In addition to complying with rules over worker safety, medical device manufacturers must also account for federal regulations for these parts. The U.S. Food and Drug Administration’s Center for Devices and Radiological Health oversees device regulations with medical devices put into several categories, including Class I, II and III. Medical device component parts that fall under federal regulation include any raw material, substance, piece, part, software, firmware, labeling or assembly that is intended for a finished device, according to FDA. Plant managers and engineers should choose parts that will allow them to comply with federal law and provide high quality products for their customers.
Compliance with Federal Regulations
Whether developing new parts or replacing their older models, manufacturers are aware of the rising cost of medical device manufacturing due to the scarcity of skilled labor, increase in device regulations and need for quality health care parts and technology demanded by a greater aging population. To maintain reasonable product costs, medical device companies will take into account the overall expenses with manufacturing, testing, packaging and shipping products. These parts will also have to meet business goals like overall equipment effectiveness and lower productivity losses that are crucial for companies’ bottom lines.
Cost of production
The customer base of numerous medical devices is steadily growing older, leading to manufacturers reconsidering how their devices will perform for patients who have a greater lifespan and need long term or chronic care. One of the trends driving the growth of the medical device market is the increase in individuals age 65 years and older that will require devices like pacemakers and machines like insulin pumps.
The Population Reference Bureau found the average life expectancy in the U.S. rose to 79 years compared to 68 years six decades ago and the number of adults in the U.S. 65 and older is expected to double to more than 98 million by 2060. This aging population presents new challenges for medical device manufacturers to choose parts that are long-lasting and provide the quality care demanded by their customer base.
Quality and Performance
Will the environment for these medical device component parts be damp, sterile, etc.? Knowing the answers to these questions ahead of time is vital to choosing the right parts for the proper scenario, whether these parts will ultimately be used for devices in emergency rooms or home care. Select equipment and parts that will withstand harsh environments, from corrosion to exposure to harmful chemicals, and continue to function as intended.
With these various requirements for medical device parts, manufacturers will have to contemplate how they will stay competitive in the marketplace and keep up with trends in patient care. Through expanding automation and utilizing more efficient machinery, medical device manufacturers will be able to comply with regulations, keep manufacturing costs down and produce at a pace that meets consumer demand.
Experienced professional with 30+ years working in creative technical fields. From my post-college years installing windmills in the mid-west (I affectionately call my Don Quixote years) through starting on the drafting boards at a Fortune 1,000 company, I have strived to provide unique out-of-the-box designs. This aptitude, coupled with leadership opportunities has led me down a wonderful path of challenging work.