, and lifecycle documentation. The cost of harmonization is lower when it is designed up front.
The second step is to invest in a strong regulatory partner which can offer support across multiple regions. Then, invest in a single master technical file structure that contains the highest level of detail required globally. Of course, every region should derive its own submission package as a “regional adaptation,” rather than starting from scratch.
And third, keep a clear governance structure on document ownership and version control. When five external parties request five different updates, it can easily create inconsistency. A unified regulatory system with change logs, centralized evidence, and coordinated review timelines is essential.
Q: Beyond medical devices, Obelis supports industries such as cosmetics and consumer products. Are you seeing cross-industry regulatory trends that manufacturers should pay attention to in 2026?
Absolutely. The biggest cross-industry trend is the increasing weight of safety substantiation and traceability, especially for products close to the body—medical devices, cosmetics, food supplements, and even smart consumer products.
Authorities are aligning on stronger post-market controls, faster recall expectations, and more transparent documentation pathways. Cybersecurity is another shared theme, especially for connected devices and digital health products.
Environmental responsibility is also shifting from voluntary to mandatory requirements—think chemical restrictions, packaging regulations, and extended producer responsibility for batteries, electronics, or chemicals. Any manufacturer entering Europe in 2026 should expect the regulatory scope to go beyond product safety and include sustainability obligations.
Q: With rapid growth and regulatory shifts, what recent initiatives or improvements within Obelis are you most proud of?
I am proud of how we scaled operational excellence without losing our human connection. We improved our digital processes, strengthened documentation governance, and reinforced client onboarding and lifecycle management tools.
We also invested heavily in internal knowledge, cross-department alignment, and stronger PRRC support frameworks. Our regulatory teams are more synchronized, more specialized, and more prepared to manage multi-market complexity.
But above all, I’m proud of the culture and our service culture: we understood we need to make the regulatory project of our clients our priority, to care and be attentive to their needs and above all, partner with them on an ongoing basis to safeguard their access to the market.
Q: What opportunities for innovation do you see across the industries Obelis serves, and how do you think regulation will shape these opportunities?
Innovation will increasingly sit at the intersection of digital health, preventive care and AI-driven solutions, smart cosmetic devices, and data-powered consumer wellness. Regulation will be a catalyst—not a barrier—because it brings clarity, safety expectations, and validated market access.
I believe the most successful innovators will be those who design products with regulatory strategy built in from the start. A device, formula, or sensor that collects data without cybersecurity safeguards, without clear labeling intent, or without risk documentation or a clear path to market through compliance will face major barriers later. Regulatory foresight has become a business necessity.
Q: On a personal level, what originally drew you into the regulatory field, and how has your experience at Obelis shaped your journey?
What drew me in was the combination of purpose, complexity, and impact. Regulation protects people, and that sense of responsibility appealed to me. At Obelis, I had the opportunity to see how regulatory clarity directly translates into patient safety, commercial success, and international market growth.
My journey inside Obelis has taught me how to balance rigor with pragmatism, how to design scalable structures, and how to support global companies through uncertainty. It’s intellectually challenging and deeply meaningful, and I’m grateful to be shaping the direction of a company that plays a real role in global public health.
Q: Looking ahead to 2026, do you expect global regulatory systems to become more aligned or more fragmented, and how should manufacturers prepare?
I expect a mix of both. Fragmentation will continue in the short term—especially with cybersecurity, environmental regulation, and digital health requirements evolving at different speeds across regions.
However, alignment is happening quietly through shared principles, harmonized evidence expectations, better traceability frameworks, and stronger international cooperation. Full convergence is unlikely soon, but documentation convergence is achievable. Manufacturers should prepare by building regulatory architecture that assumes change, encourages harmonization, and allows efficient adaptation. Those who invest in smart documentation, lifecycle governance, and early strategic planning will have the lowest long-term cost and the fastest multi-market deployment.
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