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April 20, 2012 – FDA 510(k) Panel (INpact)

March 26, 2012 By Leave a Comment
Join us at our April meeting for a panel discussion on FDA 510(k). Representatives from
Pearl Pathways and Anson Group are expected to participate on the panel.
DATE: April 20, 2012
TIME: 11:30 a.m. – 1:00 p.m.
LOCATION: Bingham Greenebaum Doll LLP
                 10 W. Market St.
                 Suite 2700
                 Downtown Indianapolis MAP
COST: Non-members $20
Filed Under: All, Events, Indiana Life Sciences, inpact, Medical Device - General Tagged With: , , , , ,

510(k) Clearances Are Harder To Get Now

May 20, 2010 By Leave a Comment

A couple of Indianapolis-based medical device firms recently received FDA 510(k) clearances for their new products. One clearance took 250+ days. The other took around 100 days. One had a clearly defined predicate device. The other leveraged several predicates but did not have a single, clear device for comparison. I realize this is a data set of 2, but the message I interpret is this: Without a clear predicate, except lengthy 510(k) reviews with lots of questions–and hope you are able to receive clearance.

A blog post from Anson Group goes more into this topic. Here is an excerpt:

Also, currently, several predicates can be used to create a substantial equivalence argument for one device. This practice is now under scrutiny as the Agency believes that it may limit the number of predicates to a single device, which must be within the same device panel as the device seeking clearance.

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Filed Under: All, Indiana Life Sciences, Medical Device - General, Strategy vs. Tactics Tagged With: , , , , ,

Marshall Goldsmith – Thank You!

September 2, 2009 By Leave a Comment

Rose-Hulman’s Office of Outreach held an event on September 1, 2009 in Indy. The event featured one of RHIT’s most famous alums: Marshall Goldsmith. Very motivating, yet simple advice! Thank you!

I jotted a couple of thoughts during the speech:

  • Help more; judge less
  • Values aren’t what we say but what we do

Another coaching tip Marshall offered: Imagine that you are 95 years old and about to take your last breath. If you had a chance to go back in time to this very moment and offer one piece of advice to yourself, what would it be?

After leaving the event, I had a couple hour road trip. Plenty of time to reflect. One thing I thought about was thanking all those people and companies who have provided opportunities to me. Here is a short list:

  • Rose-Hulman – Is there a better engineering school?
  • Cook Medical – I had so many opportunities and responsibilty as an engineer fresh out of school. My experience at Cook established my professional foundation.
  • Theron, Inc. – I learned the good and bad of running a business. I’m forever grateful.
  • SonarMed – A medical device start-up willing to give me my first gig as Creo Quality.
  • Anson Group – Always there when I need them. I hope I help build their brand and integrity just a little bit.
  • FlowCo – Another med device start-up willing to trust my experience.
  • Suros (now Hologic) – Former colleagues from Cook willing to have Creo Quality help them multiple times.
  • Priio – Allowed Creo Quality to help refine their business using strategy.
  • Medical Polymers – Had faith in Creo Quality’s ability to help them improve efficiency.
  • Tomato Fish Marketing – Willing to bend over backwards to help Creo Quality grow. Great marketing partner!
  • INpact – I’m humbled by what this group has become. The credit belongs to the members.
  • My wife – There is no bigger chearleader for me and Creo Quality!
  • My kids – Have accepted that sometimes daddy works on the weekend. I plan to limit this and give them my full attention from now on. We all need this.
  • Boundless Design – Helps ensure the Creo Quality brand is as strong as possible. Plus, she is my sister and endured a great deal from me growing up. Sorry!
  • My parents – Thank you for establishing ethics, morals, and principles. I hope I can do half as good with my kids.
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