There has been a long PMA drought in orthopedics. This drought has been caused 100% by the FDA, not the device company innovators.
The Most Recent Example.
The first orthopedic panel meeting since 2018 was held with Active Implants. The purpose of the panel meeting was to review the NuSurface clinical data.
The Background. Active Implants sells a total meniscus replacement, called NuSurface, in Europe. I know a bit about NuSurface, because I worked there in R&D.
With a simple outpatient procedure, these lucky Europeans get an new medial meniscus and get their mobility and pain-free life back, without any restrictions. The NuSurface meniscus implant floats on the medial side of the knee, acts as a new shock absorber and spreads out the joints forces, thus alleviating the early OA pain.
In Europe, every day a NuSurface is implanted. This innovative product serves a critical role for early OA knee patients. NuSurface buys time for patients with early OA who are in the 40-60 year old range. These patients are too old for biologic treatments (cartilage repair) and too young for total knee replacements.
For almost 20 years, Active Implants has done everything that the FDA has asked and more. Active Implants has raised a total of $133M, in pursuit of FDA clearance.
The Panel Meeting
Active Implants asked the FDA for a panel of experts that treat the targeted patent population – knee arthroscopy surgeons who are incentivized to preserve your cartilage.
Instead, the FDA put together a panel of experts made up of total hip and total knee surgeons who are incentivized to replace cartilage with TKAs. Zero knee arthroscopy surgeons were asked to join the panel. What???
Then these so-called “experts” kept trying to change the protocol after the study was completed. The FDA approved the study protocol a decade ago.
This is how the American population is being “protected”.
In conclusion, the FDA’s suffocation playbook can be summarized into five strategic steps:
1/ Relentless Demands: Continuously request additional clinical data, perpetually seeking more evidence before considering approval.
2/ Rule Manipulation: Alter the “approved” study protocol at will, introducing changes that complicate and prolong the approval process.
3/ Revolving Door: Rotate personnel within the FDA, preventing the accumulation of subject matter expertise and erasing any “institutional memory”.
4/ Slight of Hand: Assemble panel members with impressive credentials who lack a genuine understanding of the technology or the essential clinical significance of the innovation.
5/ Time Stretching: Draw out the evaluation period for an excessive duration of 10 to 20 years, draining the company of hundreds of millions of dollars.
By employing these calculated tactics, the FDA effectively stifles progress and innovation, leading to significant financial and temporal burdens on companies seeking approval for groundbreaking medical advancements.
