Sean Fenske, Editor-in-Chief11.04.19
With the last issue of MPO for 2019 wrapped up, I start to look at the loose ends that need to be addressed. While many schedules slow a little more toward the end of a year with all the holidays coming up, it makes for an ideal time to clean up the pile of “stuff” on my desk that’s grown throughout the last 12 months. During this time, I find myself sifting through notes from tradeshows, company handouts, article pitches, and other items of value that I’ve set aside to review at a later date. Well, the date has arrived.
The same could be said for our industry. Time needs to be spent planning for the next year. Both small and large firms map out their strategy, setting marketing plans, lining up new product introductions, considering regulatory submissions, and more. On a grander scale, the industry may want to take the same approach to issues that address the entire community.
Starting at the bottom of the pile, I decided to take a look back at my letter from last year’s issue, which featured my “Holiday Wish List” for the coming year. Unfortunately, while several items were addressed in 2019, they weren’t necessarily completed; we can’t cross them off the “list” yet.
Notably, device tax repeal has not happened (at least as of my writing of this letter). Neither has the critical suspension of the tax for at least another year. While full repeal is unlikely at this point before the end of the year, we’re all anxiously awaiting word of another suspension.
Similarly, reimbursement reform—another item from last year’s list—cannot be crossed off yet. While the process has seen improvements, there’s still work to be done. CMS needs to work with stakeholders to further the process along so it becomes more favorable for the introduction of new innovations that provide better outcomes for patients. The fact that the lack of an existing code could delay the market release of a potentially lifesaving technology is simply unacceptable. Changes need to occur to streamline this element of the product development process so companies have a clearer picture of reimbursement.
Beyond my list from last year’s letter, there are other areas that could benefit from gaining the attention of members of industry. Getting the lion’s share of our coverage throughout 2019 is an item also at the top of the list for 2020. That is, the planning required for a transition in the EU to a new regulatory system. MDR is slated to make its debut in May of next year. While its impact has already been felt as smart companies began preparing for the new system, an array of concerns has the industry uptight over what could happen. I think at this stage, just about everyone is hoping for a delay in implementation. Otherwise, device shortages could be a reality for the EU healthcare systems.
Tech giants entering the medical device manufacturing space is another focal point for many. While some see these entrants as new competition, clever organizations are recognizing the opportunity their presence in healthcare presents. Does your firm have technologies and products that could stand to benefit from a partnership with Apple, Google, Samsung, Best Buy, IBM, or some other tech entity carving out its foothold in this industry? If so, add it to your list as something to explore.
Speaking of technology, many throughout medtech could stand to embrace it more. For example, many firms still work on a paper-based system when it comes to their design history files, regulatory documents, and other pertinent information. If your firm hasn’t done so already, take time to evaluate solutions that will enable you to move those file cabinets out of the office. Site inspections and regulatory oversight aren’t going anywhere, so having immediate access to critical information at these times enables companies to get through these experiences much more smoothly.
Similarly, the digital world is a dangerous place. Unfortunately, medtech hasn’t fully embraced this reality and as such, has not taken cybersecurity as seriously as it needs to. Medical device manufacturers are not experts in battling hackers or computer viruses; therefore, another item to add to your list is to consider partners who can help you with those challenges. If you’re making any sort of software-based medical solution, you must address cybersecurity as part of your product development process.
Should you get to all of that, perhaps get a jumpstart on some other potential list items like determining if the industry needs a standardized communication language that all manufacturers use for their wireless medical devices. And what about artificial intelligence? Do you have product offerings (or processes) that could have AI incorporated to enhance the care provided to patients?
Hopefully, by the end of 2019, you can say you were able to cross a few more items off your list. In the meantime, enjoy the holidays and see you in 2020!
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
The same could be said for our industry. Time needs to be spent planning for the next year. Both small and large firms map out their strategy, setting marketing plans, lining up new product introductions, considering regulatory submissions, and more. On a grander scale, the industry may want to take the same approach to issues that address the entire community.
Starting at the bottom of the pile, I decided to take a look back at my letter from last year’s issue, which featured my “Holiday Wish List” for the coming year. Unfortunately, while several items were addressed in 2019, they weren’t necessarily completed; we can’t cross them off the “list” yet.
Notably, device tax repeal has not happened (at least as of my writing of this letter). Neither has the critical suspension of the tax for at least another year. While full repeal is unlikely at this point before the end of the year, we’re all anxiously awaiting word of another suspension.
Similarly, reimbursement reform—another item from last year’s list—cannot be crossed off yet. While the process has seen improvements, there’s still work to be done. CMS needs to work with stakeholders to further the process along so it becomes more favorable for the introduction of new innovations that provide better outcomes for patients. The fact that the lack of an existing code could delay the market release of a potentially lifesaving technology is simply unacceptable. Changes need to occur to streamline this element of the product development process so companies have a clearer picture of reimbursement.
Beyond my list from last year’s letter, there are other areas that could benefit from gaining the attention of members of industry. Getting the lion’s share of our coverage throughout 2019 is an item also at the top of the list for 2020. That is, the planning required for a transition in the EU to a new regulatory system. MDR is slated to make its debut in May of next year. While its impact has already been felt as smart companies began preparing for the new system, an array of concerns has the industry uptight over what could happen. I think at this stage, just about everyone is hoping for a delay in implementation. Otherwise, device shortages could be a reality for the EU healthcare systems.
Tech giants entering the medical device manufacturing space is another focal point for many. While some see these entrants as new competition, clever organizations are recognizing the opportunity their presence in healthcare presents. Does your firm have technologies and products that could stand to benefit from a partnership with Apple, Google, Samsung, Best Buy, IBM, or some other tech entity carving out its foothold in this industry? If so, add it to your list as something to explore.
Speaking of technology, many throughout medtech could stand to embrace it more. For example, many firms still work on a paper-based system when it comes to their design history files, regulatory documents, and other pertinent information. If your firm hasn’t done so already, take time to evaluate solutions that will enable you to move those file cabinets out of the office. Site inspections and regulatory oversight aren’t going anywhere, so having immediate access to critical information at these times enables companies to get through these experiences much more smoothly.
Similarly, the digital world is a dangerous place. Unfortunately, medtech hasn’t fully embraced this reality and as such, has not taken cybersecurity as seriously as it needs to. Medical device manufacturers are not experts in battling hackers or computer viruses; therefore, another item to add to your list is to consider partners who can help you with those challenges. If you’re making any sort of software-based medical solution, you must address cybersecurity as part of your product development process.
Should you get to all of that, perhaps get a jumpstart on some other potential list items like determining if the industry needs a standardized communication language that all manufacturers use for their wireless medical devices. And what about artificial intelligence? Do you have product offerings (or processes) that could have AI incorporated to enhance the care provided to patients?
Hopefully, by the end of 2019, you can say you were able to cross a few more items off your list. In the meantime, enjoy the holidays and see you in 2020!
Sean Fenske, Editor-in-Chief
sfenske@rodmanmedia.com
