HRC Technology Assessment Form

Technology Assessment Form
Company/Organisation:
Name of Technology
Full Name:

First NameLast Name
Job Title:
Sector:
Email:
example@example.com
Company Website:
Country
- Countries of Incorporation
- Company Team (e.g. number of employees and positions)
- Product Portfolio
- Previous experience in HealthTech/MedTech/Diagnostic development and therapeutic areas of focus
- Research Theme Requested:
- Do you require a Non-disclosure agreement (NDA) to be signed?
- The goal of this section is to review the following:
  - Opportunity and prioritisation of targeted therapeutic area
  - Standard of care analysis by potential target market
  - Unmet needs analysis
  - Pipeline and broader market competitive analysis
  - Reimbursement planning and market prioritisation
- What are the specific indications for the technology?
- Who are the target patients/patient population/demographics?
- What anatomical sites does the technology target?
- What healthcare problem does this technology solve? What is the impact on medical/patient outcomes?
- Where (e.g. home, clinic, hospital) will the technology be used?
- Describe the healthcare practitioners who will use this technology?
- What other/alternative standard of care/products/devices are currently used and available to patients?
- What countries, jurisdictions and regions are the intended markets for this technology?
- This section will review the following:
  - assessment of privacy and compliance requirements based on jurisdictions
  - review of predictive value
  - validation assessments
  - competitor and pipeline of alternatives analyses
  - market sizing analysis, including market access and reimbursement planning and market prioritisation
- What is device or other classification?
- Is this a new technology or is the technology fundamentally similar to a predicate device?
- What components make up the device? e.g. AI, ML, Implant, Stent, Software, etc
- Does the device include software?
- What are the key design features?
- Are any additional devices required to achieve the desired clinical outcome?
- What validation testing has been done? If not, what testing is planned?
- YesNoOther
- What conditions would put the patient in a situation where the risk of your technology would outweigh the benefit?
- How do the contraindications compare with current devices or treatments for the intended use?
- Will your technology need to be sterile? If yes, how will sterility be achieved and confirmed?
- Have the toxicology profiles of the component parts of your technology been reported?
- Will any additional toxicology tests be required?
- Will animal models for efficacy and safety be required prior to treating patients?
- What are the possible consequences of failure of the technology?
- How will the device be tested for robustness and safety?
- What is the clinical evidence to support the indication for use?
- What is the safety profile?
- What is your plan to obtain regulatory approval for the intended markets?
- What research is planned (e.g. trials, case reports, real world evidence)
- How will the endpoints in the study support the competitive positioning and marketing strategy for the new device?
- What finances have you received to date to support your technology discovery, development and R&D?
- What is the market size for each country/region you are targeting?
- Is there an opportunity or plan for early revenue?
- What is the anticipated product life cycle?
- How much is the anticipated cost to complete R&D?
- DisabilityGender reassignmentMarriage or civil partnershipPregnancy and maternityEthnicityReligion or beliefSexual orientationSex (gender)Age
- Please explain and give examples of any evidence/data used?
- What actions do you intend to take to address the negative impacts?
- Is it possible that the technology could discriminate or unfairly disadvantage a group of people?
- Validation of unmet clinical need (i.e. access to clinical expertise)Conduct validation/evaluation (e.g. proof-of-concept, feasibility studies)Methodology/Statistical support for clinical trials and/or health economicsHealthTech Focus Groups with patients (i.e. patient and public involvement)Access to industry and/or academic partnersAccess to research sites and patient recruitsAccess to biobanks and/or labsEnd User Testing or Prototype TestingProduct development adviceRegulatory adviceMarket access adviceSustainability support, evaluation or adviceGrant funding collaborationOther
- Thank you for taking the time to answer these questions.
- Email
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