Getting a new medical diagnostic to market

First, file a patent. Then get your study published by a medical journal.

How far has your research gone? Do you have results from infected patients or just from culture lines? Have you made comparative trials vs. all of the current methods?

Pharma companies will ask questions like these before they get interested in your idea, but at this early stage their support may consist simply in funding more studies. And you will absolutely need to get studies published, even before you call a pharma company, to make your idea visible.

But ultimately, adopting your method as the standard is not so much the pharma company's decision. Doctors won't routinely use it until it's endorsed by a guideline document from whatever association of infectologists publishes those guidelines, and those guidelines are only published every few years or so, at their big meetings. And they'll want to see LOTS of confirming studies before they say everyone should use it.

Whatever pharma company buys your method may also need to show the studies to the FDA before they can legally promote it.

So, congratulations for making history, and brace yourself for years of paperwork.

(Don't get too stressed. You'll laugh at it all after the Nobel committee hears of you.)

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.

My understanding as an economist is that you sell your product to some large pharmaceutical company and they get it approved.

Does this seem familiar?

If the big pharma company that buys your idea already has commercial relationships with those clinical laboratories, it might be pretty simply to get the clinical laboratory to offer the additional test if the test as FDA approval.

A lot of the competency of big pharma is that it has relationships like this and knows how to promote a product inside the system. Big pharma has competencies in bringing medical products to market that outsides to the system don't have.

A patent or a least a provisional one is likely important before you start pitching.