Every industry has its three-letter acronyms (TLAs), and certainly med tech is no exception. If you work for a big device company, you practically qualify as bilingual with the extent and array of acronyms forced into your personal lexicon. At one point I may have actually said a sentence like, “The CMO called the PI about the IRB process to estimate dates for FPI and CE mark in the PDP.”
Acronyms are popular because they serve the useful purpose of expediting communication, creating a tribal sense of community for those in the know, and conveying the (sometimes false) perception of vast expertise to the uninitiated. There are certain acronyms, however, that strike fear into the heart of the med-tech entrepreneur. Upon mention of these TLAs, the tension in the room is palpable as brains silently begin to revise development timelines, budgets and cash out dates.
Our nominations for the Top 5 Anxiety Provoking Med-Tech Acronyms (APMAs):
The only US executive branch agency more groan-worthy than the IRS is the Food & Drug Administration, particularly among med-tech entrepreneurs. At least taxation (like death) is predictable; not so with device regulation under the FDA. The length and tortuosity of an emerging med-tech company’s journey through CDRH can vary greatly by branch, division and reviewer (many of whose badges are still warm from the laminator). The US regulatory process is macabre enough for run-of-the-mill devices, let alone 21st century technologies like medical smart phone apps. Sorry, Shuren, your Innovation Pathway program just sounds vague and scary.
Back in the good old days of plentiful big-market medical devices with capital-efficient 510(k) regulatory paths, med-tech investing was a pretty good bet. But some companies pushed the boundaries of this regulatory shortcut and a few high-profile safety issues emerged (this New England Journal editorial from last fall singles out metal-on-metal hip implants). Whatever the ultimate fate of the 510(k) program, more companies will be forced down the Pre-Market Approval path, with its higher approval hurdles (safety and efficacy vs. substantial equivalence), longer timeframes, and therefore greater costs. Silver lining: more frequent flier miles from all the international travel! C’est la vie.
News of a clinical trial patient suffering a Serious Adverse Event is upsetting for emerging med tech companies, whether or not the SAE is attributable to the company’s device (and proving it’s not can be complicated). Of course, the first concern is for the patient with the SAE and their families. Shortly thereafter, though, thoughts go to the just-barely-enough money that was raised for the trial, the timeline-busting impact of halting recruitment, possibly needing to redesign the product or retest in animals, and even scarier corporate doomsday scenarios. As a clinical consulting friend once said, “If you are going to have any adverse events, get it out of the way early.”
When I first heard this shorthand for Verification and Validation, I thought it sounded kind of mysterious and even remotely sexy, even if usually uttered by a nerdy engineering type (a.k.a. our favorite clients). It wasn’t long before I realized V&V is actually a Yiddish term: “Vait! Vait!” Explaining to your investors the time and dollars required for V&V so that your QMS is ISO-compliant is just no fun. If they look puzzled, just refer them to IEC 60601-1, 3rd edition and it should all become clear.
You may have heard of a CPT code, but here’s a pop quiz for you – do you know what CPT stands for (without Googling it)? Answer: Common Procedural Terminology. Second question: what organization issues CPT codes, the all-important keys to the physician reimbursement castle? If you said CMS, you are wrong. Why, it’s the American Medical Association! And while you’d think that the premier US physician lobbying organization might be loose and generous with the codes, this is definitely not the case. If you are unlucky enough to have a technology requiring a brand new CPT, get ready for a long, arduous and likely doomed process, and start counting your RVUs.
As fear-inspiring as these and many other acronyms can be, let us not forget that med-tech entrepreneurs are a hardy bunch and not easily intimidated. Otherwise they’d be developing frivolous, benign things like Instagram. Rats.
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