Market first, regulation in parallel: MedTech World speakers debate evolving pathways to market access

A panel of industry experts at MedTech World Middle East 2026 in Dubai today examined the shifting dynamics of regulatory strategy and market access, concluding that while regulatory compliance remains essential, commercial viability and clinical adoption must lead decision-making.

Moderated by Pilar Fernandez Hermida, the session brought together Dr Amel Havkic (EvoMed Consulting), Shai Policker (Edge Medical Ventures), Denis Losik (eMed Support Systems) and Edwin Lindsay (CS Life Sciences) to discuss how founders should navigate increasingly complex global regulatory environments while ensuring successful market entry.

Market before regulation

Panellists broadly agreed that founders should adopt a “market-first” mindset. While regulatory approval is mandatory in healthcare, speakers emphasised that approval alone does not guarantee commercial success.

“The market should dictate the product,” said Policker, noting that reimbursement pathways, payer readiness and real clinical demand must be assessed early. If barriers to reimbursement or adoption are too high, even a fully approved product may fail commercially.

Dr Amel reinforced this view, arguing that regulatory requirements should be integrated into development, but not allowed to define it. Designing solely to satisfy regulatory criteria risks overlooking practitioner needs and clinical workflow realities.

Regulatory strategy is increasingly geographic

The discussion highlighted significant shifts in global regulatory dynamics.

Historically, Europe was often seen as the preferred first entry point due to CE marking advantages. However, panellists noted that the introduction of MDR and IVDR has made European pathways slower and more fragmented, particularly in relation to reimbursement and health technology assessment (HTA).

In contrast, the US Food and Drug Administration (FDA) was described as increasingly predictable, with structured innovation pathways such as Breakthrough Device Designation offering strategic advantages for qualifying technologies.

The GCC region, including the UAE and Saudi Arabia, was also characterised as rapidly evolving, with regulatory bodies introducing changes aimed at facilitating innovation.

Founders were advised to assess not only regulatory timelines but also local reimbursement structures, distribution channels and demographic considerations before selecting a target market.

Commercialisation and clinical adoption as true endpoints

A recurring theme was that regulatory clearance represents the beginning, not the end, of the journey.

Panellists stressed that clinical adoption is the true measure of success. Without physician uptake, payer support and demonstrable economic value, regulatory approval delivers limited impact.

“Someone has to pay for it,” one speaker noted, underscoring the importance of economic modelling and reimbursement planning from the outset.

Early planning and cross-border clinical strategy

The panel emphasised the importance of early engagement with regulators and strategic clinical trial design. Conducting trials that generate data acceptable across multiple jurisdictions can significantly reduce time to market and capital burn.

Start-ups were encouraged to seek early dialogue with regulatory authorities rather than attempting to anticipate requirements in isolation. Usability testing, increasingly scrutinised by regulators, was also highlighted as a frequently overlooked risk area.

Tactical considerations

Several practical approaches were discussed:

• Exploring FDA Breakthrough designation where applicable

• Considering whether early positioning as a wellness solution may allow initial market traction in certain cases

• Leveraging predicate devices strategically

• Ensuring robust data governance, particularly for software and AI-based products

However, panellists cautioned that attempts to bypass regulation entirely are misguided; instead, companies may sequence functionality to manage regulatory exposure over time.

AI: augmented, not autonomous

The role of artificial intelligence featured prominently in the closing discussion. Speakers framed AI not as a replacement for clinicians, but as “augmented intelligence” designed to enhance decision-making and address workforce shortages.

Regulators remain cautious, particularly around explainability, data integrity and human oversight. Founders incorporating AI were advised to plan early for substantial data requirements and to ensure transparency in algorithmic decision processes.

Decision-making and team execution

Beyond regulatory mechanics, execution discipline was identified as a differentiator. Indecision and over-analysis were described as common causes of start-up failure. Building trusted teams capable of making clear strategic choices was seen as critical to preserving runway and accelerating progress.

Looking ahead

Asked what will distinguish winners in the next five years, panellists pointed to alignment: between clinical need, regulatory strategy, reimbursement planning and commercial execution.

In summary, the discussion reinforced a central message: regulatory approval remains essential, but it is the alignment of market demand, economic viability and clinical adoption that ultimately determines success in MedTech.