A good friend of mine is a consultant for medical device companies who are trying to get their products through the FDA. She knows how to compile all the research information, write accurate product papers, and consult the right medical experts in order to get the product approved by the FDA.
She has multiple medical experts to choose from and they act as clinical consultants for her at all different stages of the product development. Herself, she has a masters in biology and is already charing north of $150/hour.
She worked with a company for 5 years where the CEO was petitioning FDA approval for a product previously approved in EU markets. This device was meant to noninvasively drop a patient’s core temperature.
During her 3-year stint at that company she communicated with the FDA to figure what information and clinical trials were needed. Then she brought on medical experts who were ER doctors and Anesthesiologists to help design the proper testing for that product.
She then contracted a research lab, set the proper guidelines, designed the experiments, and communicated the necessary changes with the engineering team. Throughout this process she would email or call the clinical experts who charged her pretty penny for their time.
The Medical Expert
A medical expert can approve and validate clinical data.
They can consult on clinical applications.
They can design testing or research protocols.
Or they can evaluate and approve existing protocols.
A medical expert can be hired by a company in order to review clinical evidence and see if such new information is clinically applicable.
Or they might be consulted by investors to see if a medical startup is worth investing in. This expert will need to have in-depth knowledge about their field of expertise and be known by word-of-mouth.
A medical expert is often a physician but. not always. Sometimes it’s an RN, an NP, or a PA. They could be with or without an active medical license specializing in a specific topic.
You might be a cardiologist who is an expert in EKG’s.
More specifically, you are an expert in testing the accuracy of EKG’s.
More specifically, you are an expert in portable EKG’s.
Finally, you are a medical expert in direct-to-consumer EKG devices.
The medical expert needs the following characteristics:
- have published work under their name
- affiliated with major research institutions
- have patents pending or approved
- experience consulting on devices or treatment protocols
- a broad network of connections with research labs and other medical experts
You don’t become a medical expert overnight. You have to start somewhere and the most important first step is to figure out what you’re interested in. All the stuff from the list above is the natural consequence of playing this consulting game.
You don’t have to be a cardiologist to be an expert in EKG’s. And you don’t have to be an anesthesiologist to consult on outpatient dental anesthesia devices. You can be a family medicine doctor consulting for telemedicine companies or a PA consulting for hospitals trying to design treatment protocols.
How do you start doing clinical consulting? Most of us are medical experts in one thing or another, if for no other reason than pure interest. But this is just the start and we need to build on that in order to earn money from it.
Who needs clinical consulting? Damn near any large industry will need clinical consultants. A huge industry is workplace safety. Another is direct-to-consumer product development. Telemedicine is a hot one right now.
Even if a product is already successfully on the market, the manufacturer may want to extend its use through the FDA. Maybe they want to make cost-saving tweaks to it. Or perhaps another country wants to use that product in their own market.
Working with Engineers
Before the engineers can get down and dirty, they will need to run things by the clinical consultant. This is the medical expert who can take scientific data and translate it to the use on a human being.
A clinical consultant needs to understand the limitations of a medication and understand the common noncompliance of a patient. They need to understand how common medical problems or other medications might interfere with a new intervention.
Being able to communicate with the engineering team and the CEO of a medical device company is very important. Though, most often, you’ll have only one point of contact who is usually the lead project manager in the medical affairs department.
Breaking into the Field
As I mentioned, it’s helpful to figure out what you’re interested in. Let’s say you are interested in STI’s. Maybe you have a good understanding of various sexually transmitted infections and how they affect patients, how to best test for them, the incubation periods, and treatment strategies.
Or maybe you are interested only in Gonorrhea and its rising resistance to antibiotics. You can get very specific which actually might make you an even bigger topic expert.
You need to start writing for journals, magazines, online websites, and maybe even start your own newsletter or blog to demonstrate your knowledge in the field.
Medical experts aren’t always easy to find and companies rely on word of mouth.
Start getting your hands on every single research paper about a particular topic. Collect them on a blog or a website and write summaries of each. Discuss the limitations.
Connect with others.
Find the person who is the current sought after clinical expert in your field and follow their work.
Undoubtedly, they will have a particular area of interest within that topic and you can try to piggy back off of them or develop your own niche. Read everything they write and listen to everything they say.
There is no school for becoming a medical expert. There is no degree you get and no licensing body which will deem you a medical expert on Gonorrhea.
You need to market yourself by reaching out to pharmaceutical companies, medical device companies, device testing labs, hospital ID committees, and STI clinics. This is how you’ll learn about what you don’t know. This is how you get your name out.
If there is a lab or a research company which is already working on a particular product, attempt to collaborate with them. This is a great way to get your name out there.
Offer to review various research papers or provide a second opinion on the product in question. Suggest improvements and expanded use possibilities.
If you’re starting out in the STI field then try to branch out because you may not know where there are knowledge gaps in the market.
Get on an IRB or ethics committee. See what products and research fields are in highest demand.
Start broad and narrow down with your clinical expert topic. For example, if it’s about Gonorrhea and antibiotic resistance then start by giving lectures at medical schools and residencies about STI’s in general.
Then advertise your services to CME events. These are often quite saturated but it’s a good way to make connections.
Contact a medical startup company and see if they would like to have you give them a lecture on a particular topic.
Look for the “medical affairs” department.
Once you feel that you are more knowledgable in a particular field, look up a particular drug store item and find out which company produces it.
Then reach out to their medical affairs department and ask if they need a review of the clinical profile of the product. You can review the clinical data they already have or you might get the opportunity to suggest a better way of assessing the clinical profile of the item.
Earning an Income
The going rate for a medical expert is somewhere in the $200/hour range. Much higher when you have a good pedigree established. And you can earn this income from your PJ’s or from a beach in Thailand.
My friend pays her anesthesiology medical experts $400-$1,200 per hour to design her research studies. She uses the cheaper doctors first to get the rough draft figured out and then has the pricier doctors review the work and provide any final tweaks. She definitely does most of the work and these doctors are used as medical experts.
You have to set your prices and you cannot be timid about this. The recommendation in this industry is to start charging what you’d normally make as a clinician, if not slightly lower.
The common complaint in the industry is that doctors expect to earn more than they earn as clinicians for providing nothing but knowledge.
4 replies on “Becoming a Medical Expert for Clinical Consulting”
I’m not a medical doctor, but I do have a PhD and I work in pharma developing medical devices.
you have a large number of factual errors in this post. Feel free to reach out off the blog if you are interested in correcting them.
For example, current regulations in Europe mean that medical devices are not “reviewed” as they are in the US and other countries. European regulations only require self certification (CE Marking), and there is no “approval”.
Also, Countries don’t request products be marketed or approved. Manufacturers want to introduce products to market.
This is great Jason, thanks for clarifying the information. That’s why blogs are wonderful, they come with built-in fact checkers.
I think a post like this is good for general advice as to how to approach the topic of becoming a clinical consultant but the details might be lost on many readers. Getting into the notified bodies which the EU uses and ISO 13485 guidelines and shift towards MDSAP would bloat the post further. Most of my posts are bloated anyways so maybe leaving the details out might serve as a factual diet.
But Jason stands corrected, there are likely a large number of errors in this post as far as the details are concerned regarding the FDA and how they view “devices” and medications and the EU and their 3 separate regulation bodies. If you are interesting in consulting in this space then you need to learn all them goodies on your own. And then hopefully come back and share that with me here or you’ll be writing crushing posts on the topic on your own blog.
Jason, if you find any other errors worth corrected please share them with the readers. I hope that my future revisions of this post will be more accurate.
I agree, it is a balance. I’d be happy to consult for you to further improve accuracy…
(LOL KIDDING!, It really isn’t proper for me to consult for pay given my employment status)…
The information I’ll get from talking to you for an hour will likely be worth thousands of dollars. Even if you charged me $500 for an hour of talk-time, I would save money because it would likely take me several weeks/months and many more hours to find similar information, not even knowing if that information is accurate.
We definitely need to chat at some point in the future but I got some learning to do still; otherwise I’ll just sit there drooling and picking my nose on the phone.