I worked for a company that built a machine to screen pap smear slides. I got a peek into how the sausage is made at the FDA.
The associated regulatory process is a sewer of inane bureaucracy and nonsensical regulation, particularly if your shiny new method involves any computer algorithms. Let the professionals tow your device through that sewer.
Also, whether your diagnostic stinks or is great, all that really matters is getting health insurance companies to reimburse for it. You have to find stakeholder, and preferably the insurance companies, who have it in their interest to have the information your test provides. Don’t be so sure there is such an entity. Getting better diagnostics is not necessarily in the interest of anyone who counts. They may wish not to know that information.
On that score, there is a charming concept known as “standard of care”. Introduce a new test method, a better test, and now there are two “standards of care”, and that’s a big no no. You probably don’t want to be claiming more accuracy. Aim at cheaper, faster, less intrusive, more convenient, etc. Improve the cost and ease of the process, don’t aim at claims to improve outcomes, even if you do.
Having a more accurate test means squat. You need to find the business model that translates that into cash.
Teaming up with a university hospital is likely a good idea.
You really need to talk to seasoned professionals with experience getting diagnostic tests through FDA approval. Try to find similar products, and companies in similar situations. Do your market research. Identify their regulatory teams, and see if you can get in contact with the major players.
I worked for a company that built a machine to screen pap smear slides. I got a peek into how the sausage is made at the FDA.
The associated regulatory process is a sewer of inane bureaucracy and nonsensical regulation, particularly if your shiny new method involves any computer algorithms. Let the professionals tow your device through that sewer.
Also, whether your diagnostic stinks or is great, all that really matters is getting health insurance companies to reimburse for it. You have to find stakeholder, and preferably the insurance companies, who have it in their interest to have the information your test provides. Don’t be so sure there is such an entity. Getting better diagnostics is not necessarily in the interest of anyone who counts. They may wish not to know that information.
On that score, there is a charming concept known as “standard of care”. Introduce a new test method, a better test, and now there are two “standards of care”, and that’s a big no no. You probably don’t want to be claiming more accuracy. Aim at cheaper, faster, less intrusive, more convenient, etc. Improve the cost and ease of the process, don’t aim at claims to improve outcomes, even if you do.
Having a more accurate test means squat. You need to find the business model that translates that into cash.
Teaming up with a university hospital is likely a good idea.
You really need to talk to seasoned professionals with experience getting diagnostic tests through FDA approval. Try to find similar products, and companies in similar situations. Do your market research. Identify their regulatory teams, and see if you can get in contact with the major players.