How To Become a True Medical Device Quality Professional

I was talking to Jon Speer from Greenlight Guru about how to become a true quality professional.

He shared, “I have a choice and the choice is purely up to me. I can choose to be status quo and be a checkboxer or I can elevate my game and focus on becoming a true quality professional.” Here’s a short video of our conversation.

Jon is giving a two-hour workshop, “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” April 3rd, 2018 at the Meadowlands. You can get the brochure on our homepage.

Click for the transcript. »

Medical Device Events : Live Webcasts vs Recorded, Downloadable Video

Michael YonchenkoGuest post from Michael Yonchenko who has many years of experience in medical device events recording and communications and who will be recording the 10x Conference in Minneapolis this year.

In the 1980s many of my medical device and pharma clients asked me to produce marketing videoconferences live-via-satellite.

These live events were “narrowcast” to predetermined locations in many cities around the country. The defined audience was potential buyers of my clients’ products. The content for these programs was well-defined and presented. Audience members could interact with the presenters via phone lines. Many, but not all, resulted in meeting intended goals and objectives.

These were very expensive programs to produce. Unless the cost of the program was +/- $100/participant there would not be a justifiable ROI. Videoconferencing was often just an exciting corporate communications fad. Marketing executives had found a fill and needed it.

The Four Criteria Before You Spend The Money. »

New Medical Device Innovation Consortium aims to streamline development processes

There’s a new player in the game for medical device development in the U.S.: The Medical Device Innovation Consortium.

The U.S. Food and Drug Administration, under criticism from the medical device industry for its burdensome review process, announced last week its intention to collaborate with private companies through the consortium. The new nonprofit is intended to find, test, and implement new ideas.

This comes as good news for medical device innovators, some of whom have begun launching their cutting edge products in Europe rather while waiting for approval to enter the U.S. market.

The impetus for the Medical Device Innovation Consortium (MDIC) came from LifeScience Alley, the largest state-based life sciences trade association in the U.S. The Minnesota-based group includes Medtronic, St. Jude Medical,  Mayo Clinic, Boston Scientific, Cargill, and the University of Minnesota. LifeScience Alley worked with the FDA’s Center for Devices and Radiological Health (CDRH) to develop the new non-profit organization. Dr. Maura Donovan, who has been vice president of therapy research and development with Medtronic, has been loaned by Medtronic to serve as interim executive director for the MDIC.

The Medical Device Innovation Consortium will function in the pre-competitive medical device research space, with initial objectives focused on the creation of scientific tools to assist stakeholders in developing and assessing the safety and effectiveness of new medical device products.  The ultimate goals of the MDIC are to enhance the quality and performance of medical devices;  improve the timeline of availability of these products to patients; and validate and qualify new methods, tools, approaches and standards in order to increase transparency and effectiveness for industry stakeholders.

— Dec. 3 announcement from LifeScience Alley

All the comments we’ve seen about the new consortium are cautiously optimistic. Its success would mean some very positive change for the medical device field. You can bet we’ll be hearing a lot about it at the 10x Medical Device Conference in April.

The Medical Device Industry’s Gearing to Go Faster, Further — Are You Ready?

This is no time to take a “wait and see” position in the medical device industry. Just this week the FDA announced the formation of the Medical Device Innovation Consortium, a unique public-private partnership designed to simplify and speed the development and review of new medical devices in the U.S.

At the same time, international mergers and acquisitions in the medical technology field are happening at a record-setting pace.

At the 10x Medical Device Conference, April 29-30 in Minneapolis, we’re going to tackle these topics and more.

Learn about the upcoming 2015 10x Medical Device Conference to be held in San Diego, May 4-6.

We’re developing a lineup of international speakers and panelists who’ll share their experiences and insights about how companies can bring medical devices to market, rapidly and profitably. We’ll have Ames Gross of Pacific Bridge Medical talking about more than 20 years of experience with medical device manufacturing in Asian countries. Linda Rouse O’Neill of HIDA will share her experience representing the medical device industry with federal agencies and legislators, and Mario Martinez of Tecnix, LLC, will talk about the establishment of medical device distribution and manufacturing operations in Latin America and the U.S.

If you’re looking to accelerate the growth of your medical device company, consider joining us in Minneapolis this April.