Research & Development
Feasibility studies.
Identify risks early and allocate resources strategically. We conduct technical, regulatory, and clinical feasibility assessments for new medical devices—ensuring your development is built on a solid foundation.
Why are feasibility studies the critical first step?
Investments in the wrong direction can be extremely costly in medtech development:
- Technical feasibility is assumed without first conducting a systematic assessment of specific key risks.
- Regulatory classification is not researched until late in the process—with drastic consequences for design and time-to-market.
- Without a thorough analysis of the evidence, clinical need and market potential are often greatly overestimated in business plans.
- The lack of feasibility studies often leads to "pivot" situations only after significant initial investments have been made.
Have you made a structured go/no-go decision based on real data for the next phase of your product development?
Our feasibility study services.
We evaluate your product concepts across three key areas: technical, regulatory, and clinical.
Technical Feasibility Assessment
Assessment of key technical risks such as materials, mechanics, electronics, software, and biocompatibility. Early identification of show-stoppers to avoid dead ends in development.
Regulatory Feasibility Assessment
Strategic classification of the concept (MDR, IVDR, combination product). Early assessment of the certification pathway and identification of regulatory "hurdles" before the actual project launch.
Clinical Feasibility Assessment
Assessment of evidence requirements and the literature base. Realistic assessment of the need for clinical trials, as well as the design and conduct of clinical feasibility studies for first-in-human decisions.
Feasibility Report & Go/No-Go Decision
A comprehensive report featuring a structured risk assessment. We provide a fact-based rationale for your investors, management, and the final go/no-go decision.
Frequently Asked Questions About Feasibility Studies.
When exactly should a feasibility study be conducted?
This is essential prior to any major investment in development: for entirely new concepts, for expanding existing product lines into new indications, for technology changes (e.g., new materials), or for entering markets with stricter regulations (e.g., expansion into the U.S.).
What is the difference between a clinical feasibility study and a pivotal study?
A clinical feasibility study (often a first-in-human study) is purely exploratory: it assesses basic feasibility and primary safety, and provides initial evidence of efficacy in a small cohort. The pivotal study is the formal, large-scale main study with sufficient statistical power to support final approval.
What costs and time frame should you expect?
That depends heavily on the scope of the project. A purely regulatory, literature-based feasibility assessment can often be completed in a matter of weeks. A technical or clinical feasibility study, including early prototypes and human subjects, requires significantly more time and funding.
Can ENTOURAGE also provide data support for investor pitches?
Absolutely. An independent, well-structured feasibility report with a clear regulatory roadmap significantly reduces risk in the eyes of investors. We also actively assist with the preparation of technical and regulatory due diligence documents.
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