4 min reading time

If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize.

His was a really solid talk. I’ll share the first of his five questions here. You can find the rest on the 10x Medical Device Conference blog. It includes his slides and talk transcript.

Or watch the video below.

Is the contract manufacturer even asking for the right things?

Far and away, if your prospective medical device contract manufacturer doesn’t ask you the right questions up front, you know you’re in trouble.

So what should he ask for?

• Your Device Master Record (DMR). They need to know: Your bill of materials, your suppliers, your manufacturing work instructions. If you’re manufacturing for the first time, they have to work these out with you.

• Your process validations. Otherwise, how will they know if they’re doing it right?

• Your design requirements. Might they change some elements to scale manufacturability for higher yields? They can’t make those suggestions without your requirements.

• Your availability to see his manufacturing facility. Mark’s had cases where the contractor wouldn’t let him on the floor. That’s a quick way to lose an engagement. What are they hiding? Are you going to be partners or not?

Action Item: If you manufacture medical devices, do yourself a favor and download all of Mark’s questions.

May 15-16 in San Diego: The 10x Medical Device Conference

10x is a cross-functional event. We invite experts from the entire medical device ecosystem to give you a one-stop shop to answer all your questions about how to:

• Design and develop your medical device;
• Submit applications to regulatory bodies domestically and abroad;
• Improve operational excellence across your entire enterprise;
• Gain market access through reimbursement, with an understanding of health economics and value analysis committees;
• Market and sell your devices to hospitals, primary care, direct-to-consumer, government, and more.

Here’s the whole point of the Medical Devices Group and why you should attend 10x:

The Medical Devices Group can answer all your medical device-related questions.

We have a huge network and believe in the power of community and superlative attention to your needs.

We’re building this site, MedicalDevicesGroup.net, to be the world’s most useful website serving the medical device industry.

Similarly, 10x events are designed to be the world’s most useful medical device conferences – bringing all players together for the industry – to help our community do their best work, with the smartest resources, and a group of people who genuinely care about relationships and doing good work together. Plus, we make it fun, with ice cream, videos, music, and camaraderie.

If you haven’t yet attended a 10x event, make 2019 the year you do.

We expect a completed agenda in a matter of weeks. Visit the 10x Medical Device Conference site for information and I hope to see you in May.

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The Medical Devices Group Job Board

How many medical device sales jobs do you think we presently have on the board?

How about medical device engineering jobs? And opportunities in project management?

Fact is, there are thousands of medical device jobs featured on our board, like this one:

So, if you’re looking for work, let me help.

And if you’re looking for candidates, email me back. Let’s talk about prominently featuring your jobs on the board, on this website, and in newsletters.

Let’s get those jobs filled with qualified candidates, right here among our Medical Devices Group friends.

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What We’re Talking About This Week

Kevin Bentley from Respicardia (he’s hiring) reminds us the death of the medical device tax isn’t a done deal yet and what you should do about it.

Cheryl Schaaf from Resolution Bioscience is looking for Medical Device PLM recommendations. She got some suggestions. Do you have others?

Michelle Lott has a warning about your notified body.

Got a question or need votes on a survey? Ask the community!

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Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. For those of you celebrating, a safe and blessed 🦃 Thanksgiving weekend 🦃 to you.