If my goal is to open a lab, whats better, PhD or MD/DO/DPM

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VEGETAbale

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So Im currently a CLS and have a year of experience. I want to open my own lab so I looked into the requirements and found a PhD can operate a high complexity lab just the same as an MD/DO/DPM, so Im going to pursue one of those degrees. My question is if my lab is going to be doing clinical diagnostic testing which of those professionals would providers be more inclined to send samples to? would they even care? could I do this kind of diagnostic testing with just a masters? Is routine lab work considered moderate or high complexity?

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MD/DO/DPM and PhD are all entirely different training paths.

If you want to run a lab doing diagnostic testing, the best thing you could do is talk to the person who runs your own workplace and ask them about what it takes (and what credentials you might need) to get into their position.

A PhD is expected to produce original research, which means coming up with a way to advance a particular field in conjunction with your PhD advisor. After you finish the PhD, which is typically 5-7 yrs in the life sciences, you typically have to complete at least one postdoc before you can apply competitively for jobs. A lot of jobs in industry allow you to do something to the effect of what you describe, but in the context of drug and/or technology development moreso than healthcare delivery.

an MD or DO will be 4 yrs of medical school where you will learn clinical medicine with the expectation of completing a residency and becoming board certified. It sounds like you would be interested in entering a field like Pathology or Radiology where you do not necessarily see patients directly but might run a service which provides diagnostic services to other physicians and healthcare providers. I don't know anything about DPM so I can't comment on that, although you should know that everything they do is related to podiatric health; i.e. feet.

From what you say, if further training in MLS or CLS is not ideal (for example, like an MS in CLS or diagnostics or something), it sounds like an MD/DO followed by a residency in Pathology would be closest to what you describe if you want to run the service. I'm not too familiar with PhD jobs in this area but there might be a way to do it as a PhD.
 
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MD/DO/DPM and PhD are all entirely different training paths.

If you want to run a lab doing diagnostic testing, the best thing you could do is talk to the person who runs your own workplace and ask them about what it takes (and what credentials you might need) to get into their position.

A PhD is expected to produce original research, which means coming up with a way to advance a particular field in conjunction with your PhD advisor. After you finish the PhD, which is typically 5-7 yrs in the life sciences, you typically have to complete at least one postdoc before you can apply competitively for jobs. A lot of jobs in industry allow you to do something to the effect of what you describe, but in the context of drug and/or technology development moreso than healthcare delivery.

an MD or DO will be 4 yrs of medical school where you will learn clinical medicine with the expectation of completing a residency and becoming board certified. It sounds like you would be interested in entering a field like Pathology or Radiology where you do not necessarily see patients directly but might run a service which provides diagnostic services to other physicians and healthcare providers. I don't know anything about DPM so I can't comment on that, although you should know that everything they do is related to podiatric health; i.e. feet.

From what you say, if further training in MLS or CLS is not ideal (for example, like an MS in CLS or diagnostics or something), it sounds like an MD/DO followed by a residency in Pathology would be closest to what you describe if you want to run the service. I'm not too familiar with PhD jobs in this area but there might be a way to do it as a PhD.

Journal of Vascular Surgery published a paper talked about the training and education of DPM and their role in limb salvage.

“The first 2 years include didactic basic science courses that closely mirror traditional allopathic and osteopathic medical education. In fact, the majority of schools of podiatric medicine are on joint campuses with allopathic or osteopathic medical schools with identical coursework.”

“The subsequent 2 years involve clinical instruction with clinical rotations in various specialties, including but not limited to internal medicine, infectious disease, orthopedics, general surgery, and vascular surgery in hospitals, outpatient clinics, and private practice settings.”

“After completing their medical education, students then matriculate into 3-year foot and ankle surgical residency programs. During this period of training the residents rotate through various surgical (general surgery, vascular surgery, orthopedic surgery, plastic surgery) and nonsurgical services (internal medicine, emergency medicine, infectious disease, radiology) with focused training in foot and ankle surgery.”

“Fellowship training is also available after completing a residency in areas such as research, sports medicine, foot and ankle reconstruction, trauma, and diabetic limb salvage.”

Source: https://www.jvascsurg.org/article/S0741-5214(12)01532-7/fulltext
 
So Im currently a CLS and have a year of experience. I want to open my own lab so I looked into the requirements and found a PhD can operate a high complexity lab just the same as an MD/DO/DPM, so Im going to pursue one of those degrees. My question is if my lab is going to be doing clinical diagnostic testing which of those professionals would providers be more inclined to send samples to? would they even care? could I do this kind of diagnostic testing with just a masters? Is routine lab work considered moderate or high complexity?


Interesting question. You're ambitious but this isn't practical.

Establishing a clinical lab requires tons of overhead, so making this a financially viable endeavor is challenging.

Also keep in mind that "providers" don't typically choose the lab - this is based on patient convenience, and insurance contracts.

Keep in mind that in the U.S., there are only a couple big companies that dominate clinical lab testing. Beyond those companies, plenty of hospitals/healthcare systems have their own in-house clinical labs.

All of the above means that your idea of "opening your own lab" isn't going to work.

If you want to direct a clinical lab, however, consider the MD degree followed by pathology residency.
 
great information ya'll, thanks! So there are some variables I didn't really think about. If we assumed I was able to take out a large enough loan to cover the costs of operating a small lab, and found a clinic in need of a moderate to high complexity lab, what would reimbursements look like per sample on avg and what would overhead look like assuming it was just me and one MLT to start? Is it completely unreasonable or could starting out small be feasible?
 
As an MLS and current laboratory manager, I will tell you that it is completely unreasonable to start a non-clinic attached lab. And at that, reimbursements are minuscule for most tests. I am the sole tech/manager etc. for a urology clinic. We run only PSAs and urine Micro. The net per sample is somewhere around $15 and it only works because a urology clinic pumps out a hundred of each of those a week. I wanted to bring other testimgbin house, but reimbursement is so small for all but the specialized/costly tests. CMP is about 55¢ per sample net, CBC is $1.25, UA is 15¢ etc etc.

Upfront costs for a lab will be immense. Between $20-45 thousand per instrument just For the smallest used instrument you can think of. You will need one for chem, heme, coag, immuno, UA and microscopy....Everything associated with micro (Fume hood, incubators etc.) You will need a $4-9 thousand annual service contract on each of those instruments, $2-10 thousand of consumables per instrument annually, you will need a facility which will cost who knows how much, you will need to purchase an EMR that links to the clinic you want to connect to along with the LIS (this will all be around $20-50 thousand plus annual fees depending on the EMR. You will also need proficiency testing ($200 per TEST per year)

Overall, you are looking at an up front cost of several hundred thousand dollars plus several tens of thousands annually in consumables and contracts. This is BEFORE staff. You will need no fewer than 3 techs to operate a full lab, preferably 5 or more so that there can be rotating schedules. You will also need 2 billing staff. Possibly a driver to collect samples, unless you want the techs to make that part of their job. Additionally, one person who is in charge of your QA program, community outreach, temp monitoring, supply ordering etc. Basically, you also have something like 6-10 full time staff to pay for. And you have NONE of the infrastructure or support that would be provided from being attached to a hospital, clinic or satalite facility.

There is a reason why Lab Corp and Quest are taking over everything from clinics, and even some hospitals. You NEED capital in the lab industry and you need massive volumes.

My lab at the clinic I work at only works because we only run 1 immono test and I convinced our board to purchase a fully automated micro system. Even then, we barely make anything on the micro, we only got it for reduced turn around time from our previous 5-7 days with send outs down to 2-4 days in house. That amount of supply is manageable for one person and the amount of billing was easy enough to Spears across the clinics current billing staff. And note, I didn’t start a lab by myself, they already had the instrument and wanted a tech part time (set my own schedule, perfect for being a college student). I did, however, jump through hoops to bring urine micro in house, however as stated it was not for the profits but after hearing one patient went septic after an 11 day turn around time without even reporting a gram stain that I just wanted our patients to have better care.

Overall, to answer your initial question, you would need a PhD in clinical laboratory sciences and past supervisory experience in each lab department you intend on pursuing. What I would do is instead get a masters in laboratory management to lead credence to and provide support for the bank to loan you hundreds of thousands of dollars and then find a pathology group who would be willing to supervise as laboratory director for a nominal fee.

However, as stated before, there is a reason that “start up laboratory” is not really a thing. The reference labs that are already in place WILL provide a better and cheaper solution and I would not recommend doing this plan.
 
PhD

Clinical diagnostics? Get an MS from a lab sciences program.

MS isn't sufficient for the clinical lab side.

Also, it's not quite right that you need a PhD in CLS, although that is an option. To effectively direct a lab (note I didn't say start one) you should essentially go one of three routes (i have seen non-doctoral trained people with the lab director title, some of that is institutional nomenclature, you can read the actual CLIA requirements here Certification Boards for Laboratory Directors of High Complexity Testing - Centers for Medicare & Medicaid Services )

1.) PhD in clinical lab science plus 2 year clinical lab fellowship like clinical chemistry, clinical microbiology, etc.

2.) PhD in a hard science like biochem or microbiology plus 2 year clinical lab fellowship

3.) Med school plus Pathology residency plus likely fellowship

Route 1 will likely give you the broadest base, but those degrees are newer and I'm not sure the extent to which the build the rigorous research type skills of a hard science PhD.

Route 2 is a bit less direct and might seem to be a waste of time getting the hard science research skills if you don't plan to do research, but it seems to help with troubleshooting and is pretty valuable if you're ever going to do diagnostics development

Route 3 is the most expensive route but it gives you the best clinical base. I've noticed a lot of pathologists don't seem real interested in the CP side of things. Some definitely are, but most seem to prefer AP.

All three training paths will incorporate lab management training.

So, back to the question about starting your own lab, as mentioned it's incredibly costly and difficult. It's going to be unrealistic for most people. Also, lab reimbursement is getting hit hard for everyone that isn't a large lab that can cut costs by having a massiv test volume.

The only time I've seen it is for small labs offering a unique service.

One example is my hometown which is in oil boom country. Lots of recreational drugs and therefore lots of employee drug testing. So this chemistry PhD decided to open up a mass spec drug testing lab. He gets lots of business, but has no formal clinical lab training and does some shady stuff according to the CLS folks that have worked there. It's not a good situation.

Another thing I've seen is an academic MD/researcher develop a diagnostic test for a biomarker and then develop that through clinical trials and then form a company to sell it or license it to an existing company.

But nothing is more dangerous than someone like the above chem dude with no clincal lab training trying to do diagnostics. There's sooo much that goes into it to work properly and not hurt patients.

For cautionary tale lookup Theranos and read the book "Bad Blood: Secrets and Lies in a Silicon Valley Startup"
 
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As an MLS and current laboratory manager, I will tell you that it is completely unreasonable to start a non-clinic attached lab. And at that, reimbursements are minuscule for most tests. I am the sole tech/manager etc. for a urology clinic. We run only PSAs and urine Micro. The net per sample is somewhere around $15 and it only works because a urology clinic pumps out a hundred of each of those a week. I wanted to bring other testimgbin house, but reimbursement is so small for all but the specialized/costly tests. CMP is about 55¢ per sample net, CBC is $1.25, UA is 15¢ etc etc.

Upfront costs for a lab will be immense. Between $20-45 thousand per instrument just For the smallest used instrument you can think of. You will need one for chem, heme, coag, immuno, UA and microscopy....Everything associated with micro (Fume hood, incubators etc.) You will need a $4-9 thousand annual service contract on each of those instruments, $2-10 thousand of consumables per instrument annually, you will need a facility which will cost who knows how much, you will need to purchase an EMR that links to the clinic you want to connect to along with the LIS (this will all be around $20-50 thousand plus annual fees depending on the EMR. You will also need proficiency testing ($200 per TEST per year)

Overall, you are looking at an up front cost of several hundred thousand dollars plus several tens of thousands annually in consumables and contracts. This is BEFORE staff. You will need no fewer than 3 techs to operate a full lab, preferably 5 or more so that there can be rotating schedules. You will also need 2 billing staff. Possibly a driver to collect samples, unless you want the techs to make that part of their job. Additionally, one person who is in charge of your QA program, community outreach, temp monitoring, supply ordering etc. Basically, you also have something like 6-10 full time staff to pay for. And you have NONE of the infrastructure or support that would be provided from being attached to a hospital, clinic or satalite facility.

There is a reason why Lab Corp and Quest are taking over everything from clinics, and even some hospitals. You NEED capital in the lab industry and you need massive volumes.

My lab at the clinic I work at only works because we only run 1 immono test and I convinced our board to purchase a fully automated micro system. Even then, we barely make anything on the micro, we only got it for reduced turn around time from our previous 5-7 days with send outs down to 2-4 days in house. That amount of supply is manageable for one person and the amount of billing was easy enough to Spears across the clinics current billing staff. And note, I didn’t start a lab by myself, they already had the instrument and wanted a tech part time (set my own schedule, perfect for being a college student). I did, however, jump through hoops to bring urine micro in house, however as stated it was not for the profits but after hearing one patient went septic after an 11 day turn around time without even reporting a gram stain that I just wanted our patients to have better care.

Overall, to answer your initial question, you would need a PhD in clinical laboratory sciences and past supervisory experience in each lab department you intend on pursuing. What I would do is instead get a masters in laboratory management to lead credence to and provide support for the bank to loan you hundreds of thousands of dollars and then find a pathology group who would be willing to supervise as laboratory director for a nominal fee.

However, as stated before, there is a reason that “start up laboratory” is not really a thing. The reference labs that are already in place WILL provide a better and cheaper solution and I would not recommend doing this plan.
I have an addendum to this: I have produced a proforma for Urine Micro. It is $127,000 upfront cost for everything (assume you already have a CLIA compliant building and a physician with micro experience to act as a lab director). Testing costs between $3-$11 per patient with reimbursement of $22-$46 per patient, all depending on the systems you use and methodology.

I am going with a fully automated system, so the net per positive culture with one organism will be $39 (an extra $21 per organism) and the net per negative culture is $26. Ignoring startup costs, in a year this will net the practice between $150,000 and $500,000 depending on our sample volume (25-100 samples per week). So, it can be profitable, it is just very difficult to get up and going.
 
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I believe it will depend on your state and I am sure it varies considerably from state to state. With that said, I have a former student who opened up a forensic toxicology lab 7 years ago. Started with 700 square feet and 3 guys. Today it does 20 million a year and has bought out by a venture capital firm. Just sayin!
 
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