A Look into Medtech’s Future…24 Years Ago—#ThrowbackThursday

This #ThrowbackThursday article continues my look back at 25 years of covering the medical device manufacturing industry with a focus in on the Editor’s Letters from issues (and in this case, magazines, past). Hopefully, you enjoy reading them as much as I enjoy writing them and reminiscing about my former musings.
 
Into this position only a few months, finding topics upon which I could speak intelligently to was a challenge. I had already covered the potential impact of Y2K and the concept of rapid prototyping (which likely required some significant research). So what do you do when you’re already out of ideas? Lean on connections you’ve made and share their thoughts through your platform. Nothing Earth-shattering, but it fills the need for an Editor’s Letter quite nicely. But first, I had to introduce a “groundbreaking” announcement regarding the magazine.
 
A Look Into the Future Today—January 2000 issue of Medical Design Technology
 
As we start a new era in history with the beginning of 2000, Medical Design Technologyhas introduced some new features to the magazine in order to create a more effective vehicle with which to delivery information.
 
First, a little background. Don’t bother seeking out any past articles from MDT (at least none earlier than 2015 or so). The publishing company folded up shop in June 2019 and the multiple brands (and a number of my former colleagues) were abruptly shown the door. Actually, the brands were given a better send off as they were sold to other publishers. The employees were lucky if they saw final paychecks. But I digress…
 
As of this January issue, we will begin to publish the company telephone number at the end of all press releases to allow easier access to information in a timely manner.
 
I fully recognize I was likely instructed to share this information in my Editor’s Letter, but boy, could I have embellished anymore? Gee whiz, phone numbers right there at the end of the product release? Gosh, we’re not in Kansas anymore, Toto.
 
We continue to offer online reader service capabilities, in addition to the mail-in card. The Reply Online feature is accessible through the Medical Design Technology website, located at [no longer an industry website]. This will deliver your inquiry to the company via email.
 
Did anyone else read this like they were watching the hilarious “What’s the Internet” clip from the Today Show in mind or was it just me?

 
In addition, we have modified the headings at the top of the editorial pages to include our website address for easy access.
 
As much as I’d like to mock this, back in 2000, this was likely a necessity for people to realize where you were located on that wacky world wide web.
 
Speaking with the Leaders
In keeping with our focus on giving our readers vital insight into important and necessary information for this new year, I discussed forecasts and opinions with some industry leaders and asked what they foresaw as being the hot topics for the next 12 months.
 
David Anast, MPA, founder and publisher of Biomedical Market Newsletterand author of the FDA Update in this magazine, is looking for an upturn from investments on internet start-up companies. Although seeing a low in 1999, Anast predicts to see some return and reinvestment back into the medical device manufacturers industry from these companies. “Don’t expect a huge quantity,” explains Anast, “But it should be better than last year.”
 
I’m not so sure internet start-ups were reinvesting in medtech all that much. Unless I’m misunderstanding what was being predicted back then, but certainly with the bursting of the internet bubble, any spare dollars were not likely being used to invest in medical devices. If this materialized in any way, it was on a VERY small scale. Anyone more familiar with this, I’d encourage you to clarify this for me.
 
In addition, what is certainly turning into a hot topic already, Anast predicts further controversy and discussion over the topic of reuse of medical devices. In fact, for anyone interested in learning more about this debate, see his FDA Update in this issue.
 
And this debate continues today. This prediction has yet to be resolved. Although, now the discussion has branched off into other related areas, such as single-use vs. reprocessed, sustainability concerns, patient safety, etc. This one is a clear case of a long-term industry issue.
 
Linda Ruckel of the Health Industry Manufacturers Association (HIMA) addressed several topics her organization was interested in for 2000. Legislation is more a part of their agenda as she explained that Medicare reform is one of two topics that leads their priority list. Ensuring timely access to new technologies to benefit the patient is of utmost importance and seeing that Medicare coverage enables this is vital. They are also interested in seeing this success continue internationally through the establishment of a payment system.
 
Linda Ruckel was director of Public Relations for HIMA at the time, which would later be renamed to AdvaMed. Legislation is still a significant part of their focus, and enabling rapid access to patients today is still a significant effort on their agenda. Today, this relates most notably to the FDA’s breakthrough designation program and getting CMS coverage of these devices. I’ve done several editor’s letters on this topic and encourage you to read them if you’re unsure what this is in reference to.
 

• Reimbursement Debate Over FDA Breakthrough Device Designation
• Breakthrough Device Designation Reimbursement, Round 2
• Breakthrough Device Reimbursement, Round 3

 
HIMA is also interested in seeing continued implementation of the FDA Modernization Act [FDAMA], which will help to enhance the response time of the agency. This includes a streamlining of the organization and improved communication between the FDA and manufacturer companies.
 
The FDAMA of 1997 sought to modernize the agency to address the needs of the various industries under its purview heading into the 21^st century. For device makers, it addressed a number of areas, including the increase of patient access to experimental medical devices, update of off-label use rules, risk-based regulation of medical devices, and update of standards for the manufacturing of medical products.
 
Finally, Ruckel recommended we keep an eye on the smaller, entrepreneurial companies, as she sees great vision, spirit, and innovation coming from those upcoming businesses.
 
I would have loved to see a mention of some specific companies Ruckel had in mind with this comment. Who would have been on the list that’s well-established today and who would have faded away? The one company emerging on the market around this time that comes to mind for me is Intuitive Surgical.
 
Unfortunately, there could be a downside to this new year, as Alan Schwartz, president of mdi Consultants Inc., pointed out. He believes there will be much confusion over the Quality System Inspection Technique (QSIT). This new inspection policy of the FDA can be easily misinterpreted and, therefore, will likely lead to confusion on the part of manufacturers.
 
A quick glance at this portion of the FDA site has me thinking some of that confusion still exists today. With mentions of design controls, CAPA, and production and process controls, given the number of 483s still issued for these areas, it’s clear this aspect of regulation is not always clear to manufacturers.
 
On the positive side, Schwartz predicts the close working relationship between the FDA and the industry to continue. However, he believes that if the Democrats win in 2000, you can expect a tightening of the regulatory requirements that are currently in place.
 
Well, the Dems didn’t win in 2000 (not about to revisit that mess), but the relationship between industry and FDA has improved significantly. Today, I hear more compliments thrown at the FDA for being open and willing to work with manufacturers. That said, I have no doubt there are still nightmare stories out there and people who are dissatisfied with decisions the agency has made, but I hear far more positive things these days that I did years ago.
 
As you know, in the medical device manufacturing industry, immediate access to information is critical. We hope this information, as well as the new changes to the magazine, will assist you as we move forward into 2000. I hope you all enjoyed the holiday season and now request you join me in embracing the new millennium.
 
Those who want to explain to me why 2000 wasn’t really the start of the new millennium and rather, it started with 2001, don’t bother. I heard this argument many times over 24 years ago. No one cared then either.