The success of new year’s resolutions for 2023 won’t be known for months to come, but from the vantage point of December, it is easy to see that many large med-tech companies resolved to shed excess weight in 2022 – and did so in dramatic fashion. Some big-name players decided that they would be more agile, and better rewarded by shareholders, with a trimmer portfolio, while others saw value in setting internal operating units free as new companies.
With many of the big names in med tech focused on streamlining their portfolios and spinning off divisions as independent companies, M&A activity sputtered through most of 2022. As the year comes to a close, however, deal volume has increased, with a strong trend toward acquisitions of closely related companies and units that bolstered higher-growth product lines and offered short cuts to filling in significant gaps in portfolios.
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders.
The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers.
After a flood of deals with special purpose acquisition companies (SPACs) that took dozens of med-tech and biotech companies public in 2021, deal flow slowed to a trickle in 2022. Market conditions factored into the collapse of interest, but regulatory changes also played a significant role. Still, several notable companies made their market debuts via SPACs in 2022 – and one changed its mind mid-stream.
The fifth medical device user fee agreement (MDUFA V) included several new programs, such as a program intended to aid device makers in an efficient to-market process. However, MDUFA V also boosted device user fees for many applications by 55% but turnaround times for these applications will remain essentially flat compared to MDUFA IV.
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
The CMS had floated a coverage concept for devices routed through the U.S. FDA breakthrough devices program shortly before the Biden administration took office, but the change in administration proved lethal to the program in terms of its initial contours. The latest development in this saga would have the program revert to an expanded use of the existing Medicare coverage with evidence development (CED) program, a far cry from the original concept of same-day coverage upon FDA approval or clearance of the device.
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. And research into the drug class is continuing apace.
In 2022, neuroscience research made significant advances by understanding the role of large-scale neuronal connections in disorders. So did cancer research.