How is it that some amazing medical innovations never make it and die in obscurity? Even if they work brilliantly, some innovations suffer an early death and are forgotten.
Boiling it down to a single word – adoption. In MedTech, adoption issues are critical to commercial success. There are multiple adoption factors and no single factor can assure success. This is true of drugs, devices or therapies. Established companies do a better job of focusing on adoption issues but they are not immune.
I spent 30 years developing great technologies dreamed up by other people. Such is the nature of contract product development. In our case, we specialized in medical devices, mostly ones that test blood and urine samples for patients. These devices would then fill up clinics, medical offices and labs where your samples go after you offer them up to a nurse or lab worker. The client would then make money manufacturing and selling the critical chemistries that are consumed by the machines for each patient sample.
One day a client approached us with a very sophisticated blood test they developed. This was an advanced version of a test commonly prescribed by cardiologists and other clinicians. Just about every patient in the country has had the common test at one time or another. However, it was thought, this new one would change the world.
Their new version of this test was more sensitive and far more detailed than the currently accepted test. They were certain that their new test was so powerful that it would easily take over from the well-worn test that everyone already knew. They planned on selling it to virtually every hospital and lab in the country before moving on to the rest of the world.
This client hired us to design and engineer a bench top machine that would run this new test in high volume. They would then have the machine manufactured in volume and sold everywhere. They would make a small fortune selling the special chemistries consumed by the machine for each patient sample. We spent over two years and at least $2 million of their money to create exactly what they wanted.
We never finished the project.
It seems that during these two years, the client was reaching out trying to drum up sales for a system that customers could not get excited about. I wanted to understand why.
One day I visited my own cardiologist, one of the top in his field, for my annual checkup. Afterward, I asked him if he knew about this new test.
He said “yes”
“Would you ever order it for your patients?” I asked.
“No”, he said dryly.
“Why not?”, I asked.
“Because it does not change the way I treat my patients”, he told me.
That was it. Game over. I knew this company was facing strong headwinds to commercialize their new test. The company eventually shut down.
I realized that doctors and other clinicians simply do not adopt new tests, methods or therapies simply because they are better. It takes a lot more than that. In healthcare, adoption takes a lot more than just being the newest or greatest.
I witnessed the same effect with another client that had invested tens of millions on an easier way to screen women for risk of breast cancer. Again, there were dreams of changing the world of breast cancer diagnostics. Women could be diagnosed years earlier, making preventative treatment easier. In spite of the evidence, low cost and ease of use, the clinical professionals simply did not adopt it. Again, the company shut down.
Adoption
Look at it from the clinical professionals point of view. Under what circumstances will they want to adopt a new device, drug, test or procedure? What are the risks and rewards? Would you want to be treated by a doctor that wants to try out anything new that comes along?
Many people already understand that new healthcare innovations must be tested first in the lab and later on animals and people. It takes far more than that, however. Here are some key points:
FDA Approval – Although the FDA does not specifically endorse a drug or device, they do evaluate and approve them based on the claims of the manufacturer and documented clinical trial results. They evaluate safety and efficacy and approve the Indications for Use. In general, you cannot legally sell a drug or device to a patient or healthcare provider without FDA approval (there are exceptions but that is a separate article).
Clinician Adoption – Key Opinion Leaders (KOL’s) in the field must endorse the technology. They must be Independant professionals who are respected in their fields. They get first hand experience with it and then publish objective results in professional journals. They also present their findings at professional conferences and give presentations to other professionals. Clinician familiarity with the technology is also critical. Drug and device companies have critical programs in place to provide detailed support information and training on the use, risks and outcomes of the technology. Clinicians also depend on positive patient awareness (see below).
Professional Adoption – Many times the gold standard in adoption are recommendations from professional organizations such as the American Medical Association (AMA), American Hospital Association (AHA), etc. This can be a long road to achieve but the rewards are huge.
Institutional Adoption – Once you have clinician adoption, the institutional providers (hospitals, clinics, etc.) must get a favorable view of the technology. Sometimes a key institution (such as a university clinic or hospital) must embrace the technology, at least for a trial period. Successful results must be evaluated and published. Providers look at a different set of criteria to evaluate success. This includes cost, risk, reimbursement, recidivism, reputation and more. They want to understand the total impact of adoption.
Third Part Payer Adoption – Insurance companies and government programs such as Medicare must approve and adopt the technology or there may be no reimbursement. Typically, they look at efficacy and long-term cost savings. They are less likely to approve and pay for controversial treatments.
Patient Awareness – Patients rely heavily on the recommendations of clinicians and institutions they trust. They can be strongly influenced by media promotions such as magazine ads and TV commercials. This is why you see massive amounts of money spent advertising products that you cannot buy yourself but must be prescribed by a doctor.
What has been your experience? Write me with your own stories.
RWH
Medical Technology Insights 