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If you are a Medtech entrepreneur, you’ve probably heard too many times investors asking, “How far are you from market?” “When can we sell it?” “How long will it take?” Sometimes we just want to answer, “Well, if you give me ALL the money I need right now, it will be way faster.” But no, we don’t say that, this is the part where we discuss our action plan and timeline for the development of our medical device, the milestones and the money for each stage, the better the plan, the safer the investor feels.
And this is where a TRL scale comes in handy. TRL stands for Technology Readiness Level, developed by NASA during the space shuttle programs. In simple terms, this scale tells you where the technology is in the development process starting on the concept all the way to “Ready to Launch”. It helped NASA take important decisions and since then it has been adopted by many industries, including the Medical Device Industry.
But why should I care about this scale for MY medical product?
Well, just as we measure the level of “hotness” with a thermometer, the TRL scale measure the level of “hotness” of a technology. The higher the measurement the hotter it is to market and therefore to the investor. And you are looking for money, right?
Ok got it. But my medical product is not a rocket, is not THAT complex. Why should I use this scale?
Here are the top 5 reasons:
1) It is applicable to all technologies, no just space shuttles.
2) It helps you understand where your project is, so you can know where you need to go, this clarity is needed in every entrepreneur’s life, trust me.
3) Helps you take better decisions.
4) You better communicate with investors; they understand your progress.
5) Almost all government funds have adopted this scale to measure your status, if you want money from them you need to understand it.
First, you need to really understand the levels in Medtech, here is a simple explanation for each one:
In here you are still reading scientific papers and research literature. Normally we don’t have yet an application defined in this stage.
You know change into your lab coat and go test some hypothesis that will give you more insights about a potential application for your idea and/or technology.
Your experiment is a success, you now have scientific evidence that your idea works. Normally the proof is at lab level and not considering all of the variables for your application, it focuses on proving the primary function of the technology.
You need now to build a prototype that integrates more of these variables. We call this part the first ugly prototype because it is far from a fancy looking medical product, you use materials that are not the optimal or final, and normally we use available components or resources to build it. Main objective is to verify the primary function through lab or benchtop testing.
In here, you are iterating your prototype and testing it in simulated conditions. This means that you are now testing different materials, shapes, components, and through the use of engineering you simulate the user, the environment, the important variables applicable to your medical device. You can use simulation software or testing under simulated conditions. After level 5, Product Development phase starts.
If you reach this point, you are transitioning from Prototype to Product. This includes DFMA activities for your medical product and testing on a relevant environment. A relevant environment may be for example animal model testing, early testing with users, etc.
In here, product material components and fabrication processes are well defined. We convert the Design History File (DHF) into the initial Device Master Record (DMR), in order to transfer the design to manufacturing. We have small batches of your medical product produced (pilot runs) with the final materials, components and manufacturing/assembly processes inside an adequate production facility (ISO Clean Rooms) and then send the units for Validation Testing, such as Biocompatibility, Sterilization, Clinical Trials, etc. Both product and process are integrated at small scale.
You can achieve final integration when your medical device is fully tested and evaluated for safety and efficacy. This normally means via clinical trials or testing in a real environment with the final medical device. All verification and validation testing has been completed and the evidence submitted to FDA for evaluation.
The finish line. You have received FDA market clearance or approval; you have a finished product with a stable manufacturing process ready for large scale production. Congratulations, you are now ready for Market Launch.
Now, that we understand why TRL scale is important to us and how to use it, I should let you know that it actually doesn’t work. Just kidding, it does work but after years of experience in developing new medical devices and working with other startups and entrepreneurs in the US we learned to include other factors to really get the “hotness” level.
You know, sometimes biomedical startups came to us with a complete working prototype, and wanted us to help them advance their development, technologically speaking they had great advancement in the scale, but had no market analysis, business model, or even regulatory documentation at all. So in the TRL scale they were very near market, and at the same time not really.
So, we took our experience and came with a new tool to help medical device startups and entrepreneurs understand their level. We call this the Overall Medical Device Readiness Level, MDRL for short. This new scale measures the technology, regulatory and commercialization levels applicable to medical devices to really understand where you are at overall.
And the best of all, we made a free calculator for you, just answer some simple questions and it automatically gives you your MDRL level.
Hope this tool can help you understand better your status in the medical device development process and use it to go out there and get your investors!
“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
Mark Lee
CEO, Ocumetics
"Our experience with Bioana had been outstanding. Their commitment, eye for detail, punctuality, proactivity and understanding manufacturing principles, workflow, quality and resourcefulness has been beyond our expectations."
Frank Harder
CRO , Bolb Inc.
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