A pill with an ingestible digital sensor to track medication adherence. Medication implants and injectable medications for opioid addiction. New formulations for long-acting injectable medications for schizophrenia. These are just a few of the recent approvals by the Food and Drug Administration (FDA) of new digital treatment technologies (see The Emerging Digital Treatment Era) and innovative medication formulations in the complex consumer space (see Predicting The Future Of Medications-More Options & More Medication Adherence). This is a whole new wave of treatment options available to consumers.
For executives of provider organizations and health plans, this continual stream of treatment innovations brings a new challenge—how to evaluate new treatment options and decide which to endorse on a timely basis. Historically, there has been a much discussed (but never changed) “science to service” lag of 17 years in health care, meaning that on average, it takes almost two decades for innovations in health care to become mainstream best practices (see The answer is 17 years, what is the question: understanding time lags in translational research).
But that historical lag isn’t going to work going forward. The advantage will go to the organizations that can adopt “consumer desired” treatment options quickly—and to organizations that adopt new developments that decrease the costs of care. Speed matters in an increasingly competitive market.
If your organization is not as “nimble” as you would like, get ready. The FDA is planning to make the approval process for these new developments faster with their new Breakthrough Devices Program. Under the new program, for certain medical devices that provide for more effective treatment or diagnosis, the FDA will speed the approval process (see Breakthrough Devices Program: Draft Guidance For Industry & Food & Drug Administration Staff). The program was originally added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act in 2016; in 2017 the FDA published the plan for the program (see Federal Register 49374: Food & Drug Administration Breakthrough Devices Program; Draft Guidance).
We’re seeing some of the first pending treatments in the new expedited program. In June, Sage Therapeutics announced an expedited development plan for SAGE-217, a treatment for major depressive disorder (MDD) and postpartum depression (PPD) (see FDA Provides Expedited Path Forward For Sage Therapeutics SAGE-217 As Treatment For Major Depressive Disorder). In July, the Roche’s Elecsys cerebrospinal fluid (CSF) tests for Alzheimer’s disease biomarkers was added to the Breakthrough Devices Program; the Elecsys CSF immunoassays measure biomarkers of Alzheimer’s disease in adults with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia (see Roche Biomarker Tests For Alzheimer’s Disease Gains FDA Breakthrough Designation).
Tracking the flow of new innovations that have either gained acceptance, or will soon, should be added to the strategic market intelligence needed by executives in the health and human services field. Keeping up with the best tools to improve the service “value equation” is essential.
For more of our coverage on medical devices and new science, check out these resources from the OPEN MINDS Industry Library:
- FDA Approved Monthly Subcutaneous Medicine For Schizophrenia
- Alkermes’ Aristada Initio Approved By FDA For Schizophrenia
- FDA Approves First Generic Versions Of Suboxone Sublingual Film
- University Of Iowa Health Care First To Adopt Landmark FDA Approved AI Device In Diabetes Setting
- FDA Approves First Drug Comprised Of An Active Ingredient Derived From Marijuana To Treat Rare, Severe Forms Of Epilepsy
- FDA Approves Lucemyra Non-Opioid Drug To Ease Withdrawal Symptoms
- Looking Ahead At Diagnostic Tools For Autism
- Fitbit Announces New Partnerships To Focus On Chronic Disease Management
- One-Day Injectable Aripiprazole Tx Passes Test
- Janssen Closes In On Seeking FDA Approval For Ketamine-Based Depression Treatment
- Otsuka Receives FDA Go-Ahead For Kidney Disease Drug
- Magellan Launches New Digital App For Chronic Pain Management
- Medical Device Industry Makes Moves To Value-Based Care
- Value Comes To Pharmaceuticals, Devices & Digital Treatment
- TMS 10 Years Later
Looking for more on the developing tech in the health and human service field? Join me on October 23-24 in Philadelphia for The 2018 OPEN MINDS Technology & Informatics Institute, including the session “How To Make The Right Tech Investments For Your Organization: An OPEN MINDS Executive Seminar On Technology Budgeting & Planning”, by OPEN MINDS Senior Associate Ken Carr; and the session “Small Scale Technology Planning & Budgeting: A Roundtable Discussion For Organizations Under $25M”, with OPEN MINDS Senior Associate Sharon Hicks.