When animal study results conflict with the original project plan, a project manager has to prioritize patient safety and long-term device performance over market deadlines. In this case, even though the bio-absorbable stent is technically safe, dissolving too quickly means it fails to meet its intended clinical function. That’s not just a minor issue; it’s a scope problem. The PM would likely need to initiate a design reassessment, update the risk analysis, and communicate transparently with stakeholders about timeline and cost impacts.

This situation affects all parts of the project triangle. The scope may need to change if the material or design requires modification, which will extend timelines and increase costs due to additional testing and regulatory review. Rather than forcing results to align with the business strategy, a strong PM adjusts expectations and bases decisions on data.

Ethically, reducing animal use is critical, but that does not mean repeating studies until results look favourable. At what point does redesign become more responsible than continuing to test? And how should PMs balance investor pressure with scientific integrity?

If the stents fail during in-vivo testing, the team as an entirety would need to re-assess the design. It would be critical to understand why the stents are failing and possible avenues to rectify that. It is also possible that in vitro tests would need to be redone before animal testing is re-visited. The delay would need to be communicated to stakeholders, as Shreya said, and if any FDA documentation needs to be updated, that should be done as well.

I have worked with animal research before, and according to IACUC guidelines, the "Three R's" of animal research are Replacement, Reduction, and Refinement. These guidelines highlight the importance of replacing animal models where possible, reducing the number of animals studied to the minimum, and refining the conditions that the animals live in to minimize stress on their part. The "perfect" scenario would be bypassing the use of animals entirely while still being able to obtain the same information, so these Three R's are things to make concious strides towards. Before being given the go-ahead to use grant money for animal research or for institutional permission, extensive guidelines concerning the number of animals, length of testing, and test/care plans need to be approved. Therefore, the group studying stents would not be able to, on a whim, order more animals to keep conducting tests. They would have to seek permission and prove why it would be clinically necessary to conduct further tests in animals of the failed stents and why it could not be done in a way following the Three R's. In the case of stent failure in vivo, it is most likely that the researchers would do an explant and do a histological examination of the surrounding issue to glean any clues they could rather than continuing tests. In my experience, when an unexpected failure occurs, you terminate animal studies and either put down, release, or re-use the animal (depending on the species and if that animal has been used already for a study). If the animal model being used is more complex (pig/rabbit/primate/etc), the team may switch to a simpler model (mouse/rat) to minimize harm to more intelligent species.

If I were the PM in this situation, I would take the results from the pre-clinical trials and definitely change the plan to address the situation. Continuing without making adjustments to the plan would be irresponsible. The first step I would take is to initiate a formal design review and risk assessment. The dissolution rate is directly connected to the intended use and performance requirements of the device, so reviewing the design inputs and making adjustments would be a good step to take. This affects scope, time, and cost. The scope would be expanded if new materials or a reformulation is needed, time would increase since we would have to do additional pre-clinical trials, and cost would increase with the new research materials. PMs can manage this by meeting with the teams involved and communicating all issues thoroughly. Budgets can be reassigned, but there should also have been some leeway in the budget for situations like this when the project was started. This is where that buffer comes in. Addressing issues such as this early on in this process is much more beneficial than putting a weak bandage on them and continuing, leading to even greater failures down the line. 

There are three options after meeting with the teams and discussing. One is to redesign the stent to adjust the dissolution timing. This would require more clinical trials and more cost. Another solution is to pivot and change the main goal of the stent to be for a shorter-term use case. This would stray away from the original goal, but if this is found to be acceptable, then it would be the most cost-effective. Lastly, the project can be terminated if the core value proposition is no longer viable. This would lead to a lot of money lost. 

The ethical question you pose is complex. You cannot just keep continuing animal tests just to fit the expectations of the data. Statistical analysis needs to be completed to ensure that the least amount of animals are harmed, and new approvals must be obtained. The testing should be stopped early if the endpoints clearly show that the device cannot meet its intended purpose. 

It is clear that data should drive the strategy, and it should not be the other way around. The testing should not be altered so that the desired data is met, so a strong PM would pause and pivot when the data is completely not aligning with the goals of the project. I think there is no point where one should conduct testing until the results fit the desired outcomes without any changes to the test or the product, as one who does the same thing over and over again and expects different results is deemed insane. 

My question is: at what point does a PM recommend terminating a project completely instead of redesigning? What are the objective measures for this? What other teams should be called in to help the PM when deciding whether to end a project or not? 

I think this situation is less about a design flaw and more about the original business assumption being challenged by real data. If the stent dissolves too quickly to provide long-term vessel support, then the product isn’t meeting its intended use, even if it’s technically safe. As PM, I would pause additional animal testing, conduct a root-cause analysis using explant data and modeling, and reassess whether redesign, pivoting the indication, or terminating the project makes the most sense. To answer the question about when to terminate: if redesign would require fundamentally new materials, reset regulatory timelines, and eliminate competitive advantage, the objective measures (NPV, time to market, probability of technical success) may justify stopping. The teams that should be involved in that decision include clinical, regulatory, finance, executive leadership, and ideally an independent scientific advisor to reduce bias. In terms of time, cost, and scope, this likely expands all three, but it’s better to absorb that early than risk a failed clinical program later. Regarding animal ethics, once the study clearly answers the scientific question (that the device cannot meet duration requirements), continuing to test without design changes becomes ethically indefensible. Data should shape strategy, not the other way around, even under investor pressure.

For a Class III bioabsorbable stent, dissolution timing is the value proposition. It dissolving too quickly then it does not meet the customer needs or design input that was actually intended for the device. In this situation, the PM has a responsibility to pause any further advancement of the project to allow the issue to be fully resolved before moving forward again.

Additionally from a PM standpoint, this hits all constraints very easily in terms of scope, time, and cost. The scope of the project expands if material reformulation or polymer chemistry changes are required which may require new bench testing to occur to properly test mechanical properties and biocompatibility, which can push the preclinical timelines created much further down the road, which then ties into the time aspect. By pushing the timelines further down the road for new bench testing, you are pushing back on the overall development process which causes the timeline for the entire project to run longer, increasing the amounts needed for production and reducing profitability, which brings us to cost aspect. As mentioned, additional testing and pushed timelines all have effects on the cost of development for a project and can cause a project to become problematic if too much has to be invested in it for subpar returns. The PM needs to take all of these constraints into account for proper decision gating on metrics like PTS, NPV, and competitive landscape analysis before making decisions on where to redesign, pivot or actually terminate the project. 

On the ethical animal use question, it should be that once the project requires an extension to the duration of the testing without a design change, it becomes ethically unjustifiable. The means for testing shifts from hypothesis testing to data fishing for good results. The use of more animals is only justified in the pursuit of a materially different design hypothesis being test, not simply hoping that the new data obtained will be better aligned towards what you are looking for.

When animal trials provide results that differ from the projects intended goal or business strategy, it is a PM's responsibility to reevaluate the project to fit the findings and not vice versa. Tampering with the results of a study is something that can have major long lasting effects that can harm the company for years to come, as such the PM is responsible for resolving the project in a way that fits both the acquired data and the initial business plan. Now, this will increase costs and time spent on the project, but it is necessary when faced with such a complication. A PM's initial thought should be to report the findings to the research sponsor and see how much more time or funding are allowable for the project and proceed from there. While it may be our ethical responsibility to keep animal testing to a minimum, it is also our ethical responsibility to ensure that whatever products are brought to market are safe and thoroughly tested to ensure that the people who use them are not harmed either.

A new concept that can be discussed is design controls and regulatory documentation and traceability when animal data affects the product's timeline. In a Class III medical device like the bio-absorbable stent, since the dissolution rate can be directly caused by a design input that is correlated to the intended use of the product. There is not only a technical challenge, but also design changes to be made for the design controls. As a project manager one should begin with developing a design control loop which means that the team has to refine design inputs, updated the DHF and ensuring that risk management documentation is reassessed. Making these changes ensures that the project is compliant and that design changes/decisions are traceable for potential review from regulatory. Therefore, if a team continues without updating documentation, it can create a high risk in the future because regulator want data driven design decisions instead of other pressures.

There is another challenge that also arises, even if the medical device is biologically safe if it can't maintain its vessel support during the duration then it fails to meet its purpose. This implies that there is no efficacy in the medical device, the PM has to shift the premise of safety to fulfilling the clinical design purpose. The project scope can potentially need there to be a material reformulation, new degradation modeling and more verification testing before going back to clinical trials with animal studies. Timelines and costs are expected to increase, however it is essential to deliver an efficient device and prevents failure to occur during human trials, which can be more dangerous. In terms of an ethical standpoint on testing with animals, it is important to have the intention to answer and have supportive data to validate clinical studies. If the studies are conclusive and showcase that the design does not meet the required dissolution duration, then repeating the same study will be necessary with no changes. Overall, this can develop into an essential question: Can a PM determine the criteria to a design failure where in development stage if standards are not met it can trigger redesign or a pause to save time and money instead of later?

@aca You raise an interesting issue here, as this is not just a technical setback but a design control and traceability event. With a high risk device like the stent, dissolution rate is not a secondary parameter, due to its direct tie to intended use, clinical performance and risk profile. If the data collected from the animal based trials shows premature degradation of the stent, then it is not just a setback, is becomes a flawed design input. As you mentioned, the PM should create a design control loop to fix the flawed input and document the event properly with the supporting data, as regulators care more about traceability and design decisions than issues with the device timeline. 
Moving to your point about safety vs. efficacy, I think that actually sticking with safety as the primary concern, and efficacy as a secondary could benefit the project better, especially with a Class III device such as the stent. These devices have such high risk with them that teams focusing on efficacy can potentially overlook certain safety risks for the sake of improving the market efficacy of a device. 
Then finally on your point on animal ethics, the only thing that I found myself slightly disagreeing with was the point on justified data with animal testing. If studies are conclusive and show the design does not meet duration requirements, repeating the same study without a design change would not be justified. In this case it becomes data fishing rather than hypothesis testing and becomes ethically unjustified. If you have a different point for your reasoning I would like to hear about it!

As the project manager for a Class I bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with long-term patient needs and clinical performance. Even though the device is safe, dissolving too quickly means it fails its intended purpose, so I would work with R&D, regulatory, and executive stakeholders to reevaluate the design inputs, risk analysis, and business case before moving forward. This situation would clearly impact scope by requiring potential design modifications, time by extending additional preclinical testing, and cost due to redesign and repeat studies, but addressing the issue early prevents larger regulatory or market failures later. I would manage this through transparent communication, formal change control, updated project timelines, and a revised budget forecast. Regarding animal studies, I believe our ethical obligation to reduce animal use must be balanced with generating scientifically valid data; we should not continue testing simply until results “fit” our expectations, but rather redesign the device based on evidence and use alternative methods or refined study designs whenever possible, ensuring that both patient safety and ethical standards remain our priority.

As the project manager for a Class III bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with long-term patient needs and clinical performance. Even though the device is safe, dissolving too quickly means it fails its intended purpose, so I would work with R&D, regulatory, and executive stakeholders to reevaluate the design inputs, risk analysis, and business case before moving forward. This situation would clearly impact scope by requiring potential design modifications, time by extending additional preclinical testing, and cost due to redesign and repeat studies, but addressing the issue early prevents larger regulatory or market failures later. I would manage this through transparent communication, formal change control, updated project timelines and a revised budget forecast. Regarding animal studies, I believe our ethical obligation to reduce animal use must be balanced with generating scientifically valid data; we should not continue testing simply until results “fit” our expectations, but rather redesign the device based on evidence and use alternative methods or refined study designs whenever possible, ensuring that both patient safety and ethical standards remain our priority.

If I were the Project Manager for a Class III bio-absorbable vascular stent and pre-clinical animal data showed the device was safe but dissolved too quickly to provide adequate long-term vessel scaffolding, the first responsibility would be to treat the data as authoritative and immediately reassess the project strategy rather than attempt to force alignment with the original business goal of faster dissolution. In regulated device development, especially for high-risk implants, biology and performance requirements ultimately dictate feasibility; therefore, I would convene R&D, Clinical, Quality, Regulatory, and executive stakeholders to conduct a structured gap analysis and root cause investigation (e.g., degradation kinetics, material composition, strut thickness, polymer chemistry) to determine whether the dissolution profile can be tuned or whether the value proposition itself needs reframing. This directly impacts the project’s triple constraint: scope   may change (e.g., redefine target resorption timeline or reposition the indication), time will extend due to redesign, additional bench testing, and repeat animal studies, and cost will increase because of material reformulation, new prototypes, and expanded verification and pre-clinical work; as PM, I would update the risk register, revise the development plan, create decision gates (continue, pivot, or terminate), and communicate transparently with sponsors about realistic regulatory and clinical implications. Importantly, repeating animal studies simply to “achieve desired outcomes” is both scientifically invalid and ethically unacceptable; under the 3Rs principle (Replacement, Reduction, Refinement), additional animal testing is justified only when there is a scientifically grounded design modification likely to change outcomes, not to chase favorable data. Ethically and regulatorily, the obligation to protect patients and ensure clinical efficacy outweighs business timelines, while the obligation to minimize animal use outweighs attempts to iterate without meaningful design changes; therefore, the appropriate balance is to pause, redesign based on mechanistic understanding, validate changes in vitro where possible, and only re-enter animal studies when there is a clear hypothesis and probability of improved performance.