What makes top medical device companies successful? The first answer for most would likely be profit, but profit is a product of success, not the key to success. Given the complexity of developing medical devices, the challenges companies face from concept to production to regulatory approval to market are many. Today’s healthcare industry is fluid. Medical device companies cannot simply offer a unique product or technical expertise to ensure sales. It needs to consolidate such offerings into healthcare systems to provide a broad range of solutions that are need-based for all parties—patients, physicians, clinicians, insurers, and other companies. (more…)
Statistical process control (SPC) has proven to be an effective means for original equipment manufacturers (OEM) of medical devices to maintain and even improve product quality. SPC utilizes statistical methods, quantitative and graphic analysis of measurements, to evaluate and assess the stability of a process and the resulting quality of its production. Manufacturers that implement the process can reduce time to market, increase production, and take the guesswork out of quality control. (more…)
Sample preparation in medical device design and testing serves as an investigative procedure to assess qualitative and quantitative measures and performances. Safety and quality are the preeminent factors in the medical device manufacturing industry. Stringent regulatory requirements are in place for every phase of a device’s life cycle, including design and testing. OEMs (Original Equipment Manufacturer) and companies that can design and then test medical devices or parts serve a vital role in the medical device industry. However, it’s imperative when looking for companies that can design and then test medical devices or parts demonstrate their quality management processes and practice in all facets of the product lifecycle. (more…)
When companies, developers, and inventors seek contract manufacturing services for their medical devices, selecting the right medical service OEM (Original Equipment Manufacturer) is vital for the overall success of their new product. With all the levels of complexities, shapes, sizes, demands, and varying technologies for medical devices on today’s market, the medical device contract manufacturing services company is in a prime position to fill an ever-expanding niche in the medical device manufacturing sector. The strict regulatory environment combined with rigorous international standards, place a high demand for companies that can provide regulatory expertise and fulfill a project from product design and development to testing, validation and verification, manufacturing, and delivery to the marketplace. (more…)
There’s little doubt that the medical device manufacturing industry is expanding worldwide and medical contract manufacturing services a large part of it. Over the past several decades, the industry, and the contract manufacturing sector has met the challenges of ever-increasing demand and reshaped medical technology. There are near 5,800 companies employing over 350,000 people in the industry. Last year, the United States alone accounted for nearly half –45 percent of sales—of the $413 billion global market for medical devices. With the industry growth rate at 5 percent annually, projected sales by 2022 will be approaching $530 billion. As the global market for medical device manufacturers increases, so will the need for more companies and people in the industry. Expect the role of contract manufacturing to play an even greater part in the years ahead. (more…)
For over 30 years, BMP Medical has produced components for in vitro diagnostic medical devices testing. In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, detect, treat, or prevent disease, or a disease that is a consequence of a previous health condition, i.e., its sequelae. (more…)
Original Equipment Manufacturers (OEM) of medical devices must perform and pass FDA approved medical device process validation and verification before any product can be introduced on the market. In the medical device industry, process validation and verification is a term that indicates that a product, service or other outcome has been subjected to such scrutiny that the result of the process can be practically guaranteed. This is significantly important not only to satisfy FDA requirements for public health and safety but to ensure business success. Processing deficiencies may only be revealed through process validation and verification. 
Validation of a process involves demonstrating that a product will consistently produce and comply with predetermined requirements as defined in its design and development. It is defined by the FDA as “confirmation of a product by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Process validation is designed to establish by “objective evidence that a process consistently produces a result or product meeting its predetermined specifications.” FDA regulations state that verification is defined as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” These are necessary steps to ensure that all medical devices meet regulatory standards for the health and well-being of the public. No doubt that the wide range of challenges that OEM’s of medical devices encounter in manufacturing specific products is immense. Medical devices are manufactured by OEM’s whose size, structure, management methods, production capacity, and assembly lines can vary substantially. Production and assembly, i.e., the number of manufacturing steps per unit (e.g. adhesives or soldering steps) will considerably influence how process validation and verification will be applied.
Technologies and applications must vary to meet the challenges above. Medical devices range from small hand tools to complex computer-controlled surgical equipment; from implantable pins, rods, screws, and plates to artificial limbs and organs. Something as minor as blood-glucose testing strips to major diagnostic imaging systems such as X-ray and ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear or positron emission tomography (PET)—even laboratory test equipment—must go through the regulatory process. The completion of process validation is a regulatory requirement that a manufacturer must adhere to. It is best to start the validation and verification process as early as possible and choose the right validation expert to guide your product through the required steps. Properly controlled design and development activities can reduce the length of time to market for new products.
In general, to meet compliance and award approval, manufacturers should follow three protocols with the overall objective to formulate a plan to: obtain data, record data, and interpret data. The process begins with the installation qualification (IQ) protocol. Whereby, an initial qualification of the equipment used and provision of necessary services are met. The second step is the operational qualification (OQ) protocol to demonstrate that the process will produce acceptable results, test limits and establish process parameters. The third phase is the performance qualification (PQ) protocol. This step should be designed to establish long-term process stability. In sum, OEM’s are legally obligated to meet the requirements for process validation and verification as established by FDA regulations. Understanding how to perform process validation is therefore vital to a company’s success. Compliance in performing process validation will help ensure a predictable and predetermined outcome, reduce the time it takes to get a medical device to the market, help reduce costs, and successfully complete process validation and verification of your product to receive FDA approval.
All medical devices sold in the United States are regulated by the U.S. Food and Drug Administration (FDA). More specifically, any medical device manufactured, repackaged, relabeled, and/or imported by any company or firm to sell in the U.S. has to meet FDA regulations. (more…)
Medical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in judgments and settlements collected in the fiscal year 2016. (more…)
One of the most important phases of a medical product development life cycle is the relationship between your company’s validation expert and the original equipment manufacturer (OEM) of your medical product.
It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the timing of delivery to market, keeping costs within budgeted estimates, and the success of your product. (more…)
