Technically, no. I’d be violating my NDA.
But I am happy to speak in general terms. Let’s say I have an idea to fix a problem in the hospital (I have been doing medical device most of my career). First step is to verify and give a concrete definition to the problem. This is critical, the problem is always more difficult than any solution. For example, if a hospital is not actively measuring the problem (let’s say a particular type of infection), it is not a problem. While the type of infection occurs and the patients are getting treated for it, if is not being tracked, the hospital will not buy any solution because the problem doesn’t exist. Yes, healthcare is a most effed up system.
So my customer-facing NPD group indeed determines there is a problem. You then determine the size of the problem. How much money is the hospital spending on the problem. If the market is too small, your larger companies will not generate enough revenue from it to be worthwhile. And unfortunately, the barrier to entry into medical devices is quite high. If you are not a larger company, you don’t have the capital to enter. Another reason “small” problems in heathcare are ignored.
While determining the size of the problem, the technical side is creating a solution. Where I work, we go to prototype asap. Drawings don’t show in the hospital, pretty much worthless for evaluations. Which is fine because my hot sketch capabilities are average at best. Initially, these prototypes are for show only, they do not function on a patient. But you can use them on a consenting healthcare worker to get their impressions. From this, we determine how intuitive is the solution and how much it excites the healthcare worker. Is it considered extra work or does it decrease work? Is there an obvious benefit to the patient or more importantly, is there an obvious benefit to the healthcare worker? Don’t get me wrong, helping the patient is important, but if it inconveniences the HC worker and their perceived benefits to the patient are small, they won’t do it. And if yo need a lot of education to the HC to show the benefit to the patient, it is a product less likely to succeed.
Now you have the evidence. It is a problem. It is a “large” problem. It is intuitive. It has a benefit to patient. It has a benefit to the HC worker. The HC worker is excited about the solution. You then take that data, put it into a slide deck and present to management. If all goes well, you come out of that meeting with a green light and a project number from accounting. Before that getting that project accounting number, skunkworks run off your personal PO number which pretty much limits you to purchases in the 3 figure range. The accounting project number means if you can make the case, you can cut POs in the 6 figure range. You are funded.
For us, we now get more data about the problem more directly from the clinician. In skunkworks, you may one speak to a thought leader or two. Look at the literature. Now, you are talking to multiple though leaders. Going to sites throughout the country, not just our local contacts. Going to medical conferences. Testing of solutions ramps up. Small patient evaluations that grow into large patient evaluations. Before launch, we may even start a clinical study that gets handed to our clinical research team after launch. The customer facing group and our technical group are still looking for the best way yo kill the project. Can’t be manufactured at a cost that will give of the gross profit we want. We can’t sell it at the gross profit we want. Does it have the clinical outcomes we were counting on in the skunkworks phase. Etc. Again, as we gather this information, it is presented to management, especially if we find a way to kill the project. If not, it is green lighted for launch.
After green lighting for launch, you transition out of NPD to the rest of the company. Short term costing, long term costing, product history record, DFMEA, safety testing, specifications, marketing materials, IFU, incomimg inspection plan, tooling plan, etc. After being responsible for first lot to stock, NPD is out and we move on to the next big idea.