How to Work with MedTech Engineers: A Guide for Clinicians
Clinicians and MedTech engineers often encounter challenges that existing devices and medical literature cannot solve, creating opportunities for innovation. This may involve repurposing existing technologies or developing entirely new medical devices. While the journey from idea to product can be demanding, collaboration between clinicians and engineers makes it possible to turn clinical insights into solutions that improve medical practice. This article outlines the innovation process and shows how clinicians can transform their ideas into real-world medical devices through effective collaboration.
How MedTech Engineers Help Navigate Medical Constraints
A medical device development journey is full of challenges and limitations that are important to recognize from day one. The first is that you simply can’t do it alone. Even the best idea needs a strong team behind it: engineers to handle mechanics, electronics, software, and firmware, regulatory experts to navigate compliance, and of course, sponsors or funders to make such an expensive process possible. Then come the legal hurdles. In MedTech, not every clever idea can be implemented. Take something as simple as charging via a USB-C port, while it may sound convenient for the user, safety concerns and regulations often rule it out, since there’s always the risk of connecting an uncertified power supply. And finally, there’s design. A medical device has to be human-centered to truly serve patients and clinicians, but at the same time, it should remain as simple as possible to speed up manufacturing, cut costs, and make scaling realistic.
Defining a medical product
Work on an innovative medical device always begins with identifying an unmet clinical need. This is the spark that mobilizes action. At this stage, it is important to look at the bigger picture: How significant is the problem? What are its key characteristics? The process of creating a solution is rarely a solo effort. Typically, it’s a close collaboration between clinicians and MedTech engineers.
Doctors define the problem, while engineers ask the right questions to uncover opportunities, patient needs, and the root cause. Together, they aim to define the requirements for a potential device including function, safety, maintenance and market fit. The search for solutions usually starts broadly. Different concepts are generated and discussed to determine which approach best addresses the defined problem. Market analysis is also conducted to check whether similar devices already exist.
At this stage, clinicians and engineers ask themselves:
- What are the unmet needs?
- How can we meet them?
- How well does a potential solution address those needs?
How MedTech Engineers Help Navigate Medical Constraints
From Concept to Prototype – Working With MedTech Engineers
Once the problem is clearly defined, the next stage is design and prototyping. The process usually starts with a proof of concept, a simple model that demonstrates the idea is technically feasible and has the potential to deliver the expected results. From there, teams move on to preliminary prototypes. These early versions are not meant to function yet, their role is simply to test dimensions, shapes, and ergonomics. They are produced quickly and inexpensively, often with basic technologies, to save time and resources while still making the concept tangible. The next stage is building functional prototypes. These models are designed to actually work, allowing the team to assess whether the device performs as intended. Development at this stage is iterative: each version is tested, refined, and improved until the results meet clinical expectations.
This step-by-step approach offers two major benefits. First, it enables MedTech engineers to detect and correct errors early, before they become expensive to fix. Second, it allows clinicians to share prototypes with potential users and collect valuable feedback, which guides further improvements and ensures the final device truly meets patient and provider needs. Once the design works in the lab, it’s time to test how it performs with real patients.
Clinical Trials Stage
The clinical stage is where the idea finally meets real patients. For higher-risk devices, clinical studies are often required before approval, especially when the technology is new or when existing data isn’t enough to prove safety and effectiveness. These studies take place in real clinical environments, with patients who represent the intended user group. Clinicians’ role here is pivotal.
They help identify which patients can take part, ensure the study runs safely, and provide expert insights into how the device performs in practice. Meaningful feedback is what determines whether the device truly delivers value at the bedside. MedTech engineers, on the other hand, make sure everything is documented correctly and that prototypes are updated based on clinicians’ observations. Each round of patient feedback leads to refinements, sometimes small tweaks, sometimes major changes, bringing the device closer to a safe, effective, and user-friendly final product.
From Concept to Prototype – Working With MedTech Engineers
Legal Requirements in Medical Device Development
From the very beginning of development, it’s important to remember that no medical device can reach patients without meeting legal and regulatory requirements. In the European Union, this means complying with the Medical Device Regulation (MDR) and completing the certification process to obtain a CE mark, without it, distribution is not possible. While MedTech engineers lead on technical standards and documentation, the ultimate goal remains patient safety. To support compliance, harmonized standards help align devices with current regulations. Maintaining proper documentation from the start of the project is therefore essential. With compliance in mind, the next step is to make ideas tangible through prototypes.
Final Thoughts
Close cooperation between clinicians and engineers is key to creating meaningful medical devices. Two seemingly different worlds: medicine and technology are coming together in the medtech industry to transform the future of healthcare, diagnostics, and home-based care. The field is moving in many directions, from miniaturization to the development of wearable sensors that give doctors continuous insight into patient health, not just during a single examination. That is why it is so important for doctors to be involved in creating new solutions: they know best what truly matters for their patients.
At Consonance, we believe in the power of clinician – engineer collaboration. We did that multiple times already. Together, we can make a difference.
Sources:
https://pubmed.ncbi.nlm.nih.gov/34394638/
