This just in: You aren’t getting any younger and neither is anyone else. What this means for the health care industry is, well, complicated.
As the U.S. population continues to age, hospitals will see an increasing volume of vascular procedures. At the same time, the U.S. Food and Drug Administration (FDA) is looking to revise its medical device approval process. The changes could mean a quicker availability of new medical devices with improved performance data upon market introduction. The future growth in procedures and the increasing reimbursement trend for these categories mean hospitals should be able to incorporate these new technologies to enhance patient care.
Here are three insights from our recent Vizient Technology Watch, focused on vascular technologies.
Changes in the medical device approval process may improve new device performance information at time of market introduction.
In the early 1990s, the FDA implemented new regulations on the clearances and approvals of medical devices, which slowed the flow of new devices. At the same time, the formation of the European Union created a movement of medical device development outside the U.S. Since that time, medical devices have been approved for use in Europe sooner than in this country. Companies have been able to generate sales while waiting for their U.S. 510(k) clearances or pre-market approvals from the FDA. In some cases, early-device limitations were uncovered and corrected before the device was sold in the U.S.
This scenario is now changing. New European Union regulations passed in 2017 – and taking effect in 2020 – will require medical device manufacturers to provide additional information on the safety and efficacy of the devices prior to being approved. The hope is this increase in data will help hospitals, physicians and clinical staff make better choices for their patients. It may also mean a shorter gap between when medical devices are available for use outside the U.S. versus inside the U.S.
Peripheral vascular device market continues its steady growth, while coronary device market inches along.
Approximately 8 million Americans are affected by peripheral artery disease, which is characterized by cramping, pain or tiredness in the leg or hip muscles while walking or climbing stairs. Its prevalence doubles to 10% in our 70s and doubles again to 20% in our 80s.
The treatment of vascular artery blood flow is the largest segment in the peripheral vascular device market. For each procedure, a variety of unique medical devices may be used. As complexity increases, similar procedures might be performed in different locations within a hospital by different physician specialists. For example, vascular stenting can be performed in the interventional radiology labs, catheterization labs or the hybrid operating rooms.
A market analysis by Medtech 360 estimates a 3% to 4% sustained procedural growth rate through 2025 in the angioplasty, stent and atherectomy segments. While procedural rates continue growing, pricing pressure continues to drive stent and balloon unit prices lower at a rate of 5% to 7% annually. Despite the declining prices, new competitors are in clinical trials to gain FDA approval or clearance to sell their peripheral vascular devices in the U.S.
The coronary device market is forecast to increase slowly. Procedures are projected to grow at a sustained rate of less than 1% through 2027, increasing from 2.5 million to 2.8 million procedures, according to a Medtech 360 estimate.
One device – the coronary bioresorbable-coated drug-eluting stent – has become the most prevalent stent outside the U.S. within percutaneous coronary intervention procedures. New suppliers to this market have made investments in the U.S. market and are conducting clinical trials to gain FDA approvals and clearances.
Increasing numbers of trained physicians and improving technologies are rapidly evolving the neurovascular market.
Stroke is the fifth-leading killer of American adults, affecting 800,000 Americans each year and killing nearly 130,000. According to a Medtech 360 report, the 2018 U.S. neurovascular market value is estimated at $735 million, with procedural growth forecast to increase at a healthy 2.25% rate through 2026. Great strides have been made in the treatment of both types of stroke and medical devices are improving to treat a wider array of conditions.
This once-niche market, which was centered only in academic medical centers and the largest medical centers by a small group of neurointerventional radiologists, has expanded into mid-sized medical centers now including neurointerventionalists and neurosurgeons. As the orthopedic suppliers have acquired these neurovascular device companies, pricing strategies have emerged, focused on premium pricing and annual increases. Strong physician preference and supplier relationships make pricing control challenging. Supply chain executives must focus on the rapidly growing neurovascular market and develop strategies with their physicians to manage procedural cost and growth.
You can read the details of our study here, including lists of FDA-approved coronary, peripheral vascular and neurovascular devices as well what’s in development, but don’t wait too long. Remember – you’re not getting any younger.
About the author. As director of strategic initiatives and new technology for physician preference sourcing operations, Craig Lukowski leads the team's strategic support, innovative program development, new technology assessment and education initiatives. His extensive experience working with both domestic and international medical device suppliers, health care providers and markets gives him the insight to assist hospitals in developing strategies for cost reduction through supplier negotiations, physician relationship development and practice change management.