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How To Become a True Medical Device Quality Professional

3 min reading time

Reading Time: 3 minutes

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.

Joe Hage: Hey, it’s Joe. I’m here with Jon Speer from Greenlight Guru. Hey Jon. Jon, you talked about a checkbox mentality. What exactly does that mean and what’s the alternative?

Jon Speer: A checkbox mentality is somebody who’s just going through the motions.

They’re just trying to check a box and make sure that they’ve satisfied what the regulatory bodies, the ISO auditing groups, FDA, what they think that they want. So, they’re not really interested in what the content is or what the process is, they just want to check the box.

A true quality professional is someone that rises above just checking a box on the form and understands why these changes are important especially for the patients who are going to receive our medical products.

Joe Hage: Thank you, Jon. What does the EU MDR look like for a checkboxer versus a true quality professional?

Jon Speer: I want to start with the true quality professional: Let’s give people the best possible outcome of shifting their mindset and the true quality professional gets ahead of the situation.

They don’t wait for it to happen to them and with the changes in EU MDR; the checkboxer is gonna wait.

The true quality professional is being proactive. They’re reaching out to the notified bodies. They’re intimately involved in trying to understand what is changing about the regulations in Europe and how that impacts our products and they’re trying to make sure that they understand not only what the regulatory bodies need but also what is important to the patient.

Now the checkboxer, maybe not so much. They’re not putting any value in it and the thing about that is, when you take that approach, a year from now you’re going to have to update your technical files, the documentation that’s important for the EU CE mark process, which is a big part of these MDR changes.

If you just check the box and you got no value out of that you’re going to go through that step again, you’re just going to check a box again and again and again. You’re going to get burnout as a medical device professional and your products aren’t going to improve.

Joe Hage: Great answer thank you. How can Greenlight Guru help the true quality professional?

Jon Speer: I care very much about patients. I believe wholeheartedly that the reason I’m here on this earth is to help improve the quality of life and that could be through a number of ways.

What we’ve done at Greenlight is we’re helping the medical device professional, the true quality professional, because we built a software platform, an eQMS software platform, that addresses compliance, because you still have to deal with the compliance, but we’ve taken the guesswork out of the equation for the true quality professional.

Now, the content, the information they capture, that they document, in Greenlight’s “Go-and-Grow” products is a single source of truth that allows them to make better-informed decisions about ways to improve their products, that allows them to make better-informed decisions about ways to improve their products, their processes, their technologies so that, in the end, the patient’s life will be impacted for the better.

Joe Hage: You are consistently one of our highest-rated speakers. I will see you at MDTX, and… Give me a high five!

This broadcast was brought to you by MDTX, the Medical Device Technology Exchange. Meet me and Jon Speer at MDTX, April 3-5 in Secaucus, New Jersey, at the Meadowlands where Jon will present “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” a two-hour workshop, April 3rd at the Meadowlands.

See you there!

Medical Device Events : Live Webcasts vs Recorded, Downloadable Video

3 min reading time

Medical Device Events : Live Webcasts vs Recorded, Downloadable Video

Reading Time: 3 minutes

Michael Yonchenko

Guest 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.

New webcast applications have become more reliable and easier to use. And like the videoconferences of the 1980’s many are simply not a worthy investment. Often, presenters do not consider four essential criteria that must be met if their live webcast is going to be effective and meet their desired goals and outcomes.

These criteria have not changed since the videoconferencing in the 1980’s. If all four criteria are not met, it is likely that there is another communications technology that will be more effective. The criteria are:

  • The information presented must be time-sensitive.
  • The program needs to presented to a large audience.
  • This audience must be geographically dispersed over a wide area.
  • The audience must have the opportunity to interact with the program presenters.

Many marketing webcast presenters believe that webcasts reduce the need for corporate travel. However, there are often situations in which more can be accomplished in a face-to-face meeting than can ever be accomplished via a webcast. Executives often like to travel to see their colleagues or to meet directly with their clients.

Live webcasts users are locked into a viewing schedule that may be inconvenient. Would you watch a live webcast rather than attend a required senior management meeting? Not likely.

Very few webcasts take advantage of the powerful use of the visual technology that is available to them. Short video segments can take the viewer to places they otherwise cannot get to and show them things that they otherwise cannot see.

For example, what better way is there to demonstrate the mechanism of action of a drug-eluding stent than through the use of an anatomical animation? Too many medical device events produce webcasts presenting speakers who use poorly produced PowerPoint slides. The speaker drones on while reading the huge volume of print in each slide. You can listen to this webcast rather than view it and the effect will be the same.

However, a short, well-produced downloadable video that can be viewed at anytime usually accomplishes a great deal more than a live webcast that is not well-produced or doesn’t meet the criteria listed above. And don’t forget the printed word! There is no denying that a simple brochure or white paper can still be an effective means of communication.

Take a dispassionate look at your communications goals and objectives, the real cost of reaching your audience, and the most effective use of the available communications technologies. Beware of the fill. You may not need it.

About The Author

Michael Yonchenko, Founder and Co-Principal of Cogent Communications, specializes in the production of video, multimedia, and live events exclusively for the medical device and pharmaceutical industries. Early in his career, Michael was a head of the Division of Instructional Media at the Stanford University School of Medicine where he wrote, produced and directed video training programs and worked in the development of live videoconferences via satellite. In 1981, Michael formed Cogent Communications to produce programs for the medical device, pharmaceutical, and other health-related institutions. Cogent CommunicationsCogent has won 80 national and international awards including the 1996 C. Everett Koop, M.D. Award for Best Medical Education Program from the American Medical Association. For more information go to http://www.cogentcomm.biz.

New Medical Device Innovation Consortium aims to streamline development processes

2 min reading time

New Medical Device Innovation Consortium aims to streamline development processes

Reading Time: 2 minutes

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.