Medical device production is a critical sector of the economy. As such, producers must overcome these barriers to ensure that individuals obtain the tools they require without difficulty.
FREMONT, CA: Manufacturing medical devices can be a challenging process. There will always be a high demand for these technologies, which bodes well for future revenue, but numerous roadblocks exist in the way. Manufacturers must recognize and overcome these impediments for their benefit and the sake of public health.
The US medical device market is the world's largest, with analysts projecting that it will reach $208 billion by 2026. This presents manufacturers with a profitable opportunity, but attaining these gains is not always straightforward.
Here's a closer look at the industry's some difficulties and how to overcome them.
Regulatory Consequences: Navigating the industry's complex regulatory environment is one of the most ubiquitous issues in medical device manufacture. Manufacturers frequently experience inconsistency in regulatory wording and standards. It is not always evident whether or not anything must adhere to a particular set of criteria.
The most effective strategy for dealing with this inconsistency is to establish consistency on the side. Manufacturers should adhere to high-quality standards for all products, regardless of legal mandates. Industry-recognized standards, such as ISO 13495, which defines quality management systems for medical equipment, provide a sound foundation.
When regulatory divergences occur, it is often advisable to aim for the strictest to ensure compliance with the most significant number of standards possible. Additionally, it is prudent to establish a regulatory compliance committee intimately versed with applicable legislation professionals. They should vet any decisions before implementation.
Exorbitant Health Care Costs: High expenses are another significant issue in the healthcare industry. Approximately 46 million persons in the United States cannot afford proper treatment. While medical gadgets are not the sole cause of this problem, high device costs worsen it.
Medical device manufacturers are under growing pressure to reduce product costs, which can be difficult when high manufacturing costs. One option is to choose disposable products over more expensive, long-lasting alternatives. While this may seem contradictory, sterilization can cost up to $10 per device; thus, reusable items do not necessarily save money in the long run.
Additionally, 3D printing can help minimize manufacturing healthcare costs. Because this process adds material rather than removes it, it minimizes waste and lowers energy costs. As a result, total production expenses reduce.
Slow and Expensive Research and Development: Medical device manufacture requires extensive research and development more than any other sector. Conducting the appropriate clinical trials is frequently a lengthy and costly process that delays time to market and impairs profitability. Adopting technologies such as robotic process automation (RPA) and the cloud is one viable answer to this problem.
Cloud-based collaboration solutions enable the integration of heterogeneous clinical systems, combining data from numerous sources to get more comprehensive findings. These networks connect more than 20,000 hospitals, enabling producers to conduct extensive product testing across large sample sizes. Additionally, data from all sources can be updated in real-time by utilizing the cloud, accelerating the R&D process.
RPA can be used in conjunction with these cloud-based tools to expedite R&D even more. RPA automates typical data entry and organization processes, allowing staff to focus on higher-value tasks. Clinical trials will be shorter and more precise due to these technologies, lowering costs and accelerating return on investment.