Table of Contents
- Medical Device Prototype Stage
- Market and End-User Insights
- Building a Strategic Product Development Plan
- Streamline the Regulatory Path
- Alternatives to Costly Preclinical Animal Studies in Early Prototyping
- Optimizing Study Size and Animal Model Selection
- Keeping Preclinical Studies Simple and Focused
- Aligning Study Goals with Product Development Objectives
- GLP vs Non-GLP Studies
- The Value of Experienced Teams and Labs
- Avoiding Costly Milestone-Driven Mistakes
- Knowing When to Pivot: Letting Go of Bad Ideas
- Material Choices
- Summary
- Frequently Asked Questions (FAQs)
The development of new medical devices is a complicated endeavor that requires innovation, creativity, experience, regulatory guidance, and of course money. Every inventor and entrepreneur who has undergone the full development from concept to patient use of a medical device understands the pressures of having to fund their project or company, or face having to prematurely stop working on a product before it reaches maturity and the market. Having seen many projects over decades, we have watched the unfortunate and often predictable results of companies who spend their money unwisely and find themselves stuck with the need for more venture capital at best or, at worst, having to close the project due to insufficient funds. Generally, it is easier to see from an external viewpoint when a company is deviates from good product development practices. This can be a concerning predictor of potential failure. It is easy to become too close to a product, losing sight of the bigger picture and what is actually important for your end goals.
On the contrary, there are certain successful habits we have seen that medical device entrepreneurs and product developers follow which increase the odds of success. In this article we will share some of the strategies for preclinical medical device prototype testing that companies use to stretch their dollars, minimize development time, and help increase the odds of a successful product launch without wasting the precious capital they have raised along the way.
Medical Device Prototype Stage
At the medical device prototype stage, the R&D stage is past, and early medical device prototypes are available for a new medical product. Early preclinical animal work is often aimed at:
- Obtaining efficacy proof of concept data for raising capital
- Publications
- Refining the device design
- Optimizing the animal model and/or implantation techniques
- Early understanding of device-tissue interactions and screening for biological response
- Performing pilot work to test safety and performance in preparation for GLP safety and performance studies
Each of these goals may involve different endpoints for achieving the objectives of the study and getting the data needed to move forward. It can sometimes be a painful process and very expensive depending on the device type. With good planning, optimizing the approach, and avoiding common mistakes and traps, medical device product developers can achieve the best odds of stretching their budgets and maximizing the dollars spent to achieve the most useful data for their product to move forward. Seasoned medical device product developers will likely recognize the tips, tricks, and potential traps discussed below. If you are new to the field, hopefully the strategies and potential mistakes outlined will help make device development a little easier.
Start with the End in Mind: Market and End-User Insights
- Understand the market for the product. Too many times, we find entrepreneurs misinformed of the value proposition for their products. Understanding the competition, reimbursement landscape, patient need, and provider perspective will help greatly in the success of the product’s development.
- Get input from KOL’s and experts on the readiness of medical device prototypes. Many times, a simple examination of devices by knowledgeable experts such as physician users and experienced medical device developers can find flaws and issues that can be solved before use in expensive preclinical animal studies.
- Feedback from health care providers who are the planned end users will help avoid costly mistakes that might hinder market adoption and will also help ensure the device design meets their expectations. There is a reason why it is called “bench to bedside”. The key is to not simply jump the product from the bench without first paying close attention to the clinical patient’s needs. Devices that do not have the end user in mind are destined for failure from lack of funding, user acceptance, and reimbursement.
- Consult physicians, nurses, reimbursement specialists, and other end users of the device and ensure you keep them close throughout the product development process. They are a highly valuable resource to help product developers focus on the ultimate clinical needs of their device and design of medical device prototypes that will be successful.
Building a Strategic Product Development Plan
Once past the R&D phase, when there is a medical device prototype with feasible efficacy, put together a product development plan for your entire product development testing. Many well-organized medical device entrepreneurs start with this effort even at the R&D stage. It is important for business planning and understanding the path needed for medical product development.
- Involve an experienced regulatory team in the device space.
- Use literature and previously cleared products to help inform the overall product development plan. This can sometimes be difficult in the early stages, but as a medical device prototype becomes clear, it is time to determine its clinical indications for use and compare it to other products on the market.
- Regulatory submission of data from other predicates can help inform the path. Evaluate competitive devices closely and early in the product development cycle and try to understand the regulatory path that cleared products have taken.
- Define the device classification to know if clinical trials will be needed, as well their scope. Performing this effort early can help clarify the regulatory path and map the product development plan early thereby saving unnecessary and costly detour efforts that might increase costs and time. Working with a regulatory expert will be valuable along the way, but an early understanding of the regulatory path ahead is crucial.
The Product Development Plan is a “living document” and can be changed along the way if needed, but having the plan helps ensure that the testing is focused on the product development goals.
Streamline the Regulatory Path During Medical Device Prototype Testing
Too often companies perform studies which are not designed to help the regulatory path. Simply adding key endpoints can pay dividends for using a study in a future submission – even in medical device prototype testing. If these early studies are performed well, they may bring additional data to a submission to demonstrate efficacy or other aspects of a device therapeutic evaluation, even if they are performed non-GLP.
Focus on having a Pre-submission meeting as early as possible – once a device is in the final stages of development. Getting the preclinical plan (GLP safety study, biocompatibility testing plan, and bench testing plan) evaluated and getting feedback from the FDA in the Pre-submission plan greatly helps add clarity to the effort. Be sure to listen to the FDA when they tell you something. Having been to numerous FDA meetings, and hearing from multiple former FDA reviewers, we know the FDA wants to help Sponsors get through the regulatory process. While it sometimes may seem as though their feedback is obstructive, many times they are trying to relay the secrets to a successful submission. Too often we see Sponsors who want to ignore the advice of the Agency – only for it to come back and impact them later in the submission.
Alternatives to Costly Preclinical Animal Studies in Early Prototyping
Look for cost effective ways other than jumping into preclinical animal studies to get early data. Preclinical animal studies are expensive and too often there is a temptation to get animal data before a product is ready to be tested in vivo. Look for ways to do early bench testing on your device performance rather than jumping into preclinical animal studies. Wait until medical device prototypes are functioning and ready before spending the money. The closer a product is to a final finished device, the more likely early data can become useful in support of regulatory efforts. This can be an added bonus for testing the device at later stages.
Utilize cadaver specimens (human and animal) to answer questions of anatomic fit and other endpoints that are achievable as long as active physiologic systems are not necessary and can be avoided. In many cases anatomic endpoints can be informed largely through this strategy.
Other options include computer simulators and models for physiological and anatomic use which can help inform device design decisions. Utilizing these options may save money up front, and this effort is also consistent with animal welfare considerations. The “3R’s” include reduce, refine, and replace animals whenever possible for studies.
Optimizing Study Size and Animal Model Selection
When performing preclinical animal studies on medical device prototypes, use the optimum number of animals, the right species, and the ideal in-life time for the study. Try to utilize species that are appropriate for the study endpoints and device type. If you oversize a study it can lead to expenses that are not necessary, but more often we find there is a temptation to undersize a study to save money. This can lead to difficulties in data interpretation and having to repeat studies, thereby adding cost to overall product development effort.
Species choice can be informed from literature, prior submissions (FDA database), and discussions with testing labs. Using the right animal model early will save time and money down the road because of learnings with the model. While it may be tempting to go with the cheapest model, it may or may not be the best approach. Working early during prototype testing with the animal model and study design that will be utilized in the GLP safety and performance studies later adds significant value. Model related issues may be resolved and procedures refined so that the GLP study will run more smoothly. Study time may be acute, short-term, long-term, or even chronic. This depends on the endpoints of the study. It is often tempting to avoid longer duration studies in this phase but be sure to ask the question if there are critical failure modes that need to be understood.
Examples of product use where understanding longer in-life endpoints may be valuable for reducing later GLP study size and duration include such things as degradation curves, materials response, and device function over time. If these device characteristics can be defined early, it may save money in the long run for later cohorts in pivotal studies.
Keeping Preclinical Studies Simple and Focused
Sometimes trying to reduce costs can actually end up costing more! We often see Sponsors wanting to perform evaluations with either too few animals and endpoints or loading in too many endpoints per animal in order to save money. It can be tempting to overload study designs and put too many objectives in that might compete with a clear and clean data set – resulting in “a whole lot of nothing” when the data comes in. While it is noble to maximize the use of animals, be careful not to confound studies with too many competing endpoints that could add unnecessary details in the data evaluation. Extraneous details can cloud understanding of the data. It is just as damaging to do too little and assume a device is ready for final product testing. When designing a study, be sure to evaluate every aspect. Focus studies on endpoints that are needed and will likely be achievable. Don’t do expensive evaluations that the FDA or Notified Bodies don’t care about.
As medical device prototypes go through the iterative process of moving towards a final product, avoid performing overly large studies. Try to be efficient and save for the large regulatory studies you will need to perform once a device is finalized. It is easy to waste a great deal of time and money performing very large studies on early medical device prototypes. Keep the studies small and iterative with the device development along the way ensuring a device is performing as expected. Then, when the device demonstrates efficacy, larger studies can be planned. We sometimes see product developers perform studies on products with each iteration of the device. This effort is often rationalized as doing something to demonstrate the product is advancing, rather than an effort that is aimed at obtaining good data. Before you embark on a long, drawn-out effort of endless studies all on virtually the same device – optimize first and perform smaller iterative studies early before jumping to another study.
Having expert help when designing the studies helps ensure key data is captured regarding efficacy. This data can show investors and funding agencies the usefulness of a device. Stay focused and avoid an academic pursuit which could lead you off track of product development advancement. Second opinions can help refine and optimize the data that is collected in the study. Including multiple parties on this aspect ensures studies are cost effective without needing to be repeated because of missed opportunities.
Aligning Study Goals with Product Development Objectives
Be aware that publication goals, marketing goals, and investor information goals can differ from product development goals when designing studies in this early phase. If the goal is to publish a paper, then the endpoints of the study will likely be different than goals related to future regulatory efforts. Define up front what the data will be used for and how it is going to help product development. Both publication and regulatory focused studies advance products, but often for different reasons. It is OK to have both marketing and regulatory goals during the product development process. In some cases, these goals can be included in a study. However, be honest with the intended outcome.
In some cases product development entrepreneurs have published papers, only to be disappointed that the FDA does not accept their data for submission because of how a study was performed. Build your studies to get the most out of them. Some studies can be designed to accommodate multiple objectives, and sometimes the objectives compete and should be separated. Carefully consider how the study fits into the product development plan and review the impact of competing goals in the study design.
GLP vs Non-GLP Studies: Choosing the Right Moment
There is always a drive to get critical regulatory testing done to meet timelines, and it is tempting to try to push forward with devices that are not yet ready. For most medical devices, preclinical animal testing will include a suite of ISO 10993 biocompatibility tests, GLP safety, and often times performance testing. Do not jump into the GLP safety and biocompatibility testing too early. If device development is still underway and a device is not in its final finished form (or representative thereof) then it is best to perform iterative non-GLP developmental studies that inform the final finished device. The investment will be more likely to pay off with an uneventful GLP study by understanding potential risks of a product prior to launch of the study – which is an ideal outcome. The risk of the FDA or Notified Bodies rejecting data from products that do not represent the final finished device is too high.
The Value of Experienced Teams and Labs
Working with experienced professional labs who understand the therapy space of your device is extremely valuable. Even if costs may be higher than a more inexperienced lab, the investment is most often worth it. With medical device product development, time is the most expensive commodity. Experienced labs can bring lessons learned from their past experience and can help collect data that are crucial to the next steps in the product development process. Working with an experienced team typically results in studies being run more efficiently because there is less of a learning curve than from an inexperienced team. Ensuring the right data is collected will help avoid costly repeat studies. In some cases, with unique devices, there is no lab that has the experience needed. However, labs broadly experienced in the therapeutic space can still bring great value to the table by ensuring critical endpoints are included in study designs.
Avoiding Costly Milestone-Driven Mistakes
Avoid performing studies just to show progress in product development before a device is ready to be tested. Companies who are milestone driven by deadlines from investors often perform preclinical animal studies on prototype medical devices that are not complete – only to have to repeat the studies later. This can be a culture issue in some companies where there is a push to get preclinical animal studies started, and often have too rigorous of a timeline for entry to market. Rushing things often leads to mistakes and wasted effort. While we all understand the importance of keeping to a tight schedule – there needs to be a realistic and honest evaluation along the way ensuring the device is ready for next steps.
Meeting milestones without flexibility can be deceiving and very costly for companies – and investors. Timelines need to be honest, achievable, and transparent. Good product developers anticipate delays and issues along the way and build it into the plan, along with how to deal with them. Pausing and recalibrating is a common event in medical device development and should be anticipated and planned along the way. Delays can come from manufacturing, testing, raw materials shortage, economic factors, or other outside factors that slow things down. Seasoned developers are aware of this and manage expectations to investors. Don’t over promise and under deliver. That generally leads to disappointment and frustration for all parties.
Knowing When to Pivot: Letting Go of Bad Ideas
A bad idea will never make it in the real world – and hence is costly, wasteful, and potentially dangerous to patients. While it is important to keep an open mind for innovation, there are certain early indicators that a product will be a failure. It is better to end a product early than keep chasing a dream that will never be a reality. It is difficult to step away and see this from an outside perspective. Advisory committees and non-biased candid feedback can be helpful here. Developers need to give up “great ideas” and realize when it is time to move on from a product.
Material Choices: Balancing Innovation and Regulatory Ease
If possible, use common component materials in building prototypes for medical devices. Use of novel materials and new therapeutic methods raises more questions in the regulatory process – and hence will increase the burden of data needed for the regulatory submission. If there are novel components needed, it may be wise to ensure some early proof of safety related to their use in the protocol to avoid having to change materials or suppliers after the final finished product is built and undergoing biocompatibility testing. Do not cheat the quality of the product. Poorly built products are destined to fail. Patients getting implanted or having a device used on them want the best product possible. Early-stage companies that try to cut corners by using manufacturers and components that are cheap are often unsuccessful. Be efficient but not “cheap” – understand the cost of doing business. This often leads to the device failing in preclinical animal studies, requiring the studies to be repeated and increasing both cost and time. The medical product development effort is expensive – repeating testing because the device is flimsy will only add to the costs. A quality build up-front will save a company both time and money.
Summary
Successful companies stay focused on their product development path. Start with a solid plan for implementing and testing the product. Do not get distracted by extraneous details. A solid strategy will ultimately save money and time during the preclinical prototype testing phase and will help move the product development process forward before the your budget runs out.
Frequently Asked Questions (FAQs)
Should I perform GLP studies for early prototypes?
No. GLP studies are best reserved for stable designs and regulatory submissions. Use non-GLP feasibility studies first to refine device performance, surgical technique, and endpoints. Once your prototype demonstrates repeatable safety and efficacy, transition to GLP for formal safety evaluations. This staged approach saves time and budget while reducing risk of costly rework.
How do I choose the right animal model?
Match the model to your device’s anatomy, physiology, and healing timeline. Consider:
- Published literature and models used previously with the device type.
- Previous FDA submissions from competitors
- Device size and ability to implant or use in a given model
- Ethical considerations and 3Rs compliance
Ask your CRO for a model recommendations before committing
How do I choose the right CRO for preclinical studies?
Look for a CRO with integrated capabilities: experience with the medical device type, surgical expertise, the right supportive resources such as imaging (e.g., OCT/IVUS), pathology, and biostatistics under one roof. Ensure they offer appropriate models, GLP compliance, and flexible study staging (bench, ex vivo, in vivo). Ask about their regulatory experience with your device category and ability to design lean protocols with stop/go gates that meet regulatory requirments. Transparent timelines, standardized data capture, and rescue study experience are critical. A strong CRO partner reduces cost, accelerates timelines, and delivers decision-quality data for regulatory success.
