Insights | DMRY & Co

Insights

Reflections on clinical development, evidence strategy and strategic product development across MedTech, IVD and Health Technology.

Product Development8 min read

Surgeons love coloured buttons

A constructive cross-functional perspective on how small product decisions travel through R&D, Commercial, Regulatory, Clinical and Quality — and why alignment matters early.

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Förstasidan av kommentaren "EU's fragmented early-stage medical device study requirements need reform" i Nature Biomedical Engineering, med karta över nationella krav för Article 82-prövningar i Europa.

Regulatory Strategy9 min readSV

Vad är egentligen poängen med Article 82 om en "other clinical investigation" i Sverige i praktiken möts av krav motsvarande Article 62?

En reflektion om Article 82 i MDR, de svenska nationella kraven och vad de innebär för proportionalitet och förutsägbarhet i tidig klinisk utveckling.

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Overhead view of a cross-functional team collaborating around a round table with notebooks, sticky notes and a tablet during a product strategy workshop.

Product Strategy8 min read

Be Bold. Kill Your Darlings.

Intended Purpose and Claims are often treated as documentation exercises. They're not. They're some of the most important strategic decisions you'll make - and the ones that shape everything that follows.

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Editorial illustration contrasting what early-stage MedTech companies need — strategic decisions, a senior partner, flexibility, someone who challenges assumptions, help prioritising — with what many CROs are built to provide: operational delivery, delivery teams, standardised processes, someone who executes, help producing.

Industry Analysis12 min read

The MedTech CRO Model Was Built for a Different Customer

The value in MedTech consulting is shifting from execution to judgement. The industry's business model hasn't caught up yet.

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Abstract editorial illustration of converging and diverging pathways in navy, cream and gold, suggesting the varied routes medical technologies take into clinical practice.

MedTech Adoption6 min read

Why Some Medical Devices Change Healthcare While Others Never Do

CE marking allows a product to enter the market. Adoption determines whether it becomes part of healthcare.

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Diagram showing how Intended Purpose, Product Claims, Product Development, Risk Management, and Regulatory Strategy connect into Clinical Development Strategy, leading to Clinical Evidence.

Clinical Development Strategy4 min read

Clinical Development Strategy: Connecting Product Decisions to Clinical Evidence

Clinical evidence is the outcome of a series of product decisions. Understanding how those decisions connect is where Clinical Development Strategy begins.

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