We bring the manufacturers’ perspective to health research.

We help bridge critical gaps between scientific research, medical product development, preclinical and clinical evidence, regulatory requirements, reimbursement and market adoption.

Our contribution is to help ensure that, at the end of the research project, the consortium has not only generated scientific results but also established the technical, clinical and regulatory foundations needed to continue product development.

Our multidisciplinary expertise is particularly relevant to medical devices, drug-device combination products, biomaterials, implantable technologies, drug delivery systems, AI-enabled healthcare solutions and biotechnology projects requiring preclinical, translational or cross-functional development expertise.

Challenges we can help your consortium solve:

1. Regulatory strategy: We assess the regulatory status of emerging technologies and identify the applicable regulatory framework, including EU MDR/IVDR, SaMD, AI-Act, GDPR and the relevant requirements for combination products. We address device qualification and classification, intended purpose, regulatory pathways, conformity assessment requirements and the implications for product development and evidence generation.

2. Scientific evidence supporting product claims: We help identify critical scientific questions, develop appropriate biomechanical and preclinical models, establish meaningful endpoints and connect experimental findings with clinical and regulatory evidence requirements. We distinguish what the available evidence demonstrates from what still needs to be investigated.

3. Clinical investigation management: We support clinical investigation planning and oversight in accordance with ISO 14155 where applicable, connecting study objectives, investigators, endpoints, evidence requirements, timelines and operational responsibilities.

4. Quality and development processes: We help introduce appropriate design controls, risk management, documentation and traceability into research and development activities. The objective is to ensure that project results can be used effectively in subsequent regulated product development.

5. Reimbursement and HTA: We help incorporate clinical value, reimbursement considerations, economic evidence needs and healthcare adoption into development and exploitation planning..

6. Cross-functional coordination and project execution: We provide PMP-certified project management, taking responsibility for agreed work packages, coordinating multidisciplinary activities, managing dependencies and risks, and delivering defined outcomes. For AI-enabled medical technologies, we connect technical development with clinical applicability, validation, human oversight and regulatory requirements.

Why Biomech Innovations?

Our expertise comes from direct experience in both research and medical product development. We have participated in Horizon 2020 projects and developed a proprietary Class III implantable medical technology from concept through preclinical and clinical evidence generation, EU MDR certification and commercialization, while establishing an ISO 13485-certified medical-device company.

We are particularly relevant to consortia with strong scientific or technological expertise that need additional medical-device development capabilities to translate research results into a practical development plan.