How are new surgical procedures developed, tested, and implemented?

[1realway]

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Can anyone please explain in detail the process of how new surgical procedures get developed, tested, and implemented?
I have spent some time researching to figure out the answer, but I could not find any straightforward answer to this. (it might be because I just suck at googling)
I am a pre-med interested in the question above, and hope I found the appropriate sub-forum to ask this question. (If not, please redirect me)


The following is what I have gotten so far upon my searching:

1. Surgeons come up with some sort of creative surgical idea to fix a new problem (or problems with the current surgical procedures)
2. Test their ideas on animals (& and also get funding for this somehow)
3. Find human patients desperate enough for trials
4. As enough clinical results accumulates, gets FDA approval for the intended uses

Am I getting this right? Any missing holes in detail?


Remaining Questions:

• Is this whole process called "surgical research"? If not, what is the definition?
• What happens to the surgeon if his/her idea results in undesirable outcomes such as side effects or death? Are they somehow protected since it was a part of clinical trial?
• As a MD or DO, do you have to complete some sort of special residency in order to be able to develop new surgical procedures?
• As a MD/PhD, are there any additional trainings/residencies you have to complete?
• A scenario: A surgeon encounters an unexpected situation during a surgery in which he has to figure out a way to fix the problem. He instantly comes up with a radical and creative idea to fix it, which results in good outcomes. His work gets recognized, develops into an updated version of the particular surgery technique, and spawns other techniques inspired by it.
  • Is this possible? Can surgeons be creative like this one the spot or do they absolutely have to abide to their procedures?

Thank you so much for reading.
I would really appreciate it if you could help!

 

[VincentAdultman]

I don’t have a good answer, but copypasta-ing the same thing in multiple forums is bad form.

 

[mmmcdowe]

Moving to pre-allo.
The simple answer is you come up with an idea. You try it out on cadavers and, if feasible, perhaps some animals. Then you sign a patient up and do it and report it. Here's an example of a new approach via the eyebrow being reported for as far as I can tell the first time many years ago.

Thieme E-Journals - min - Minimally Invasive Neurosurgery / Abstract

Thieme E-Books & E-Journals

www.thieme-connect.com

It also ultimately depends on how far of a jump from past surgeries it is. Going from microscope to endoscope for example is a much smaller jump than the first time someone put a deep brain stimulator, but ultimately most of these things are baby steps forward. Before stimulation there was lesioning. Before pedicle screws there were Harrington rods. Eventually you get so far back in time that ethical considerations today such as IRBs and FDA review no longer have meaning.

Ultimately, anything that is experimental now adays requires patient consent for the experiment and so most complications or failures are covered under than that unless true negligence is found such as if you knew there was a change of it blowing up but didn't warn the patient or tell the other investigators. As far as minor variances in technique on the spot yes that also happens and yes it is reportable for publication, but these variations tend to be small such as figuring out a better way to stitch something not consenting the patient for one surgery and then coming up with something entirely different while they were asleep and doing it.

 

[LizzyM]

Surgeries that involve implantable devices are under the jurisdiction of the FDA and the protocol must be filed with the FDA, approved by an IRB, and conform with FDA regulations for research with human subjects. Typically, such a device would be tested in animals before clinical trials in humans are attempted. Typically, some of the expenses for the patients are covered by insurance and the device is provided free of charge by the manufacturer which is also the sponsor of the trial. Sometimes, a surgeon will collaborate with a manufacturer to modify an existing device. Sometimes a surgeon will have a financial interest in the new device which can present "conflict of interest" issues such that the "inventor" will not be allowed to be involved in recruiting and consenting patients to enter clinical trials.

Surgery that does not include a device or product (such as a filler or cement) is not under FDA jurisdiction but, if federally funded, it would be under similar regulations for human subjects research and require IRB approval and written informed consent of the subjects.

In either case, adverse outcomes must be reported to the IRB and, if under FDA oversight, reported to the FDA as well.

Tommy John Surgery (reconstruction of the ulnar collateral ligament of the elbow) was developed by Dr. Frank Jobe. You might find this interesting: Frank Jobe - Wikipedia

There is no special training or residency. Some docs will complete a masters degree in research or receive research coursework during a fellowship in a subspecialty that includes a research component.