Recent news that the US Food and Drug Administration (FDA) will use ISO 13485 as the basis for its quality system legislation for medical devices was well received by those in the industry, perhaps none more than the ISO (International Organization for Standardization) itself. ISO 13485 is the international standard for quality management systems (QMS) that establish requirements for regulatory purposes for the medical device sector. The regulation is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. The move by the FDA is intended to help streamline regulatory processes for medical devices around the world.

The FDA’s decision to use ISO 13485 will also help the standard gain further recognition. By replacing the current quality system regulation, the FDA is taking an important step in the recognition that ISO 13485 has already gained globally. The convergence of medical device regulatory processes has been a goal of ISO for decades. The standard is already the foundation for the Medical Devices Single Audit Program (MDSAP) that is currently used by Australia, Brazil, Canada, Japan, and the USA.

As the impact of the FDA adopting ISO 13485 to replace its current regulatory system for quality management has begun to sink in, questions concerning QMS by medical device manufacturers, companies, and organizations have been steadily growing. Below is an FAQ primer in anticipation of the changes:

Why should medical device companies have a quality management system (QMS)?

The practice of implementing a QMS is a long-term strategic decision that, once in place, works to guide your company or organization to consistently meet standards, improve overall performance, and to provide a sound basis for sustainable development initiatives. A QMS also gives assurances and confidence to customers that the most stringent requirements for quality have been met.

What is an ISO 13485 Quality Management System?

Implementing a QMS for ISO 13485 follows a set of conformance requirements and interrelated processes, including any guidelines that establish, implement, and maintain the provisions outlined in the requirements of the standard with the aim of meeting customer and applicable regulatory requirements for businesses operating in the medical device sector.

What are the requirements for ISO 13485 compliance?

For medical device companies to be ISO 13485 compliant, they must have a QMS that demonstrates an ability to provide medical devices and related services that meet applicable regulatory requirements and customer approval. This standard applies to any company or organization that is involved with any one or more stages of the life-cycle of a medical device. This can include design and development, production, manufacturing, packaging, storage and distribution, installation, or servicing of a medical device or provision of associated activities such as technical support, supply chains, or product related consulting services.

Are there testing requirements for ISO 13485?

There are no testing requirements, but there are standards that must be met. Because ISO 13485 is considered a stand-alone set of quality management requirements, manufacturers of medical devices and related support and service organizations must provide documented evidence that their devices will meet safety and quality standards and perform as intended for patients or consumers. Testing of a particular product is part of the overall QMS which companies implement to meet the numerous requirements of various regulations and standards.

Does Biomedical Polymers, Inc., adhere to ISO 13485?

BMP is a global manufacturer of plastic medical devices that are used in research and medical diagnostic laboratories. As an Original Equipment Manufacturer (OEM) of medical devices, adherence to ISO 13485 has been critical to its success. BMP implemented a QMS that met the requirements of certification for ISO 13485 in 2016. Today, it provides design and engineering consultation, coordinates tooling fabrication and mold parts to specification and meets production with a state-of-the-art plastic injection molding and injection blow molding equipment all under the auspices of ISO 13485.

The demand for research and medical diagnostic products grows annually. Because medical diagnostic devices are used in the testing, treatment, prevention, monitoring, studying, and diagnosis of diseases and other biological human conditions, companies that develop and manufacture such diagnostic products are well positioned to serve an important and vital role in health and healthcare, the biological sciences, and all medical-related disciplines and industries. Combined with the ever-expanding field of material sciences in plastics, along with technological innovation and advancement moving ahead at a rapid pace, engineers and device manufacturers are making great strides in the development of diagnostic products.

Innovation in Medical Diagnostic Device Development

Nevertheless, great care must be made when a diagnostic device is brought to market. It is an end result of a lengthy, multi-step process that includes material, time and financial investment—not only in research and development, design, and manufacturing, but the entire process of verification and validation, regulatory approval, and market placement that comprises each stage of the product life-cycle. From conception to finished commercial product, medical devices requires innovative engineers and product designers, experienced project managers, quality control experts, and substantial regulatory expertise to make that transition a successful one. A successful and quite common practice for companies, inventors and entrepreneurs to bring their device to market is through contracting Original Equipment Manufacturers (OEM) of medical devices. Contract manufacturing of medical devices is the system by which a manufacturing company makes medical devices or components of medical devices that are later sold by another company. Effective manufacturing systems can also offer areas of expertise in engineering, design, molding, assembly, and R&D, and range in capabilities from prototype to long production runs. Particularly with the medical device market, OEMs must provide specialized facilities for manufacturing such products, and have on-site medical labs for all stages of production, from concept to design to manufacturing. Labs give engineers the opportunity to validate and verify new products, plus allow for modification or change in design as needed.

How Can an OEM Contract Manufacturer Benefit Your Company?

As an OEM contract manufacturer, Biomedical Polymers, Inc., provides all such services for the medical device industry. The company stands at the forefront in meeting the demand of research and medical diagnostic products and is part of a greater medical plastic engineering community that serves the research, biomedical, and medical diagnostic laboratory markets that manufactures a variety of diagnostic products for research and medical laboratories worldwide. BMP, not only contract manufactures private labeled products for distribution but has its own line of products, too. As an OEM of plastic consumables and plastic products for research and medical diagnostic laboratories, BMP products are produced to the highest quality standards. Our engineers offer over three decades of expertise with a focus on new trends and technologies in the field of plastic materials including polycarbonate, polypropylene, polyethylene, and thermoplastics, or custom formulate polymers to meet specific application needs. State-of-the-art plastic injection molding capabilities provide sterile, high-quality medical devices that serve clinical laboratories and research labs. Design consultation, engineering, drawing, R&D, tooling, mold development, computer automation, and statistical process control for mid-tier products are all onsite. The BMP facility is also equipped with a Class 8 clean room for manufacturing, packaging, and assembly needs and meets all regulatory requirements for medical device engineering. As the development of research and medical diagnostic products continues to expand worldwide, you’ll find in Biomedical Polymers a global manufacturer that specializes in the custom manufacture of both disposable and reusable small-to-medium plastic parts for research, biomedical, and medical diagnostic laboratories everywhere.

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.

Statistical process control is nothing new to manufacturers or industry. In 1924, a statistician at Bell Laboratories, William A. Shewart, developed the control chart and the concept that a process could be in statistical control. SPC proved to be a better and more efficient way to monitor product quality without compromising safety. Today, advanced SPC software is widely used as a quality tool throughout many industries. SPC is an effective way to drive continuous improvement. By monitoring and controlling a process, we can assure that it operates at its fullest potential. As a method to measure and effectively control the quality of the manufacturing process, it’s considered by many as second to none. Quality data is collected in the form of product or process measurements or readings from various machines or instrumentation. The data is collected and used to evaluate, monitor and control a process. SPC is ideal in mass production of medical devices for the program allows continual output through the use of control charts rather than inspecting each individual lot of a device. FDA also allows product release using SPC as long as the process is well-documented and thoroughly reviewed. This eliminates interruptions in production, and also facilitates the detection of trends and defects earlier on, which further reduces rework, retooling, and material waste. SPC methods are also predictive tools that should be a part of a manufacturers' mature predictive maintenance program. Well-designed, it can monitor process performance and maintain control with only periodic adjustments when necessary, and to also ensure not to over adjust. Regular monitoring of a process can save unnecessary inspection and adjustments. This information allows for a proactive response rather than a reactive response when it may be too late or costly. Control charts, clear and uncomplicated graphs of process information, are the key to an effective SPC program. Using control charts aid quality control analysts to monitor processes and identify any variation in the performance. Data from a stable, controlled process will only display common cause variation, i.e., only that variation which is inherent to the process. Control charts are based on aggregate past data that can be measured and predicted to determine how a process will vary (within limits of common cause variation) in the future. An unstable process will display a special cause variation, i.e., a non-random variation in the data. Quite simply, control charts are robust tools for understanding process variability and to analyze process performance. Finally, statistical process control is instrumental where precision matters in the production of components. Statistical analysis allows quality control analysts and engineers alike to analyze data, and to control and monitor production and procedures during validation and verification. Implementing a well-designed and comprehensive SPC system will improve your product quality. An SPC system benefits manufacturers and companies by providing historical benchmarks to relate to daily and long-term process performance of products, which will in turn, greatly aid the release and delivery of a safe and effective medical device to the marketplace.

Injection blow molding and plastic injection molding have an important role in the custom manufacturing of reusable and disposable plastic parts that are used worldwide in the research and biomedical fields, and in medical diagnostic laboratories. OEMs can produce a wide variety of specimen containers, bottles, vials, beakers and the like, sterile and non-sterile. Because applications vary, materials range from custom formulated polymers to polyethylene, polycarbonate, polypropylene, and thermoplastics. Nevertheless, whether the manufacturer utilizes blow molding or injection molding depends on the product. Each method of molding uses a different process and, as a result, there are several ways in which they differ.

The Origins of Blow Molding

Blow molding originated and evolved from the age-old art of glassblowing. A patent for extruding a celluloid polymer by blowing, or pushing, air into a mold was issued in the 1880s. Blow molding is an extrusion method where molten plastic is pushed through a two-dimensional die opening into a mold cavity, inflating it in the cavity with compressed air until the molten form gets its desired shape. The part is then cooled before removing from the mold. In blow molding, the finished products produce linear shapes and have two-dimensional forms which are continuous in length.

What is Injection Molding?

Injection molding is a process that evolved out of and is based on the molten die-casting method. First developed in the 1930s by melting plastic and injecting it into a predesigned mold, its advantages include a minimal loss of scrap and finishing requirements, and near 100% recycling. The injection-molding machine consists of two essentials: the actual injection unit and the clamping unit. Unlike extrusion, injection molding also forms three-dimensional shapes.

Solid or Hollow Parts

The most obvious differences in determining which method of molding will be used are related to the kind of product that will be manufactured. In general, blow molding is used to make singular, hollow products like bottles and beakers. Injection molding makes solid parts, like plates and discs, or is used to produce solid parts or pieces for plastic products. Talk to Our Experts! Request More Info! Wall thickness of the product is also an important difference between the two methods. In blow molding, wall thickness varies depending on how much the plastic is stretched as it is blown. The wall thickness of a part made by injection molding is determined by the mold itself and the core relationship. How the molds are made varies between the two, as well. In addition to making the mold, the type of plastic, the process temperature, velocity and pressure of the air blown and its speed are all key factors that have to be administered precisely in blow molding. Injection molding is all about the mold itself, approximately 90% of the process. Plastic resins are melted and injected with force into the mold to create the solid part or piece.

The Injection-Blow Molding Processes

The processes of molding between the two methods are different, too. Blow molding machines consist of three major parts: the extruder, accumulator die and product molds that differ in shapes and sizes. Blow molded containers require a parison, i.e., a plastic tube being heated and filled with air. The parison is inserted into the blow molding machine and the mold is clamped around the tube until the parison is formed in the shape of the part. During the injection molding process, melted material is injected into a mold, which is held under intense pressure. Once the material has solidified, it is ejected and the mold is filled again. In the plastic manufacturing of parts, objects, and pieces, blow molding and injection molding are both common methods to produce the products used on a global market. While injection molding and blow molding may seem similar, there are major differences between the two methods that are ultimately determined by the manufacturer’s needs.

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.

A Little Bit About Medical Contract Manufacturing Services

Contract manufacturing is a form of outsourcing in which a company produces whole products or a single part a larger product. This is true in the medical device industry, as well. OEM (Original Equipment Manufacturer) of medical devices are companies that, in general, focus on a particular area of expertise, such as molding, assembly, or R&D design. Medical device contract manufacturing is the system by which a manufacturing company makes medical devices or components of medical devices that can be later sold by another company.

Medical device contract manufacturers often specialize in a certain process or task and can offer expertise from frequent practice of their manufacturing. Service or services for customers, clients, and inventors of medical devices include product concept and development, process validation and verification, production, or highly specialized manufacturing, packaging. They can even manage the supply and delivery to the end customer.

OEMs can also provide specialized facilities that are essential for the manufacturing of medical devices. On-site medical labs are necessary for all phases of production, from design to manufacturing. These labs afford engineers with the chance to validate and verify new products and allow for any design changes that may be necessitated as needed. Cleanrooms are also required to ensure the manufacture of medical devices is free of contaminants. A cleanroom utilizes advanced filters, specialized clothing, and even hermetically seals the workspace.

What is Medical Contract Manufacturing?

To be certain, the term "medical device" covers a broad range of products. They can be found in the operating room, labor and delivery, nursing homes, intensive care units, home health care, sleep labs, your local pharmacy, and many other places. Nevertheless, all medical devices sold in the U.S. are regulated by the FDA (Food and Drug Administration). By FDA definition a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body. The regulatory policy for these devices is strict and follows a three tiered classification system, i.e., Class I, II, and III.

When You Need an Experienced OEM Contract Manufacturer

As an OEM contract manufacturer, BMP Medical provides services for the medical device industry. Its area of specialty produces highly precise plastic consumables used in devices and diagnostic kits. BMP Medical will work with its customers through all phases of production. We offer state-of-the-art injection blow molding capabilities to produce an array of IVD & IV components, sample preparation devices, and lateral flow technologies. We can offer design consultation, engineering, drawing, R&D, tooling, mold development, computer automation, and statistical process control for mid-tier products. Our facility is equipped with a Class 8 clean room for manufacturing, packaging, and assembly needs.

As a single source provider, BMP is geared to meet all regulatory requirements for medical device engineering. Sterilization services, custom packaging, pad printing, DNase/RNase free manufacturing, and process validation services to support any complex product development cycle are all available to BMP’s customers. The company has established the most rigorous quality control standards possible; especially for Class 1 medical device approval and 510K filing specifications.

Finally, to meet the needs of our clients and customers, BMP offers manufacturing facilities in Massachusetts and Asia, we can service any complex project requirement worldwide. Our devices have assisted a wide variety of industries ranging from diagnostic, laboratory, and research to biomedical, clinical, medical, and pathology devices. BMP is both ISO 13485 and 9001:2008 compliant, and conforms to standards set by the FDA, cGMP, LPA, ANSI, AAMI, and SPE. This is why, as an OEM of medical devices, pharmaceutical and medical companies have looked to BMP Medical to manufacture their medical devices for over 30 years. If you have any questions, feel free to Contact us!

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.

Such products are intended for use in the collection, preparation, and examination of tissue or blood samples taken from the human body. IVD can also be used to identify patients who are likely to benefit from specific treatments or therapies through next-generation sequencing tests. This method scans a person’s DNA to detect genomic variations. Devices include general purpose lab equipment, reagents, or test kits that may include monoclonal antibody technology.

An IVD, as with any medical device, must go through a series of tests to receive FDA approval before the product can be brought to market. The product development, design, and delivery cycle can be grueling to the uninitiated. To successfully develop and design IVD products, assembling an experienced team can ensure timely delivery of the device. This may comprise inventors, engineers, scientists, compliance experts, and an OEM (Original Equipment Manufacturer).  Once assembled, follow 3 crucial steps in ensuring your products’ design for manufacturability elements that will result in timely, compliant, efficient production and delivery schedule.

Customer and Client Needs

When considering any type of IVD medical device design, it’s important that it meets the needs of its end users. Getting feedback and gaining perspective along the way can mean the difference between success or failure of any product. Determine how users want to interact with the product, what their preferences are, and whether it will perform a desired function. By conducting such field research, companies can avoid costly product redesign and avoid weak market acceptance upon launch. Identifying desired features and intended functions of an IVD from all parties, from marketing to regulatory control, from safety to design personnel, will ensure success. Include your OEM during the design process by involving their compliance experts, production staff, and quality control personnel.

Simulation Modeling

A computer-based simulation model can be of great assistance in observing interactions and anticipating conflicts in product design. Simulation modeling will ensure your device functions efficiently and as intended. The program can prioritize features such as operational performance, process technology, and resolve other problematic or unforeseen complexities or even costs. It can reveal design challenges, where they exist, and how to adjust or correct them.

Choosing the Right OEM Reduces Time and Costs

Your goal is to successfully introduce your IVD medical device on the marketplace as soon as possible. To do so your IVD must be compliant. IVDs are subject to the approval of regulatory authority. FDA classifies IVD products into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The classification of an IVD medical device determines the appropriate premarket process. There is no compromise on this process. However, the right OEM for your product will be able to save time and costs through greater efficiency. An experienced OEM can bring off-the-shelf (OTS) solutions to adapt to a customer’s needs. All the necessary components to manufacture are already in place. Modules for newly designed diagnostic instruments may interoperate with existing system components. Some OTS solutions may be scalable or flexible to integrate in verified prior applications to apply to your device. An experienced medical device OEM has had a long time to develop OTS solutions that may adapt to your device and meet compliance in a timely and efficient manner.

Over the years, BMP Medical has worked with many clients to develop very intricate designs and features that set them apart from other IVD products on the market. We work closely with our customers to provide support for the design and the ability to manufacture their product. Our success rests on what we know since it’s what we do.

For more information, please contact us today!

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.

What is the validation process?

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.

What products need to be verified?

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.

Are there compliance protocols in place?

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.