#Lesson : Do not loose sight of the big picture !
I wrote this more than a year ago on another platform and want to keep it here as well.
1- Look at the big picture , FROM ANOTHER PERSPECTIVE ..
I slightly moved from one areas to another ( Not major changes, from Biology to Cognitive Neuroscience then to Motor neurorehabiliation research fields) .. and for the last three years I was doing pure research… by that I mean that most of my readings lately are articles about some very specific sub-sub-sub field topics.
In this course, we needed to have a project ( I chose to make a medical device since I did not knew a lot about it tbh), and prepare weekly presentations.
This has led me to read about different regulations ranging from device manufacturing, patents, softwares to clinical trials! And I DID learned a lot!!! I have realised that I might have lost the big picture on the way ..for example how the “feasibility” of what you propose is a major key to not loose sight of) .. ( I KNOW its obvious, right?..)
I have also learned that there is a specific International Medical Device Regulators Forum (IMDRF) , which I found through searching in the FDA website that define and regulate softwares intended for medical puroposes and thats its under the section of : “Software as a Medical Device (SaMD)”
So this was really cool!**
What I am trying to say is herethat , I have not only dived deeper into different aspects of a biomedical project making process but I had also had to look at it from different perspectives, I was not trapped in the research scientist POV, but also CMO, CRO as well , and this was really nice fresh up to do!
2- I enjoyed reading regulations and searching for patents
Something DEF that you need to know if you are about to launch something (OFC it can be out-sourced, But I always want to know a bit about whats going on, so this is a major plus as well)
I also realised that its would not be something I would enjoy doing for a long time in the future( My brain needs to constantly learn/and have new tasks). Well, okey lets not be veryyy Carré about it , I might do it for a while to know a bit more, who knows .. )
3- If you are doing research on a specific topic for a long time , take the time to read once in a while the major guidlines from international medical associations or organisations .
I know this also seems too obvious .. but in my case , I realised that I have not done it very often lately… (So this is a lesson to myself). Its good because (1) you stay updated for new assessmenet tools and (2) Medical doctors guidlines can really help you deliver something usefull/needed (Here safety is an an evident step.. hein)
Nevertheless; the conclusion here is that : Yep, there are a lot of great ideas out there.. but how feasible are they IRL?..
This bring us back again to point 1 , Do not loose the big picture.
4- If I were to teach someday, I learned that the way the teacher delivered this course is a good one! I’ll definitly get inspired by it.
Again, I did had a lot of courses in my life, But I really enjoyed this way of teaching :
You are giving headlines and directions about the business model and major steps needed to build a biomedical project to deliver, and you go do the research/readings for your specific product! learning by doing is an excellent approach (for me).
5- My mindmap , or the Majors takeaways from the course content:
- Define a specific targetd function/disease/disorder ( Refer to ICD here ) in which your product/diagnosis tool/wellness tool is useful .
- Explain what is currently done to help solving the problem you want to solve, and why your solution is better in any way ( by explain I mean : take into consideration : 1/First : Patients(It is safe ?does it offers a better life quality for them then the existent product?) , 2/Doctors ( safety/efficiency/feasiblity again ), 3/Regulators.
- MOA and POC ( Machanism of Action/ Proof of Concept ) : Clearly define the what/how/why/what for.
- Look into Regulatory guidlines : Look through their websites , In my case I mostly looked into FDA regulations and Medical associations guidlines) And guess what, my device idea benefits from 510k ( i.e I will have less work if Iwant to release it), look into this very closely, you can save up time and money with proper research.
- Check existent Patents ))) Oh my and I always thought I did not express myself correctly in english:) Thats some hell of writing style) But it was a nice ride, my friend!
- Think in advance about the delivery of the product and feedback protocols : Think about of an efficient way to get all necesarry feedback from your hardware/software, and how you will get it so you can improve your device/product in the future.
- Most suitable assessmenet tools to test your device: Feasability, Safety, and Efficiency ( read..)
- Clinical trials : Here again , refers to international medical organisations guidlines, as well as the studies results published in scientific journals .. there is probably someone who did a similar thing and you can get inspired, or even better : It can point out something you missed.