The advances that have occurred in digital, biomedical and data technologies bode well for the medical device development process. It must be said, however, that even if a new idea works from a scientific or clinical point of view, it doesn’t necessarily mean that medical device development and market adoption will take place.
The transition of a device from concept to physical product is not linear and straightforward, but complex and dynamic. It is also influenced by various factors that can be of various nature, e.g. technological, environmental or related to user interaction and perception.
Unexpected problems can derail the process when Med-tech manufacturers do not start the medical device development cycle with an overall view from the beginning. Problems that may seem small at first glance can then escalate, resulting in product disapproval, delayed release, poor uptake or even life-threatening and regulatory recalls.
Here are ten of the most common mistakes.
1. Not understanding the market
Knowing the market in which you will sell your device and how it will be used is information you need to know at all costs before you decide to start designing it. If the market is not big enough, there’s no real financial route to market. Often, engaging in medical device engineering without fully understanding the market, occurs when much more emphasis is placed on technology rather than knowing the market and consequently creating something that the market is looking for. Often Med-Tech companies start a project and develop something that turns out not to be what the market is looking for.
2. Skipping the validation steps
Skipping the medical device prototype validation stages and going straight into production with an early prototype is usually a big and expensive mistake, or, at the least, a very painful exercise. If time is really important, it may be worth sacrificing the costs later on.
3. Poor documentation
Re-documentation costs time and money. A good regulatory submission can be lost due to poor documentation. This will delay bringing the device to market.
4. Regulation planning
Many products encounter problems in the final stage of the Medical device development process. Navigating through FDA and EMA failures is a risky and expensive game – a lot of resources have been invested and the stakes are high. The most common medical device failures include:
- lack of procedures to take corrective and preventive measures
- analysis of device failures
- non-conforming equipment
- non-compliance with documentation
5. Ignoring risks
Potential risks are often ignored with the hope and assumption that everything will be fine in the end. Instead, this leads to having to do a lot of work all over again once the problem becomes apparent and needs to be dealt with properly. It is quicker and cheaper to do this from the beginning by doing a proper risk analysis.
6. Picturing the final product too early
Several targeted experiments need to be carried out to address the big risks. Medical Device prototyping takes time and waiting too long before looking for meaningful test results, burning money on things that are actually super-risky or unimportant, means moving on without it leading anywhere.
7. Failure To Plan
You need to identify critical interfaces in your project, the resources you need, the goals you need to achieve and make the medical device design reviews. This will help you get your device to market as soon as possible. It is important to be aware of the right path to take with your product development so that you can plan accordingly.
8. Ignoring ROI
One of the main mistakes to avoid in medical device development is to ignore the Return of Investment (ROI). Even if your project is amazing, your efforts will be in vain if nobody has the money to pay for it.
9. Ignoring Non-Medical Device Regulations
It is not right to ignore non-medical device regulations such as chemical regulations, as doing so might prevent you from marketing specific products. Even if they aren’t regulations that directly affect your medical device, very often they apply to it anyway. It is good practice, therefore, to be aware of the regulatory landscape of your product at the beginning of the medical device development process, in order to take this into account during the development and avoid unpleasant and costly surprises at the next stage.
10. Designing A Piece of Technology Instead Of A Product
Remember that even the best technology in the world will go to waste without the right market. Before designing, you need to think about the impact of your medical device on the workflow of the technicians, doctors and patients who will use it. Think about how it will fit into medical practices and the revenue stream that comes with it. If your device could bring a loss of income for medical procedures, with no revenue to compensate for that loss, then it won’t be adopted by medical practices.
Product development is not a linear journey, but rather a complex end-to-end process.
The journey from concept to regulatory approval and widespread use of the final product is fraught with challenges which can be managed or avoided if there is strategic interdisciplinary collaboration early in the process. It’s important to consider how a device will be used, distributed, paid for, evaluated, monitored and updated, identifying where problems might arise.
This can be done with input from specialists at the beginning of the project, during the Medical Device prototyping. Combining the expertise of professionals such as manufacturing engineers with mechanical and electronic engineers; problems can be anticipated and addressed before they have a serious impact. Relying on assumptions rather than solid and proven insights can lead to major problems that undoubtedly harm progress.
Proof that a device works is no guarantee of success. But taking targeted steps to bridge the gap between idea and use helps to reduce the risk of problems, increase the likelihood of commercial success and ultimately deliver benefits to all stakeholders.
If you need expert advice for your next medical device, Creanova guides healthcare companies through the entire medical device development process, from the earlier stages of requirements definition and feasibility study to the medical device design, engineering and prototyping, up to contract manufacturing (ISO 13485 certified).
So, contact us and we’ll build with you the right plan for your project so that together we can bring your idea to market in the most efficient way.