The DxMA Summit’s agenda will complement EWC’s and will explore disruptive technologies likely to be of great interest to medical laboratory leaders and pathology groups

Cybersecurity, wearable technology, and social media are the primary trends facing in vitro diagnostics (IVD) manufacturers and clinical laboratories.

That’s according to Debra Harrsch, President-elect of the Diagnostics Marketing Association (DxMA), a self-funded organization devoted to helping diagnostic marketing professionals stay abreast of industry trends and effectively navigate the changing legal, regulatory, and technology landscape.

DxMA will be holding its annual Global Marketing Summit April 30-May 1 at the Sheraton New Orleans Hotel on Canal Street. Coincidentally, the 2017 Executive War College (EWC) will takes place in the same venue, May 2-3, directly following the DxMA summit.

The DxMA relocated its annual meeting to coincide with the EWC because of the synergies of the two organizations. Both of their members will have the opportunity to expand their understanding of trends happening in the IVD/clinical markets, marketing techniques, reimbursement, and regulatory issues, while having the opportunity to network. The DxMA provides laboratorians and pathologists a unique insight into disruptive technologies as well as marketing techniques.

“The collaboration between DxMA Summit and the Executive War College is an important development for both clinical lab professionals and the IVD manufacturers that serve them. We are bringing together lab leaders with their marketing and business development counterparts from the IVD industry. This increases the opportunity for attendees to advance their knowledge about key trends, network, and pursue business opportunities,” stated Robert Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College (EWC).

Previous DxMA Summits covered regulation and reimbursement topics. Harrsch noted, however, that those areas will be thoroughly addressed at the EWC. Thus, DxMA plans to dive deep into disruptive technologies and marketing trends affecting the diagnostics industry, which should interest pathologists and medical laboratory leaders.

“Topics that diagnostics companies and IVD companies face, the clinical lab directors also face,” said Harrsch in a phone interview with Dark Daily. Harrsch also is President and CEO of Brandwidth Solutions, LLC, a full-service marketing agency that assists companies with branding to social media to launching a new product within the life science, healthcare, pharmaceutical, and energy industries.

“IVD manufacturers are responsive to what is happening in the hospitals and clinical labs, and lab directors and pathologists want to learn what is on the horizon as well as how to market their services. The co-locating of the DxMA Global Marketing Summit and the EWC provides an outstanding forum for both,” Harrsch said.

Cybersecurity for IVD Companies, Clinical Laboratories

Cybersecurity is a new priority for diagnostics companies and labs, Harrsch said. Medical devices—like other computer systems—can be vulnerable to security breaches that potentially impact their safety and effectiveness. That’s according to the US Food and Drug Administration (FDA), which in January issued a safety communication confirming vulnerabilities found in St. Jude Medical’s implantable cardiac devices and associated Merlin@home transmitter.

“The FDA has confirmed that vulnerabilities, if exploited, could allow an unauthorized user to remotely access a patient’s implanted cardiac device by altering the Merlin@home transmitter,” according to an FDA statement. The agency also recently released Final Guidance on “Post-Market Management of Cybersecurity in Medical Devices.”

Debra Ann Harrsch (above) is President-elect of the Diagnostics Marketing Association (DxMA) and President/CEO of Brandwidth Solutions, LLC. The DxMA is hosting its 2017 Global Marketing Summit just prior to the 2017 Executive War College at the same venue in New Orleans. Disruptive technologies such as cybersecurity, wearables monitoring devices, and social media, are on the agenda to be discussed. The DxMA has scheduled a cybersecurity panel discussion at 12:15 pm, May 1, for the convenience of early-arriving Executive War College attendees. (Photo copyright: Brandwidth Solutions.)

Debra Ann Harrsch (above) is President-elect of the Diagnostics Marketing Association (DxMA) and President/CEO of Brandwidth Solutions, LLC. The DxMA is hosting its 2017 Global Marketing Summit just prior to the 2017 Executive War College at the same venue in New Orleans. Disruptive technologies such as cybersecurity, wearables monitoring devices, and social media, are on the agenda to be discussed. The DxMA has scheduled a cybersecurity panel discussion at 12:15 pm, May 1, for the convenience of early-arriving Executive War College attendees. (Photo copyright: Brandwidth Solutions.)

The FDA is encouraging organizations to develop a comprehensive risk program—reflecting the National Institute of Standards and Technology (NIST) framework—to strengthen critical infrastructure cybersecurity, explained a FierceHealthcare article.

And a Reuters article reported that Johnson and Johnson discovered security vulnerability in one of its insulin pumps as well, making it possible for a hacker to give people an overdose of insulin. No known attacks occurred, nevertheless, the company issued a warning to its customers.

“We’re not just talking about hacking the billing system any longer,” Harrsch stated. “When people can hack in and change a person’s insulin pump just because they can, that’s a problem. And it’s a problem for everyone to be concerned about—the IVD manufacturers as well as laboratorians.”

Therefore, one of the DxMA summit sessions will cover everything lab leaders need to know about the topic. Titled, “Cybersecurity for Manufacturers and Labs,” the session will be presented by:

Jim Jacobson, Chief Product and Solutions Security Officer at Siemens Healthineers;

William Clark, Cybersecurity Strategic Consulting, North Americas Lead, Computer Sciences Corporation (CSC); and

Suresh Mandava, Associate Partner and Business Leader for Cybersecurity Strategic Consulting (North America) at CSC (NYSE:CSC).

Wearable Monitoring Devices

The DxMA identifies wearable medical monitoring devices as another important trend that is already impacting clinical laboratories and pathology groups.

“We are all keeping track of our health with our smartphones,” Harrsch notes. “We are counting steps, monitoring stress, checking our heart rates, and more by using smartphones.” These are “early days” for wearables’ impact on the clinical market, she adds. But the time is right for manufacturers and labs to hear about the technology’s evolution. “Where do [IVD companies and clinical laboratories] want to fit in the food chain? For me, I want to know what is likely to happen five or 10 years from now.”

As Dark Daily recently reported, new wearable fitness gear enables:

• heart rate tracking;

pulse oximetry readings;

lactic acid tracking; and

• tracking of other biomarkers usually associated with the hospital or medical lab.

However, wearables for medical monitoring face obstacles, such as:

• reimbursement by insurers;

• processing and analysis of data; and

• uncertainty about external effects on data that could be leveraged for care.

One DxMA Summit session that will delve deeply into these challenges is:

• “Disruptive Technologies” by Greg Tsongalis, PhD, Professor of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center Geisel School of Medicine.

Social Media for IVD Manufacturers, Medical Laboratories, Pathology Groups

Social media’s influence on diagnostics manufacturers and clinical laboratories is another important issue today, Harrsch noted. But what can a lab director or pathologist do about social media? Harrsch advocates “thought leadership” as opposed to promotion of services. For example, the pathologist could reach out to primary care physicians who might seek an online expert for advice on tests to run concurrently.

“It’s about getting the word out and making yourself a thought-leader,” said Harrsch.

In another social media approach, the University of Pennsylvania Health System (Penn Medicine) is leveraging data from platforms such as Facebook and Yelp to improve patient experiences and more, according to a FierceHealthcare article.

The DxMA Summit will feature an important session on the topic titled, “How to Get the Most from Social Media In Your Marketing Mix,” presented by Jared Tipton, Executive Director, Corporate Communications; and Darwa Peterson, Senior Marketing Communications Manager; both with Cepheid, a manufacturer of IVD and other healthcare diagnostic technologies.

Organizers Offer EWC Attendees Incentives for Summit Attendance

DxMA’s Summit, conducted since 1978, begins this year on April 30 with the Dx Creative Awards Dinner and Presentation, and on May 1st, the Global Marketing Summit kicks off at 8 am. Online Summit registration is available through this link. Special rates are offered to Executive War College registrants who provide a copy of the Executive War College registration at the time of Summit sign-up.

The Executive War College is the country’s pre-eminent gathering of lab leaders and innovators. It offers information on regulation, reimbursement, technology, and marketing for the clinical laboratory industry. Online registration and more information about the Executive War College are available through this link.

—Donna Marie Pocius

Related Information:

Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication

FDA Issues Final Guidance on Post-Market Management of Cybersecurity in Medical Devices

FDA Lays Out Post-Market Medical Device Cybersecurity Recommendations Final Guidance

FDA Device Guidance: Start with NIST, Cyber Framework

J and J Warns Diabetic Patients: Insulin Pump Vulnerable to Hacking

Q and A: Penn Medicine Researchers Mine Patients’ Social Media Data to Improve Engagement

Improvements to Fitness Wearables Help Stream Data from Consumers to EHRs and Clinical Pathology Laboratories