If anyone has ever been starry-eyed, it's me. "I am going to get my PhD in only three years!" "I will have all this extra money with this new job!" "I will probably retire at 55!" Of course, at that point reality rudely awakens me. Shucks.
I am not old yet, but I am old enough to try and catch myself now when I start convincing myself about things like this. I smile it away and shake my head. Back to reality.
So it goes for other people, too. In my job, the one I hear most often is, "I will get my medical device with a hydrophilic coating through clinical trials and to market in six months!"
Well, if today is the first day you have talked to me about a hydrophilic coating on your medical device, no you won't. Sorry! Maybe six months from now, if all goes well, you can say that, but certainly not in our first conversation.
I have written similar articles on this blog before, and I still need to get the word out: Hydrophilic coatings are not trivial. They are sophisticated and advanced additions that add real value to some medical devices, and they require an entire level of attention to detail, all their own.
If you are coming to me with a six-month deadline to market, you are TOO LATE. My next line to you will be, "Can you extend your timeline?" By the way, this does not only occur with inexperienced startups developing their first medical devices. This sometimes happens with veteran engineers too.
So, why then?
It breaks down into a few reasons:
- Coating equipment always needs customization
- The coatings themselves often need customization
- Ordering machinery has a lead time
- IQ, OQ, PQ take time
- Devices with coatings must go through Verification and Validation, as per Design Controls, at least in the US
- Clinical trials, at least in the US, require an IDE if they are significant risk, which takes time to get
- FDA Clearance or Approval always takes at least 60 days
So, just do the math. A proper aging study on a hydrophilic coating takes 4 months if you want a three-year shelf life. You can do other things in parallel with that, certainly. The lead time on the equipment alone can be four to six months, so even if you get the equipment in just three months, you still need to do IQ, OQ, PQ on it. Also, this is if the type of equipment is exactly known from day one. That never happens because every catheter shaft has holes at different spots, or different diameters, or shapes, etc, or maybe it is not even a catheter so it needs a different kind of machine invented entirely. However, will that be possible if you still do not have your coating formulation nailed down yet? If you are assuming that you will get a perfect coating on your first sample run and simply scale things up from there, you are mistaken most times.
These things take time. Believe me, I would also love it if you could get to market in six months. It makes the money come in a lot faster. Reality is different. Usually all of these things take the better part of a year, if everything goes smoothly, and in many cases they take the better part of two or three years.
I do not want to discourage anyone from trying a coating. It can add real value to your device, and some devices may not be able to exist without one. I do want to educate people about how long this stuff can take, however.