Can you name the five steps to market required to move your product from concept to launch?
Obviously, we’re talking at the 50,000 foot level, not the fine detail of the FDA submission and commercialization processes, which can be lengthy.
Let’s start with the first step – Define the Product – because it’s a bit more complicated than it sounds.
Well, that, and because it’s the first step. ?
Defining the Product is not just a matter of deciding that your product is a thermometer, or an implantable device, a surgical mask or an infusion pump.
First, and above all else, you need to determine the Intended Use for the product.
The Intended Use refers to the objective intent (or purpose) of the product and sets the stage for determining the applicable FDA regulations.
Here’s an example of a clear Intended Use statement:
Intended to provide intraosseous access in patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases.
The Intended Use is typically part of your labeling, advertising, oral and/or written statements, and implied or expressed claims.
You need to be very careful when crafting your messaging, because the Intended Use is usually what trips manufacturers making grandiose claims about all the wonderful things their product can do.
You know the ones I mean…those fantastic products that can cure most anything from eczema to constipation to coronary artery disease. ?
Spoiler alert: FDA doesn’t like that, and won’t let a claim like that slide without evidence. A LOT of evidence.
Conversely, the Indications for Use defines the target population, the duration of use and the anatomical sites where the product can be used.
It is NOT the same thing as the Intended Use, but it does fall under the same umbrella.
Here’s the Indications for Use to go with the Intended Use statement above:
In the proximal tibia, distal tibia and humeral head (proximal humerus) of adults and pediatric patients, and the distal femur in pediatric patients patients for up to 24 hours.
See the difference?
The second of the five steps to market – Verifying Your Product is a Medical Device – is actually somewhat straightforward, as long as you are crystal clear on what it is your product does.
According to Section 201(h), a medical device is an “instrument, apparatus, machine, implant, in vitro reagent, including component, part, or accessory” that:
• Diagnoses, cures, mitigates, treats, or prevents a disease or condition
• Affects the structure or function of the body
• Doesn’t achieve it’s purpose as a drug
• Excludes certain software functions (data storage, administrative support, electronic patient records and the like)
Let’s try a few examples:
I think we can all agree that a table lamp does NOT qualify as a medical device.
But what about those “sun lights” that promise to help you “regain focus on concentration”?
Like a table lamp, these lights are compact, easy to move from room to room, with a modern design and (most likely) an LED bulb.
But unlike a table lamp, a sun light is intended to provide natural spectrum light to help combat depression.
Depression = disease = medical device
How about diapers? Baby diapers are designed to protect garments from urine and stool – pretty easy, right?
But what about adult diapers? Also designed to protect clothing from urine and stool, but these DO qualify as a medical device.
Why? Because adult incontinence is a condition (or the result of a disease, take your pick) and therefore the diapers – which mitigate the condition – fall under the definition of a medical device.
Your homework assignment is to write a complete explanation of why your product is or is not a medical device. This will NOT be graded on a curve. ?
Ready to move on? Check out Steps 3 + 4 here: https://leanraqa.com/the-five-steps-to-market/
Or learn about the Top Regulatory Mistakes you need to avoid at all costs: https://youtu.be/RRQT5nOSD8g
