How do you assess the feasibility of a new product concept before investing in development?
We evaluate a product concept for technical, regulatory and clinical feasibility, identify show-stoppers and deliver a fact-based foundation for the go/no-go decision. The most expensive mistake is rarely the wrong technology, but the regulatory classification recognized too late: if it only becomes clear after the first prototype that the concept must be classified as a higher-class medical device or as a combination product, the entire requirements profile shifts retroactively.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What determines the feasibility of a new product concept?
Technical, regulatory and clinical feasibility assessment in a single feasibility report · MDR (EU) 2017/745, IVDR (EU) 2017/746, ISO 14971, ISO 10993-1
Last updated: 2026-06-13
A feasibility study clarifies, before actual development begins, whether a concept is technically viable, capable of regulatory approval and clinically demonstrable. Three dimensions have to align, and each one can become a show-stopper on its own:
- Regulatory classification first: whether a concept falls under the MDR (EU) 2017/745, the IVDR (EU) 2017/746 or pharmaceutical law under Directive 2001/83/EC, or touches several regimes as a combination product, determines the entire requirements and evidence profile and should be clarified before any design decision is made.
- Key technical risks: materials, mechanics, electronics and software determine fundamental feasibility; for body-contacting medical devices, the biological evaluation under ISO 10993-1 belongs in the assessment early.
- Clinical evidence requirements: which clinical evidence approval demands, and whether it must be provided through existing literature or through dedicated studies, decisively determines the time and resources the later development will require.
- Risk-based assessment: the identification and prioritization of the key risks follows the logic of risk management under ISO 14971 and makes visible which uncertainties must be resolved before a development commitment.
- Go/no-go criteria: without decision criteria defined in advance, the feasibility question gets answered optimistically in business plans instead of being measured against verifiable thresholds.
Services
How we support you
Technical Feasibility Assessment
Assessment of the key technical risks across materials, mechanics, electronics, software and biocompatibility under ISO 10993-1. The result is a documented list of critical uncertainties and show-stoppers with a recommendation of concrete go/no-go criteria for further development.
Regulatory Feasibility Assessment
Early classification of the concept under the MDR (EU) 2017/745, the IVDR (EU) 2017/746 or pharmaceutical law under Directive 2001/83/EC, including the demarcation of combination products. The deliverable is a regulatory roadmap with the conformity assessment route and show-stoppers identified before development.
Clinical Feasibility Assessment
Assessment of the clinical evidence requirements and the available literature base, plus an evaluation of the feasibility of clinical endpoints. Delivers a reasoned recommendation on the need for clinical studies, including first-in-man decisions.
Feasibility Report & Go/No-Go Decision
Consolidated feasibility report with a structured risk assessment across all three dimensions and a documented go/no-go recommendation supported by fact-based reasoning for management and investors.
How we work together
What it comes down to
A feasibility study answers three questions in a specific order, and that order is itself the lever. First comes the regulatory classification: whether a concept falls under the MDR (EU) 2017/745, the IVDR (EU) 2017/746 or pharmaceutical law under Directive 2001/83/EC, or whether it touches several regimes as a combination product, frames everything that follows. Only on that basis can the key technical risks be assessed meaningfully, because classification and evidence obligations determine which material properties, which software requirements and which biological evaluation under ISO 10993-1 are relevant in the first place. Last comes the clinical evidence requirement, which cannot be assessed reliably without the regulatory framing.
The bottleneck almost always arises where this order is broken. If development comes first and classification only afterward, design decisions have already been made by the time the regulatory requirements become visible, and they have to be revised retroactively. This is exactly what makes a structured assessment valuable: it pulls the expensive findings forward, prioritizes the key risks according to the logic of risk management under ISO 14971, and tests them against go/no-go criteria defined in advance before development budget is committed. The result is not an optimistic assumption in the business plan, but a decision measured against verifiable thresholds.
Our approach
Our approach
Step
Result
Concept and target-profile intake
Documented description of the product concept, the intended purpose and the feasibility questions to be answered.
Regulatory classification
Confirmed regulatory regime (MDR, IVDR or medicinal product), conformity assessment route and identified regulatory show-stoppers.
Technical risk assessment
Prioritized list of key technical risks, including biocompatibility under ISO 10993-1 and critical uncertainties.
Clinical evidence assessment
Assessed clinical evidence requirements and a recommendation on the need for studies, including first-in-man.
Feasibility report & recommendation
Consolidated report with risk assessment and a documented go/no-go recommendation including reasoning.
Common pitfalls
Where projects commonly fail
Regulatory classification is deferred to later.
If it only emerges after the first prototype that the concept falls under the MDR (EU) 2017/745 or the IVDR (EU) 2017/746 in a higher class, the requirements profile changes retroactively and design decisions have to be revised.
Combination products are thought of one-dimensionally.
A concept that combines a medicinal product under Directive 2001/83/EC with a medical device touches two regimes at once; if only one is considered, entire blocks of requirements are missing from the feasibility assessment.
Biocompatibility is treated as a detail.
For body-contacting products, the biological evaluation under ISO 10993-1 can turn a material into a show-stopper; if it is only assessed during development, material decisions have already been made.
The clinical evidence requirement is underestimated.
If it is assumed that existing literature suffices, and a need for dedicated clinical data later emerges, there is no time left for it, and the business plan rests on an overly optimistic assumption.
No go/no-go criteria are defined before the assessment.
Without thresholds set in advance, the result becomes open to interpretation, and a concept is developed further even though its feasibility has not been demonstrated.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): primary text
- Regulation (EU) 2017/746 (IVDR): primary text
- Directive 2001/83/EC: Community code relating to medicinal products for human use
- ISO 14971: Application of risk management to medical devices
- ISO 10993-1: Biological evaluation of medical devices
- Source material: writer page Feasibility Studies (2026-03-29)
- https://theentourage.de/expertise/feasibility-studies/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- Directive 2001/83/EC (medicinal products for human use)
- ISO 14971 (risk management for medical devices)
- ISO 10993-1 (biological evaluation of medical devices)
Related topics
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