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Key-opinion leader (KOL) validation

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: d7bc33aa-1dfc-4e66-916c-0d72ab102213

Service Description

Along the innovative product/solution development pathway relevant go-no-go decisions should be taken into account. To ensure the suitability of the design and/or the product/solution market receptiveness, critical milestones should be checked in early phases to anticipate the health technology optimal launch. By granting the product/solution a KOL validation, by clinical experts through a systematic assessment approach, in a timely manner, will reduce the risk of failing the next steps of the way. IPN, in collaboration with Coimbra University Hospital – Unidade de Saúde Local de Coimbra (ULS-C) and the synergies settled through the TEF-Health partnership, counts on the expertise of high-tier health clinical professionals to provide new technologies assessment in a 3-step way, 1. Preliminary evaluation: the KOL self-assesses the product/solution provided information, to evaluate its medical purpose assumptions? If it answers an unmet medical need? competitor(s) in the market? Strengths/weaknesses of the technology? etc. 2. Short meeting: a 1:1 one-hour meeting, where the KOL is briefed with a 10-15 mins. demonstration of the product/solution, followed by a discussion of the concerning queries. 3. Expert assessment report: a report is issued addressing insight on the raised hot topics, including suitability strengths, weaknesses, opportunities and threats analysis (SWOT) analysis and useful recommendations/ suggestions to be considered.

Offerings: Technological Solutions & Documentation Ethics & Regulatory Affairs Expert Medical Opinion
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Country Portugal
Published Email medicaldevices@ipn.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs 1- Device description and general information. 2- Existing test reports (according to mandatory applicable standards) 3- raw material technical information (if applicable)
Service Outputs Gap Report
Service Standards MDR 2017/745; IVDR 2017/746