Medical device sales and services is a large, global, and competitive annual $billion industry. It is divided into different categories like Cardiology, Oncology, Neuro, Orthopedic, Aesthetic and Healthcare devices. This industry continues to grow at an astounding rate each year due to people living longer and the increase in demand for different types of innovative medical devices.
In spite of its growing capacity, several growth constraints exist in the industry. One of its constraints involved in the industry is the Eco-system Regulations. Medical equipment companies are affected by the reimbursement risk from CMS (Center for Medicare and Medicaid) and private insurance companies for their products. Currently, reimbursement for devices is administered by third party agencies that constantly develop different ways to control healthcare costs and cuts for reimbursement to lower the amount for medical expenses.
Healthcare reform in America was introduced in 2010, called the 'Patient Protexion & Affordable Care Act'. This new bill gave rise to a degree of unpredictability for the medial device industry. The bill led to the pricing of some devices being controlled, which could eventually pressure companies to decrease prices for medical devices across the board, and could place more taxes on device companies.
The 510 (k) reform declared by FDA is another constraint device companies should be concerned about. Under this reformed bill, FDA extended the user fees on medical device and prescription companies through fiscal year 2012. Section 221 of the law gives FDA the authority to 'conduct third-party reviews' on 510 submissions throughout 2012 to assure that all devices are safe and effective for public use.
In addition to the 510 (k) reform, FDA's Centre for Disease & Radiological Health (CDRH) office established a new Centre Science Council (CSC) to incorporate innovative science and technology methods for the clearance or acceptance of new submissions. The CSC is comprised of senior managers associated with FDA and its affiliates.
In conclusion, CDRH produced a 10 year forecast in 2008 to recognise and oversee new medical device technologies and products coming on the market. The purpose of the forecast was to prepare CDRH for innovative products that may be scientific or regulatory questionable, and to identify the scientific issues and regulatory strategies for these new products over the next decade. For additional information on growth constraints in the medical device industry please contact the Centre for Devices & Radiological Health - White Oak Campus in Silvre Spring, MD.