Medtech a Decade Ago—A 10th Anniversary Letter

I joined the MPO team in November 2015 and began working on the brand publicly in 2016 (meaning when my first contributions appeared within these pages). It’s been 10 years now. In the spirit of my neglected “Throwback Thursday” online column (which looks back at earlier Editor’s Letters since my start in 1999 covering the industry), I thought I’d revisit those from that first year with MPO. 

In the January/February 2016 issue, which marked my debut with the brand, I offered a brief introduction and insight into my background. Following that, my focus was on the two-year suspension of the device excise tax. Thank goodness organizations like MDMA and members of Congress continued the fight for full elimination of the tax, but at that time, it was only suspended. Reading this sounded reminiscent of the concerns regarding tariffs today. Additionally, the R&D tax credit was made permanent at the same time, celebrated similarly to the innovation legislation I just wrote about in our last issue. 

In March, the focus was on direct-to-consumer (DTC) advertising put out by pharmaceutical and medical device firms. The AMA was calling for a ban on such activity as part of an effort to reduce healthcare costs. While that call isn’t being put out by the AMA today (or they aren’t getting headlines for it), the call is certainly present within today’s news cycle. Both President Trump and HHS Secretary Robert F. Kennedy have been vocal about wanting to see a DTC ban for the pharma industry. While a full ban would face legal hurdles, it was interesting to see that this has come full circle in 10 years.

The crowdfunding of medtech development idea presented in April 2016 has never gained much traction. Sure, there have been a few isolated cases, but for the most part, inventors still rely primarily on more traditional investment sources. Even the example mentioned in the Letter—the Nanoplug, the world’s first “invisible” hearing aid—seems to have stalled as there hasn’t been an update on the project since around the time I wrote the piece. 

May’s Letter offered a look at the University of Utah’s Bench to Bedside event. Birthed from the school’s Center for Medical Innovation, this still-running program partners students together to develop a medical device. Several companies have emerged from the competition, which is supported by industry through guidance and investment. If you’re not familiar with the program and may be interested in getting involved, visit the school’s website. 

June explored the use of social media as a way to promote clinical trials to enhance participation. While I’m not sure tweeting about them has gained significant traction, I have heard several experts propose the use of Facebook support groups to increase awareness of clinical trials. These dedicated groups have already gathered the target audience, many of whom are eager to hear of potential opportunities to treat a specific condition. 

As always, the July/August Letter highlighted findings obtained from preparing the Top Company reports. No surprise to anyone, M&A and divestitures were of significant note, as will likely be a substantial part of next issue’s reports this year. Additionally, the transition to value-based healthcare was mentioned as organizations claimed to be moving away from fee-for-service models. Of course, this has been slow to take place in healthcare, but many medtech firms will be prepared once it’s more of the norm.

While September’s pricing discussion didn’t have an obvious direct relevance to today’s environment, I found exactly the opposite with the October Letter. Remember Muddy Water’s allegations against a St. Jude Medical pacemaker and, specifically, the ability for it to be hacked? How far we’ve come since that time. In the past decade, the FDA has committed to a focus on cybersecurity for medical devices, making it a requirement of submissions for any device containing software. Additionally, there have since been real-world examples of healthcare facility and hospital hacks, as well as those of device maker organizations. We here at MPO have even introduced a dedicated cybersecurity column that has run in every issue for several years now. And while all of that progress is fantastic to see, according to the author of that same column, many medical device companies continue to leave cybersecurity as a virtual afterthought. Hopefully, in the next 10 years, we’ll see that mentality change. 

Wrapping up the year, the last Letter of 2016 offered a recap of lessons learned. These included a call to invest in science and not hype (a comment on the Theranos story), an update on industry spending of the recaptured device excise tax (which went into new hires, R&D, and M&A), and a request to take cybersecurity more seriously. 

I look forward to the next 10 years worth of topics.

Sean Fenske, Editor-in-Chief
[email protected]