Oct 14, 2013

Blogs worth reading - creo Quality

creo Quality has a couple of excellent blog posts worth checking out, first off is Fast and Furious Medical Device Product Development: 
Ten months ago, I started a medical device product development project with an entrepreneur / CEO. The goal he made very clear was that before the end of 2013, he wanted to have the device on the market. The device is semi-complicated. It’s an electronic gadget driven by custom firmware. Plus, there are plastic parts and pieces, disposable components, and so on. Before kicking off the project, I had a few conversations with the CEO about project timeline. He reiterated time and again one year, one year, one year. I told him that while theoretically this schedule was possible, 18 months was more realistic–mostly because of FDA wildcard. So we talked about FDA and 510(k) process. After hearing about all of this, the CEO said he thought FDA would only take 90 days to provide clearance and that we should plan accordingly.
 Read the blog to see where they are now.

In early July, I submitted a 510(k) for a fairly simple and straight forward disposable, single use device. The predicate was a very good match. Of course I followed FDA guidance documents, checklists, etc. for what to put into a 510(k). I also reviewed the RTA checklist as I compiled the 510(k) documents. Of course I felt the submission was complete. Why would I send it to FDA if otherwise? A couple weeks after submitting, I received a “refuse” response from FDA. The response included the RTA checklist with reviewer comments.
 I have never been part of a refuse to accept from the FDA, but this: 
In early August, the RTA response was submitted. A couple weeks later, I received a phone call from a FDA reviewer–someone different than the person who first reviewed the submission. He had a few questions, I had a few of my own. He said he would get back with me and did so the next day, this time with a few more questions. I was kind of confused at this point. Some of the things he asked about was marked as fine by the first reviewer. Other points of discussion pertained to how we addressed the issues identified by the first reviewer. Keep in mind, we discussed the specific action plan with the first reviewer who agreed with our plan. Any way, the second reviewer said he needed to discuss the issues with the branch chief and would get back with me.
 I have had happen, one reviewer at the FDA says do something this way, the next reviewer goes the opposite way.  In my case I was only involved in the second reviewer part, but we had conducted some biocompatibility testing based on the first reviewer's comments, the second reviewer didn't like the methodology.  We were able to back the testing up with other data, but it was not a sure thing we wouldn't have to repeat the testing entirely.  It was very frustrating for the entire team and the management.  However, there is not much you can do but suck it up. 

A similar situation happens from time to time in a company, say a new regulatory person on a project will have a new viewpoint, however, the good ones will generally only voice the opinion then not push it unless they absolutely think it is a show stopper.  They will stick with the old decision instead of refocusing the entire team to their whim.  Quite a few people are unable to distinguish between "Must Have", "Nice to Have", and personal preference.   Probably 90% of the comments I see are personal preferences that reviewers have.  Those are fine to have early in the process when many edits are being made, but a waste of time later on.  Think about it next time you are considering rejecting an ECO.


Anonymous said...

nice blog :)


May Johnson said...

Here i got lot of creo device information. I will revisit here so many times.
How Parazapper can Help for Diarrhea
In Bangladesh, every year many poor children are affected by Diarrhea. A NGO publish their collected survey data. Every year rural children are affected by diarrhea 4.5 times and 230000 children die, where 8287 children are under five years.
Recently some years this condition has changed cause most poor people are aware of the disease and their economic condition has developed.
Govt. and some NGO are working on this field. For improve awareness about Diarrhea already added diarrhea topic with text book and NGO giving training voluntarily.

Diarrhea infection has some cause. Different types ages people affected by the disease different virus. Children are mostly affected by the rotavirus, which age is under 5 years. Adult are affected by the astroviruses. Virus and bacteria both are responsible for the disease.

Rotavirus vaccine can decrease the rates of diarrhea in people. Proper hand washing and fresh food is effective for prevention of diarrhea.
David Etheredge has innovated a LVPEF device that kills many microbes in water, which is called ParaZapper. It can eliminate virus and bacteria from water within 2 hours.
I was found effective news on that site. There has lot of information about ParaZapper device.
For additional information see: http://paradevices.com
ParaZapper products are sold at http://huldaclarkparazapper.com

Tradegateway said...
This comment has been removed by the author.
shamsher khan said...

Very nice post, impressive. its quite different from other posts. Thanks for sharing.
flipkart coupon

plastic injection molding said...

Helpful guide for me.Thanks a lot.

Apu Mridha said...

Thank you for sharing such an amazing and informative post. Really enjoyed reading it. :)


Medical Cost Containment