CQM supports MedTech and BioTech organisations in bringing medical innovations to market faster, more reliably, and with solid evidence. We combine statistics, data science and mathematical modelling with deep domain expertise in medical technology and biotechnology
Innovation in MedTech and BioTech under high pressure
The Netherlands has a strong ecosystem in MedTech and BioTech. From medical technologies that help keep healthcare accessible and affordable, to biotechnological innovations that enable more effective treatments, ambitions are high.
At the same time, many MedTech and BioTech companies operate in a context of high complexity and strict regulation. Start-ups and scale-ups work with limited time, budgets and capacity, while early-stage decisions have major consequences for clinical validation, regulatory approval and scaling up.
Questions we frequently see in MedTech and BioTech organisations
In our work with MedTech and BioTech clients, we often encounter questions such as:
- How do we statistically substantiate design and validation choices?
- When are our data and analyses strong enough for European and international regulators?
- How do we design clinical studies that are both robust and efficient?
- Where do we risk delays, rework or rejection?
- When do we need additional data science or biostatistical expertise?
These questions typically arise at moments when decisions have a major impact on timelines, budgets and eventual market entry.
How CQM supports MedTech and BioTech teams
CQM supports MedTech and BioTech organisations with in-depth expertise in statistics, biostatistics and data science. Not as a stand-alone advisor, but as a substantive partner working alongside teams throughout development and validation.
When you engage CQM, you gain access not to a single expert, but to a team of experienced mathematical consultants with broad experience in medical and biotechnological applications. Our expertise includes, among others:
- Embedded analytics in medical technology
Modern MedTech and BioTech products increasingly rely on digital intelligence. We support the development, analysis and validation of algorithms for sensor data, diagnostics and therapy optimisation, ensuring they function reliably and are statistically well substantiated.
- Clinical validation and biostatistics
Market approval requires convincing evidence. CQM supports the design of clinical studies and the statistical analysis of data. Our accredited biostatisticians provide analyses that meet regulatory requirements and withstand audits.
- Product development and scale-up
Statistics remain critical beyond clinical validation. We support tolerance analysis, product verification and optimisation, enabling products to be manufactured reproducibly, reliably and cost-effectively.
What does a data-driven approach deliver?
A well-founded, data-driven approach helps MedTech and BioTech organisations to:
- Achieve technical and clinical milestones faster and with greater confidence;
- Identify and manage risks at an early stage;
- Prevent delays and rework in clinical programmes;
- Build trust with regulators, partners and investors.
Organisations that lack this level of substantiation face an increased risk of costly delays, additional expenses or the need to repeat studies.
Want to learn more about support in MedTech & BioTech?
Are you facing critical decisions in product development, clinical validation or data analysis?
Get in touch with Wim and discover how CQM can strengthen your MedTech or BioTech team with statistical and data-driven expertise.
