2 min reading time

It wasn’t until I transcribed Dr. Howard Levin’s presentation from our last 10x for ENGINEERS event did I realize how much his past 15 years he packed into 25 minutes.

It was fantastic presentation for anyone who ever works in bringing a medical device concept to market.

The video, slides, and transcript are immediately available for you now at https://medgroup.biz/Howard-Levin.

For credentials, Howard’s company Coridea issued 120 US patents, raised $100 million, and returned more than 1.4 billion to investors.

Have I got your attention? Some key takeaways but srsly, download it:

• A university gets a patent on a concept constructed with “academic engineering” (different than “real engineering”). When they find the idea, as written, is unworkable, they’ve effectively shut everyone else out from expediting the innovation to market.

• A device may be good for mankind but not for business. You, as a medical device design engineer, get pitched more ideas than you can execute. How do you choose?

• If you consider taking equity as a form of payment, how do you minimize the risk there’s no payout at all?

• “Breakthrough therapies tend to start in academics; better tools developed by industry or clinicians.”

• Determine if the physician wants help developing clinical data and generating

IP for acquisition versus help manufacturing the device you’ll make money on selling.

Then Howard took us through a dozen questions to ask, ranging from clinical need to regulatory risk to sales and marketing.

As I said, a really worthwhile presentation. Replay, slides, and transcript at

https://medgroup.biz/Howard-Levin

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How familiar are you with risk analysis according to ISO 14971?

If you have a few moments, would you take this short Jama Software survey? They basically wanna know how medical device manufacturers perform risk analysis.

It’s, like, six questions, the first of which is your level of familiarity: None | Somewhat | Mostly | Expert. So if you have the time, I’d appreciate it.

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Discussions You May Have Missed

In this section, I highlight some of the recent contributions from group members because, hey, this is a community we have here! Please, add your questions right here.

Kyle Vlasak, VP Sales and Marketing at Vonco Products, asks, “Why is PVC the go-to when developing liquid tight medical fluid bags in the US?”

Saurabh Dubey, Junior Regulatory Affairs Manager at Syngene, asks for “Help with 510(k), GTIN, and GUDID.”

Christian Costantini, Regional Sales Manager Americas for Redax Spa/Maclin Power, asks, “Who provides market intelligence services for the medical device industry?”

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Our Next Event: October 10-12 in San Diego

The event is geared equally for senior and junior levels. If you’re senior, you’ll return with ideas the team can use. If junior, you’ll return with specifics lessons, materials, and action items to do your job better.

 

Want to see what 10x for ENGINEERS is like? Watch this short recap video.