Seminar Notes: Medical Device Product Development for Startups, The Bitter Pill

medical-device-development-bitter-pill-padt-0About 40 people joined us at CEI this Monday at the start of Arizona BioScience week for some blunt talk about Medical Device development for startups.  It was a great crowd and the quesitons were almost as (OK, maybe more) useful as the talk.

The gist of the seminar was a look at what it really takes to develop a medical device.  We talked about the FDA, ISO 13485, QMS’s and the very well defined process that all companies must follow.  We also talked a bit about tansfering to manufacturing and shared some lessons learned.

You can find a PDF of the presentation here: padt-azbioweek-medical-dev-bitter-pill-1.pdf

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We look forward to seeing more of you at other AZBio Week events including the AZBio Awards on the 21st and the White Hat Investor conference on the 22nd.

As always, PADT is here to help with your medical device product development, or with the development of any product.

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Ulthera Purchased by Merz

Ulthera-Hand-Piece-SmallWe love to see our customers succeed – everyone here that has worked with Ulthera knew it would only be a matter of time before a large player recognized the value of this company. And, we just learned today that the German pharmaceutical company Merz is buying Ulthera for $600,000,000.  

Here is a link to an article on the sale, and here is a link to the press release

PADT worked with Ulthera to help them redesign their hand-piece design.  The process, called Ultherapy, is a non-surgical, non-invasive procedure for the face that uses high density, focused, ultrasound and the body’s own natural healing process to lift, tone, and tighten loose skin. Some of our employees also volunteered to test the device and pose for marketing material.  

Read about the work we did in a case study we published a while back.

Congratulations to everyone at Ulthera and we can’t wait to work with them again to help improve and grow this device and others in the future.

NeruoEM’s Featured in Phoenix Business Journal

It’s always nice when a customer gets a mention in the local press. PADT is helping NeruoEM in the development of a “a self-contained head device to prevent and treat Alzheimer’s Disease (AD) with electromagnetic waves.”  Check out the write-up here.  

There is not a lot we can say about the project or what we are doing for NeuroEM, but the website and article both give a good overview.

Needless to say, the older we all get, the more desire we have for this device to transition to an approved medical device.