One word used much too loosely in life science and medtech innovation.
Life science innovation including medical devices is unique in its rigors and impact. It happens in a highly regulated environment for safety, and it has highly unique nomenclature. You’ve probably come across some of this before: IRBs, investigational device exemption, PMA, 510k, significant risk versus non-significant risk… the list is nearly endless.
There’s one word that gets thrown around much too casually in life science and medical device innovation, especially for startups and early growth stage companies.
A serious landmine in the lexicon is labelling. From Cornell Law, “Labeling is a formal term defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act). It encompasses all labels and all other written, printed, or graphic material that either appears on the device or its packaging, or accompanies the device at any time during distribution. In practice, this includes the device’s label, packaging, instructions for use, manuals, patient brochures, and even certain promotional materials provided with the product.”
Via CRSToday, FDA uses the term “market” to mean legally offering the device for sale in the United States, which requires prior FDA clearance, approval, or exemption for the device’s intended use. According to Eliquent Life Sciences, “Many forms of advertising and promotion are regulated as promotional labeling, meaning FDA often treats marketing content as a subset of labeling for oversight purposes. Thus, while “marketing” in industry means promoting and selling a product, under FDA scrutiny it intersects heavily with labeling regulations.
The one word that gets used much too loosely: it’s “marketing.”
At some point in the commercialization pathway for a medical device startup or early growth stage company, an advisor, investor or colleague will tell you that you need to invest in marketing. When that happens, stop. Stop immediately and ask, is it marketing you need or do you need to build awareness?
What’s the difference between marketing and awareness for medical device innovators? The difference is huge. Awareness means just that. Making people aware of your entity, it’s goals, endeavors, how the entity and usually the technology meets the unmet clinical need. Building awareness means using content in all of its types and venues to inform, engage, build trust and enable sales when you have an FDA cleared or approved device on the market to sell.
How can you use both effectively to accelerate milestone achievement and reach your next inflection point or funding round? I’m looking forward to unpacking that with some colleagues in a webinar a little ways down the road. In the meantime, I welcome your thoughts. Email PDSnyder@kavucommunications.com
