Evaluate a Preclinical Partner Through a First-In-Human Lens

1. Do you have experience in my therapeutic area and device category?

Why it matters

Therapeutic-area and device-category experience affect whether a partner can anticipate the clinical realities your device will face and the currency of the regulatory environment. A team without that fluency may produce a study that satisfies the submission while missing the questions that matter most at first-in-human trials.

Strong answer

• Specific prior programs in your therapeutic area and device category, named where confidentiality permits.
• Familiarity with the clinical workflow your device is intended to enter, not just the preclinical procedure.
• A track record across the device class, not a single or loosely comparable program.

What should give you pause

• General large-animal capability presented as category expertise.
• Claims of equivalence to your device class without published validation or strong, verifiable demonstration of prior work.
• Limited experience with your specific procedure or device type.

2. How many veterinary techs and surgeons do you have for interventional work, and how long have they been doing it?

Why it matters

Interventional studies depend on the depth and tenure of the surgical and technical team. Procedural fidelity, recovery management, and data integrity all depend on people who have done the work repeatedly; thin teams or inexperienced operators can introduce variability that may not be obvious in the final report but can show up quickly in human cases.

Strong answer

• A named team with veterinary surgeons whose tenure is measured in years, not months.
• Procedural volume across the device class.
• Continuity between the team that scopes the study and the team that performs it.

What should give you pause

• Vague answers about team size or tenure.
• Heavy reliance on contractors or visiting surgeons for the procedure type.
• Inability to name the surgeon who will lead your study.

3. Have you helped sponsors generate publication-quality data, publishable methods, or sponsor-facing evidence packages?

Why it matters

Publication-quality preclinical data suggests both methodological rigor and an understanding that preclinical evidence has value beyond the submission. For sponsors planning to publish, present, support KOL engagement, or build downstream evidence packages, that experience matters.

Strong answer

• Examples of peer-reviewed publications co-authored with sponsors.
• Familiarity with editorial and methodological standards in your therapeutic area.
• A study design discussion that considers how endpoints will read in a manuscript, not just in a submission.

What should give you pause

• No publication record, or only conference posters.
• Reluctance to discuss study design in terms of external readability.

4. Have you supported KOL involvement in study design?

Why it matters

KOL involvement in preclinical design is one of the clearest signals that a partner is thinking about clinical translation from the start. Clinicians who will eventually use or evaluate the device bring procedural, workflow, and credibility considerations that a purely preclinical team will not surface on its own.

Strong answer

• A documented process for incorporating KOL input into study protocols.
• Examples where KOL involvement shaped procedural design, endpoint selection, or facility setup.
• Comfort facilitating KOL observation or participation in the preclinical procedure.

What should give you pause

• KOL involvement framed only as post-study advisory.
• No examples where KOL input changed the study design.

5. How do you determine whether an animal model is appropriate for the intended clinical indication and endpoints?

Why it matters

Model selection is not a question of whether a model can work. It is a question of whether it can support meaningful evaluation of the predefined endpoints and anticipated clinical risks.

Strong answer

• A structured rationale grounded in anatomic and physiological comparability for the specific structures the device interacts with.
• Specificity about which features of the model are critical, such as vessel diameter, wall thickness, or chamber dimensions, and why.
• A recommendation that explains both why the chosen model is appropriate and why alternatives were ruled out.

What should give you pause

• Generic appeals to close-enough anatomy without specifics.
• A default-model approach that does not vary meaningfully across device categories.
• Inability to articulate the anatomic constraints that will most affect device behavior.

6. If the model is new or custom, how many similar models have you developed and what is your validation approach?

Why it matters

Where no predicate model exists, the rigor of model development becomes part of the study’s credibility. A partner developing a model for the first time, without a validation framework, introduces risk that may not be visible until regulators or reviewers question the translational relevance.

Strong answer

• A track record of developing models where no predicate exists.
• A documented validation approach, ideally with peer-reviewed or published support.
• Refinement of models through collaboration with surgeons, imaging, and real-world device constraints.

What should give you pause

• Claims of model equivalence without published validation or prior work.
• A retrofit approach: adapting a general large-animal setup rather than developing for the specific clinical question.

7. How are pathology endpoints selected and justified? How do you ensure they support clinical claims?

Why it matters

Pathology is not just slide reading. It is the layer of evidence that often determines whether a safety story holds up under regulatory and clinical scrutiny. Pathology endpoints chosen without reference to the eventual clinical claim leave gaps that surface late.

Strong answer

• Tenured veterinary pathologists who understand the end-to-end device development pathway.
• In-house, integrated pathology operations rather than outsourced slide reads.
• A process for selecting pathology endpoints that explicitly considers the clinical claim the data will support.

What should give you pause

• Pathology treated as a downstream service rather than an integrated study design input.
• Limited pathology continuity across the program.

8. Can you support simulated clinical workflows?

Why it matters

Procedural intelligence, including how long the procedure takes, what the team needs in the room, and where usability issues emerge, only comes from a study designed to mirror the clinical setting. A study that does not simulate the clinical workflow will not surface the questions that matter at first-in-human.

Strong answer

• Facility configurations that mirror the intended clinical setting, including imaging, hemodynamic monitoring, console placement, and staffing.
• Examples where workflow observations changed downstream clinical or training plans.
• Comfort designing the study around procedural realism, not just safety endpoints.

What should give you pause

• A facility setup notably different from the intended clinical setting.
• Workflow simulation treated as optional or as an upcharge rather than as central to study value.

9. How do you incorporate usability or procedural observations into study design?

Why it matters

Usability and procedural insights captured in the preclinical phase reduce the learning curve at first-in-human. Captured well, they inform investigator training, site readiness, and the predictability of the early clinical experience. Captured poorly or not at all, they surface in human cases as technique problems, operator uncertainty, and avoidable concerns about device performance.

Strong answer

• A documented method for capturing usability and procedural observations during the study.
• Output structured for use in training, IFU development, and site readiness, not buried in narrative.
• Coordination with human factors expertise where appropriate.

What should give you pause

• Usability observations treated as informal anecdote.
• No defined process for translating procedural observations into downstream deliverables.

10. How do you define study objectives, endpoints, and analyses to support both regulatory needs and clinical translation?

Why it matters

This question most directly tests whether a partner sees the study as a regulatory deliverable or as the foundation for first-in-human readiness. The answer reveals their orientation more clearly than any other.

Strong answer

• Endpoints justified on both regulatory and clinical-translation grounds.
• Explicit consideration of what the data will be used for after submission, including investigator training, site readiness, KOL engagement, and reimbursement evidence.
• Willingness to discuss tradeoffs where regulatory and clinical-translation interests diverge.

What should give you pause

• Endpoints justified purely by regulatory precedent.
• Difficulty articulating downstream uses of the data.

11. How do you approach worst-case condition testing?

Why it matters

Investigators at first-in-human need to know how the device behaves under clinically relevant worst-case conditions and what to do when those conditions occur. A study that does not pressure-test those conditions leaves knowledge to be acquired in human cases.

Strong answer

• A structured approach to identifying clinically relevant worst-case conditions before study design is locked.
• Explicit incorporation of those conditions into the protocol where appropriate.
• Output that informs investigator training on what to expect and how to respond.

What should give you pause

• Worst-case testing treated as an add-on rather than a design input.
• Inability to articulate which worst-case conditions are most relevant to your device.

12. How do you treat safety and device performance in the study design? Are they separate or intertwined?

Why it matters

Safety and performance are often discussed as separate endpoints, but for a sponsor preparing for first-in-human they are inseparable. A partner who designs them in isolation will produce a report that satisfies GLP and leaves the sponsor without the integrated picture clinicians and reviewers need.

Strong answer

• A study design in which safety and performance endpoints are designed together and analyzed in relation to one another.
• A clear articulation of where the two interact in the clinical context.

What should give you pause

• A design that treats safety and performance as parallel but unrelated tracks.

13. How do you determine appropriate recovery periods and timepoints?

Why it matters

Recovery periods and timepoints determine what the study can demonstrate about the device’s behavior over the clinically relevant horizon. Choices made here are often not revisited, and they constrain what the data can support.

Strong answer

• Recovery and post-operative management plans with depth and specificity.
• Timepoints justified against the clinical question and the device’s intended use horizon.
• Capability to support long-term survival or degradation studies where the clinical question requires it.

What should give you pause

• Default recovery timelines applied across device categories.
• Inability to support chronic endpoints where the device’s clinical use requires them.

14. How do you ensure endpoints align with anticipated clinical risks?

Why it matters

Endpoints that do not map to anticipated clinical risks leave the sponsor with a report that may satisfy regulators but does not address the questions investigators and reviewers will ask. The alignment between endpoint and risk is a clinical-translation test, not a regulatory one.

Strong answer

• A risk-anchored process for endpoint selection that begins with the anticipated clinical risks of the device in use.
• Endpoints that can be traced back to specific clinical concerns.
• Willingness to add or refine endpoints where clinical risk analysis identifies gaps.

What should give you pause

• Endpoints derived primarily from prior protocols rather than from current clinical risk analysis.

15. How do you help sponsors generate data useful for physician adoption?

Why it matters

Preclinical work designed only for the submission produces a final report. Preclinical work designed with adoption in mind also produces evidence physicians care about: procedural simplicity, ease of learning, reproducibility, predictability, and complication management. That evidence becomes powerful when investigators and adopters are evaluating the device.

Strong answer

• A design conversation that includes which adoption-relevant variables will be captured and how.
• Output structured to be used in physician engagement, not just in submissions.
• Coordination with commercialization, reimbursement, or KOL teams where appropriate.

What should give you pause

• Adoption framed as a post-approval consideration.
• No process for capturing adoption-relevant variables during the preclinical study.

16. How do you design studies that satisfy GLP requirements and reduce risk for first-in-human adoption and downstream commercialization?

Why it matters

This is the summary question. It tests whether everything above is connected. A partner who can answer it well has thought about the study as part of a larger pathway, not as an isolated event.

Strong answer

• An articulated view of GLP as part of a preclinical-to-clinical pathway, not as a terminal milestone.
• A study design philosophy that explicitly considers first-in-human readiness, site adoption, and commercialization-relevant evidence.
• Continuity or close coordination between the partner’s preclinical and clinical functions.

What should give you pause

• GLP described in isolation, without reference to what comes after.
• A handoff model in which preclinical findings are not visibly informing clinical planning.