Recently I was asked to present at the annual meeting of the MDMA –
The Medical Device Management Association. The program committee requested
that I speak about the most significant changes over the last five years
and what I am forecasting for the next five years. In addition, they indicated
the audience of device inventors, investors, and regulators from CMS and
the FDA, would be interested in exploring specifically how these changes
would affect the development of ned medical device technologies.
As always, I open my remarks by indicating that we are in the midst of
the most significant transformational changes in healthcare, a topic on
which Royer-Maddox-Herron Advisors have written numerous blogs and will
be the central theme in our book to be published shortly. The almost-radical
changes, including the movement to patient-centric ambulatory care, same-day
surgical procedures, and numerous virtual-medical monitoring devices,
nave been driven mainly by three things:
- Non-Invasive Medical Devices
- Safer and less toxic anesthesia agents
- Home infusion devices for antiobiotic and chemotherapies
Hence, It was appropriate for me to let those in the audience know, because
of their inventions and innovations , they are, first and foremost , the
HEROES and drivers of significant changes in healthcare, raising significantly
the quality and safety of medical outcomes.
However, I then also had to remind them quickly that medical errors, based
on a recent study at Johns Hopkins, have been found to be the third leading
cause of deaths in the United States, following heart disease and cancer,
which in fact are both declining. In addition, our group, and many others,
believe that 20% of medical care delivered today is unnecessary as a result
of an overuse or misuse of medical treatments and devices. In the United
States healthcare delivery has been driven by a competitive model so the
same medical devices have been duplicated in medical centers and doctors
offices located in close geographical areas. Because these devices must
generate a ROI – a return on the investment – they are often
used “because we have them”, rather than because the patient
will actually benefit from their utilization. In such scenarios, these
hero devices then become the
ENEMIES, contributing to the rise of medical cost, medical errors, and even fatal outcomes.
If new medical devices and innovative technologies are going to be embraced
by healthcare providers, they must embrace and support all componets of
the values equation:
Value = [Clinical Quality and Safety + Service Quality] / Cost
Each device will need to prove, with easily retrieved metrics, that its
use enhances: (1) quality and safety of the patient’s medical outcomes,
(2)improves patient satisfaction because of less pain, same-day surgical
potential, improved access, etc., and (3) reduces costs, including labor
and supplies. If this value is not better than the value of a similar
device already on the market, it is clear that payment reforms, being
implemented by both commercial and governmental payers, will not pay for
the new device. No longer will volume, often the driver of the misuse
and overuse previously mentioned, be rewarded financially. And we all
know, where the money flows so flows the technologies.
In addition to supporting the Value Equation, the most successful medical
devices of the future would also have the following attributes:
- Collect data on an ongoing basis
- Assist in the analysis of the data
- Early warning signals that the device is not working properly or wearing out
- Ability to connect to present information technologies, including electronic
medical records and iphones
- Support virtual medical technologies in both hospitals, ambulatory clinics,
and in the home
- Support the stabilization of chronic diseases, so these maladies become
a “way of life” rather than an illness
- Be feasible for a large group of people, assisting in population health
management and the movement to well-care versus sick-care, and,
- Utilize genomics, chips, 3-D printers, etc.
Because medical devices will continue to be the driver of all components
of the Value Equation, work must be done to overcome the challenges facing
the innovative and risk-taking inventors and investors today. These include:
- The regulatory barriers embedded in the CMS approval and reimbursement process
- Poor communications between CMS and FDA
- Short-life span of many devices
- Capital availability in health systems
- Capital availability from willing investors
- Significant barriers on getting patent approvals due to that fact that
many devices use information technologies pieces that are already patented,
raising the question of ownership
As in all transformation journeys, which often require significant changes,
there are challenges in developing enhanced technologies for the medical
industry, But these challenges must be addressed and overcome so the HEROES
will increase, and the ENEMIES will decline!