Health care delivery in the United States is currently undergoing substantial changes to address issues of cost, quality, and access. I developed the first version of this slide in 2012 and have been updating it as new trends are identified. I’m curious to see how many of the “Future State” items will become “Current State” over the next 5 years.
For anyone that follows the trajectory of proposed health care changes in the United States, you’ve probably noticed that authors and speakers have a tendency to use a variety of verbs to convey the urgency of realizing it. Some of the verbs I’ve seen attached to health care include “transform, “disrupt,” and “reinvent.”
Now I understand – and agree with – many of the calls to bring about change in the U.S. health care system. But, I can’t help wondering if too much time is spent attempting to identify new verbs to explain it at the expense of digging in and making it happen.
Those of us with a strong interest in seeing change come to fruition have been afforded an amazing opportunity to undertake this noble challenge of addressing this fundamental issue: fixing health care over the next twenty years.
We did not arrive at this place overnight, nor will we solve the numerous challenges without thoughtful effort. But, if committed people are unwilling to step up and lead, then we will remain in this morass that is slowly drowning us all.
So, let us focus less on identifying verbs to explain the change and work toward bringing it about with all expediency.
“…the potential sources of danger that we believe warrant the greatest attention for the coming year. The list does not enumerate the most frequently reported problems or the ones associated with the most severe consequences—although we do consider such information in our analysis. Rather, the list reflects our judgment about which risks should receive priority now.” (p. 2)
The list includes:
- Ransomware and Other Cybersecurity Threats to Healthcare Delivery Can Endanger Patients
- Endoscope Reprocessing Failures Continue to Expose Patients to Infection Risk
- Mattresses and Covers May Be Infected by Body Fluids and Microbiological Contaminants
- Missed Alarms May Result from Inappropriately Configured Secondary Notification Devices and Systems
- Improper Cleaning May Cause Device Malfunctions, Equipment Failures, and Potential for Patient Injury
- Unholstered Electrosurgical Active Electrodes Can Lead to Patient Burns
- Inadequate Use of Digital Imaging Tools May Lead to Unnecessary Radiation Exposure
- Workarounds Can Negate the Safety Advantages of Bar-Coded Medication Administration Systems
- Flaws in Medical Device Networking Can Lead to Delayed or Inappropriate Care
- Slow Adoption of Safer Enteral Feeding Connectors Leaves Patients at Risk
If you’re interested in getting your own copy of the Executive Brief, visit this link.
“The annual Top 10 Medical Innovations was developed to share what our clinical leaders are saying to each other and what innovations they feel will help shape healthcare over the next 12 months and beyond.”
They have multiple criteria that medical innovations have to meet before they are considered, including: (a) significant clinical impact; (b) significant patient benefit; (c) high user-related functionality that improves healthcare delivery; (d) high probability of commercial success; (e) available on the market in the next year; (f) must have significant human interest in its application or benefits; and (g) must have the ability to visualize human impact.
This year the Top 10 list includes:
- Hybrid Closed-Loop Insulin Delivery System
- Neuromodulation to Treat Obstructive Sleep Apnea
- Gene Therapy for Inherited Retinal Diseases
- The Unprecedented Reduction of LDL Cholesterol
- The Emergence of Distance Health
- Next Generation Vaccine Platforms
- Arsenal of Targeted Breast Cancer Therapies
- Enhance Recovery After Surgery
- Centralized Monitoring of Hospital Patients
- Scalp Cooling for Reducing Chemotherapy Induced Hair Loss
On September 6th, the FDA issued the guidance document Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.
According to the document:
“This guidance is intended to highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices: 1) designing systems with interoperability as an objective; 2) conducting appropriate verification, validation and risk management activities; and 3) specifying the relevant functional, performance, and interface characteristics in a user-available manner such as labeling.” (p. 3)
For those new to the topic, they define interoperability “…as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” (p. 2)
With respect to human factors, it highlights a couple areas of importance for our discipline, including:
- “Validate the user(s) interface. Determine that the user(s) are capable of correctly using the interface(s)” (p. 11)
- “Validation of labeling regarding the use of the electronic interface should consider human factors as appropriate.” (p. 17)
It’s good to see that the FDA understands the challenges associated with interoperability and that human factors is an important part of designing, developing, and deploying interoperable technology that allows users to safely and effectively perform their duties.
“Numerous other problems help account for why there has been so little positive change in workplaces or careers. Here’s one of the more important: There are no “barriers to entry” into the leadership industry; no credentials, rigorous research, knowledge of the relevant scientific evidence, or anything else required to pass oneself off as a leadership expert. Anyone and everyone can write a book, be a leadership speaker or a blogger, offer consulting and advice, or start a leadership-development or consulting firm.” (p. 24)
Pfeffer, J. (2015). Leadership BS: Fixing Workplaces and Careers One Truth at a Time. New York: Harper Business.
For readers in the United States, I hope that you’ve had a great Labor Day weekend! We’ve just returned from a nice getaway to one of my favorite places – Ketchum, Idaho. I had the opportunity to hike to Pioneer Cabin (photo above), mountain bike Bald Mountain (photo below), and spend quality time with family.
I also spent time contemplating the future of healthcare – something I’ll be writing about more over the coming months.
Until then, let me stress the importance of taking time off from work to recharge your batteries and stay in touch with what’s most important with each of your lives. Work is great – especially if you love what you do – but it shouldn’t be your only reason for rising each morning.
When most people think of Idaho, it typically conjures images of rugged mountains, fast running rivers, or maybe even potatoes. But what about medical innovation? Probably not.
While historically not a hotbed for medical innovation, Idaho has been making strides over the last several years. Below are some of the medical innovation companies that are making a difference around the world.
NOTE: This post will be updated as more medical innovation companies are identified. If you know of Idaho-based medical innovation companies that should be added to this list, please contact me.