Change is not typically something many have an easy time with. I know for me personally, it can present a challenge. The changing of clocks after Halloween, for example, can be a bit depressing as the days seem to shorten very quickly. It’s always nicer to leave the office in the daylight rather than the dark after the time change. It’s also a signal of the coming winter and the lower temperature. Fortunately, a more welcome change in spring eliminates the darkness and I once again enjoy the shining sun during my evening commute.
 
Change seems to be coming to the medical device industry as well. On the whole, we had some pretty sunny days (the ongoing 2.3 percent device tax repeal effort being one of the exceptions). Some rather negative reports of late, however, have put the medtech industry into the darkness and it could be a rather cold winter ahead.
 
Concerns began about the time “60 Minutes” aired a story about problems with Boston Scientific’s transvaginal mesh products. Although the company issued a response to the report disputing many of the show’s findings, the damage had already been done.
 
Looks like dusk.
 
Then, in the summer, a documentary called “The Bleeding Edge” was released, which highlighted several other problem medical devices, such as the Essure device from Bayer, metal-on-metal hip implants from DePuy, and vaginal mesh from J&J. The film made several valid observations with regard to the medical device industry, and unfortunately, no manufacturers appeared on camera to respond. The FDA took several lumps in the documentary as well, with criticisms of the 510(k) program as well as the regulatory review process.
 
Getting a little darker now.
 
Most recently, the results of an extensive international investigation were made public, which again did not cast a very good light on the medical device industry. Led by the International Consortium of Investigative Journalists, the effort involved more than 250 reporters from more than 50 media organizations. The findings noted that more than 1.7 million injuries and 83,000 deaths were connected to medical devices.
 
Yeah, it looks pretty dark now.
 
It may very well be a long, cold winter as the industry faces these accusations. Fortunately, as we’re well aware, the overwhelmingly positive impact of medtech far outweighs the negative news. At the same time, there is area for improvement. Change is going to come, such as in the form of the FDA’s 510(k) Modernization effort.
 
Undoubtedly, the sun will shine again for medtech. It may just be a little while and require further change. Consider that as you peruse this Company Capabilities & Outsourcing Directory. You will see a number of suppliers who are changing how they present themselves, transitioning to become true full-service providers, as we discussed at the 2018 MPO Summit.
 
I’d also like to use this opportunity to thank those who have always understood and appreciate our vision and enable us to continue to serve as the leading informational resource to so many. I appreciate our faithful 25,000 magazine subscribers and the many more online who refer to MPO to assist with challenges they encounter. Special thanks to our loyal advertisers who have believed in and supported our vision. Heartfelt gratitude to Editorial Advisory Board members—both past and present—some of whom have been mentors and friends throughout my more than 25 years in the industry. All of you share the same passion for this community and as such, share in the accolades of what MPO is today.
 
Most of all, I want to thank the best staff anyone could ask for—Michael Barbella, Pat Browne, Sam Brusco, Sean Fenske, Julie Fuhrer, and Mark Weeks, as well as our contributing writer Mark Crawford and regular columnists. Further, we could not bring MPO to the readers without the support of those who tirelessly work behind the scenes—Lisa St. Charles, production manager; Scott Garibaldi, senior designer; Richard DeVoto, circulation manager; Joe DiMaulo, audience development manager; Paul Simansky, marketing director, and his team; and Matthew Montgomery, Rodman’s executive vice president. Most importantly, MPO would not be where it is today without the support and faith of our owner—Rodman Zilenziger Jr. Throughout the years, he’s provided MPO with the necessary resources to make it the market leader it is today.
 
As we embark onto 2019, there will continue to be changes impacting our industry. The vision for MPO will proceed and I look forward to serving you as those changes require. MPO will remain true to its focus on the outsourcing relationship as our team continues to provide the most critical information to ensure your success.
 
Best wishes for a happy, healthy, and prosperous new year and I look forward to continuing our journey as we head into 2019. Undoubtedly, there will be sunny days ahead.
 
[Publisher’s Letter as it appeared in the 2019 MPO Company Capabilities & Outsourcing Directory.]