Technology review & support

Technology review & support

We are always on the look-out for innovative, new diagnostic solutions for poverty-related diseases that we can support on their journey from product development to market access and impact. In particular, we seek diagnostic solutions that meet specific priority needs described by target product profiles, and platform solutions that can be used across several diseases.

 

Support services we may offer for promising solutions include:

  • Advice on precise user requirements and expectations from public health authorities including WHO
  • Technical guidance along the product development path
  • Access to well-characterized samples from our FIND Specimen Bank and other developer toolsets (e.g. strain panels, assay reagents)
  • Support in the conceptualization of appropriate clinical trials and regulatory studies
  • Access to our network of clinical trial sites
  • Advice on approval processes needed to get products into public health markets in low- and middle-income countries
  • Advice on the needs of healthcare delivery systems in low-resource settings

In addition, we have established partnerships between developers, manufacturers and distribution networks, and can also be a partner on grant applications.

Researchers, developers, and manufacturers are invited to submit technology, biomarker and/or product solutions to us for review. Our selection process is designed to be an objective, independent and transparent way to ensure that the most appropriate solutions are supported and potential conflicts of interest are avoided. It includes two stages of analysis. We may also provide support to applicants during this review process.

 

Submit a solution

 

More information

For more information please contact our technology team.

 

Frequently asked questions

Q. Who should submit a solution?

A. Any stakeholder involved in R&D of new diagnostic solutions, technologies, and biomarkers, including in-vitro diagnostic (IVD) companies and academic groups.

 

Q. How can I submit a solution?

A. Please submit your technology, biomarker or product proposal via our online submission form.

 

Q. What type of solution should be submitted?

A. Solutions related to our current strategy will be prioritized. In particular, we seek diagnostics that meet specific, priority needs described by target product profiles, and platform technologies that can be used across several diseases. We are particularly interested in diagnostic solutions that can be commercialized in 3–5 years or less.

 

Q. What makes a successful submission?

A. A submission that results in a fruitful collaboration consists of (i) a technology capable of responding in a timely manner to an unmet need described in a target product profile; (ii) a partner with a strong team having the resources to deliver the solution alone or in a consortium; and (iii) a proposal that clearly describes the envisaged collaboration and relates to our strategic priorities.

 

Q. What happens after I have made a submission?

A. All submissions will receive a response and detailed technical feedback. Potential responses may include:

  • Suitable for potential collaboration and cleared to proceed to an in-depth analysis of the submission
  • No active collaboration identified yet but advice provided to catalyse further development
  • In need of more information
  • Out of scope

 

Q. What types of collaboration can I expect?

A. Following the initial analysis, we may provide basic support such as:

  • Access to reagents
  • Access to specimens
  • Small feasibility studies
  • Diagnostic connectivity guidance

Following the in-depth analysis, we may partner on projects including:

  • Clinical validation studies
  • Data collection for WHO approval or regulatory filing
  • Implementation support (implementation of a diagnostic product in resource-restricted settings, post-regulatory or post-WHO approval)

 

Q. What does an initial analysis evaluate?

A. The initial analysis evaluates elements including:

  • Affordability (cost per test and instrument)
  • Performance (e.g. analytical and diagnostic performance, throughput, time-to-result, hands-on-time)
  • Usability (e.g. system integration, infrastructural requirements, environmental stability, ease of use)
  • Fit with FIND strategy
  • Probability of success (strength of data, team, company resources, technology maturity and time to market)

 

Q. What does an in-depth analysis evaluate?

A. The in-depth analysis is a comprehensive assessment of the strength of the partnership opportunity. This includes:

  • Updated technology status and performance data
  • A detailed assessment of the product or technology concept, including basic market and competitive analysis
  • A detailed risk assessment
  • Partner due diligence (financial, management team, track record)
  • A detailed assessment of fit with FIND portfolio and strategy

 

Q. When is an in-depth analysis required?

A. An in-depth analysis is mandatory in the following cases:

  • FIND support of product development requiring a commitment of >USD 200,000, in cash or in-kind
  • A strategic partnership that commits resources to FIND of >USD 50,000 in cash or in-kind
  • An independent clinical validation study of a prototype or product that involves >300 patients
  • A project that includes data collection for WHO pre-qualification, a WHO policy recommendation, or for submission of a technical file to a recognized regulatory authority
  • FIND support of an implementation project (i.e. post-regulatory or post-WHO approved) requiring a commitment of >USD 200,000

 

Q. Who will review my submission?

A. The initial analysis is carried out by at least two FIND staff members (usually one technology and one disease expert), using a standardized template. It is reviewed and approved by the appropriate programme head. The in-depth analysis is carried out by one FIND staff member, whose analysis is reviewed and approved by the programme head and at least one member of our Senior Management Team. Finally, two members of the Scientific Advisory Committee (SAC) review the partnership opportunity and make a recommendation. The SAC chair oversees the review process and may include other external reviewers.

 

Q. When will I receive an answer?

A. We will acknowledge a submission within 3 days of its receipt. A more detailed reply after completing the initial analysis will typically be sent within 8 weeks from the time of submission. The in-depth analysis will usually occur within 2–3 months, depending on the complexity of the partnership opportunity. The final decision will be communicated as soon as possible thereafter.

 

Q. What is FIND’s policy on conflicts of interest?

A. Any and all potential conflicts of interest are to be declared via our Conflicts of interest and non-disclosure agreement. FIND reviewers will recuse in instances where a possible conflict has been identified. External reviewers have the option to declare conflicting interests for every review separately.

 

Q. Does FIND keep records of my submission?

A. Yes, we archive all submissions in an internal database.

 

Q. Will FIND keep information confidential?

A. FIND treats every submission as confidential and uses the information only for the evaluation and determination (at our sole discretion) of the merit of the partnership opportunity. We usually sign confidentiality agreements prior to the in-depth analysis.

 

Q. What does FIND expect from partners?

A. We are dedicated to ensuring global access to diagnostics. We expect our partners to commit to making products and information, generated through partnership, available at an affordable price, in a sufficient volume, at a level of quality, and in a time frame that benefits people in low- and middle-income countries.

 

Submit a solution


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