Pharma
- What applies
- Directive 2001/83/EC sets the frame for medicinal products for human use.
What do feasibility studies deliver when the viability of a new product concept has to be settled before you invest in development?
We assess a product concept in Feasibility Studies for technical, regulatory and clinical feasibility, identify show-stoppers and deliver the basis for the go/no-go decision. If it emerges only after the first prototype that the concept is a higher class or a combination product, the requirement profile shifts retroactively.
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: September 18, 2026
A feasibility study clarifies, before actual development begins, whether a concept is technically viable, capable of regulatory approval and clinically demonstrable.
- 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 clarifies 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.
Industries
What this means in your industry
Biotech
- What applies
- Directive 2001/83/EC applies here as in pharma.
MedTech
- What applies
- MDR (EU) 2017/745 sets the frame; ISO 14971 governs risk management, ISO 10993-1 the biological evaluation.
IVD
- What applies
- IVDR (EU) 2017/746 sets the frame for in vitro diagnostics.
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 works through classification, technical risks and clinical evidence in that order, and the first step already narrows the other two. 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.
In nearly every case, the bottleneck 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.
A structured assessment 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
01
Concept and target-profile intake
Documented description of the product concept, the intended purpose and the feasibility questions to be answered.
02
Regulatory classification
Confirmed regulatory regime (MDR, IVDR or medicinal product), conformity assessment route and identified regulatory show-stoppers.
03
Technical risk assessment
Prioritized list of key technical risks, including biocompatibility under ISO 10993-1 and critical uncertainties.
04
Clinical evidence assessment
Assessed clinical evidence requirements and a recommendation on the need for studies, including first-in-man.
05
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.
Product Development & Regulatory Strategy
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Before any significant development investment: for new product concepts, when extending existing product lines into new indications, for new materials or manufacturing technologies, and ahead of planned market entries into new regulatory environments under the MDR (EU) 2017/745 or the IVDR (EU) 2017/746. The earlier feasibility is clarified, the cheaper the consequences of a concept change.
A clinical feasibility study (first-in-man) is exploratory in nature: it assesses fundamental feasibility, safety and first indications of effectiveness. A pivotal study is the confirmatory main study for approval, with defined statistical endpoints and a sufficient sample size, and provides the robust clinical evidence for the regulatory assessment.
It is the first lever. Whether a concept falls under the MDR (EU) 2017/745, the IVDR (EU) 2017/746 or pharmaceutical law under Directive 2001/83/EC determines classification, conformity assessment route and evidence obligations. This classification should be settled before technical and clinical aspects are assessed, because it frames their requirements.
Yes. Structured feasibility reports with a documented risk assessment and a regulatory roadmap are robust arguments in investor decisions. We prepare the basis for technical and regulatory due diligence on a fact-based footing, without making assumptions beyond the available evidence.
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
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Latest 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
Design Controls →
From the feasibility result into structured development
Prototyping →
Testing technical feasibility through early prototypes
Clinical & Medical Affairs →
Going deeper on clinical evidence requirements and study planning
MDR Conformity →
Regulatory positioning of new concepts under EU 2017/745
Have a concrete project?
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