Medical device companies typically have a complex supply chain bringing products to market. Within their four walls, there are usually multiple business units responsible for different segments of developing, manufacturing, and delivering products to the consumer. Most companies also have multiple manufacturing sites making both different and the same product. When the same product is manufactured in multiple sites, its success is dependent on consistency. However, multiple sites and business units may have unique and disconnected systems, making it possible for consistency to fall through the cracks.

Fig. 1 – Medical device industry challenges.
As companies in all industries looked for ways to expand their reach, bottom line, and market share in the early years of manufacturing, cost was king. Due to current competitive market pressures, companies are still looking for ways to cut costs in the development, manufacture, and distribution of products. This has led to the growth of contract manufacturing and materials used in manufacturing coming from suppliers globally. These contractors and suppliers often also use contractors and suppliers (subtier), so there are many layers of companies providing everything from raw materials to finished products. The decision to use contractors, or determining which suppliers to use, is typically made by finance and purchasing departments. While quality specifications are written, purchasing usually makes the assumption that all potential suppliers or contract manufacturers meet the necessary quality specifications and the decision is weighed on price and ability to deliver when needed.

Each contract manufacturer and supplier has their own internal ways to track and manage quality. Some have robust systems while others have little or nothing in place. The problem with this approach is that the company responsible for the product has little or no visibility into the day-to-day quality issues happening throughout the supply chain that may affect the finished product. The challenges with managing suppliers and contract manufacturers coupled with disparate quality functions, systems, and processes across a manufacturer’s own enterprise can create a challenging environment to manage quality holistically, which, in turn, increases IT costs, makes an organization less efficient, exposes the supply chain, and puts manufacturers at risk for significant consumer facing quality issues. Figure 1 shows the industry challenges faced by medical device companies today.

Outsourcing Issues

As part of the growth and diversification efforts of manufacturers in the 20th century, many companies began identifying and managing core competencies while outsourcing the rest, such as commodity or ancillary services. However, outsourcing issues can quickly arise if every aspect of bringing a product to market isn’t handled with the highest level of quality embedded within the process. Disconnected and isolated systems often lead to severe risks and challenges for all those involved, and can potentially result in grave implications for the company whose name goes on the label.

A recent example of mismanaged quality would be the silicone breast implants made by Poly Implant Prothése (PIP) in France. The company’s product was banned in 2010 due to the use of an unauthorized silicone filler, causing double the rupture rate of other implants. About 300,000 women in 65 countries were believed to be affected. Although there was no direct health threat to the patients, PIP no longer exists, and the founder, Jean-Claude Mas, has been sentenenced to four years in prison for fraud. Also, the German firm responsible for granting European safety certificates for the implants is required to pay compensation to hundreds of affected women.

To help improve efficiency, integrity, and quality of various aspects of the manufacturing process for medical devices, such as outsourced preclinical and clinical trials, manufacturers have— or should—adopt quality management software (QMS) to automate and streamline workflow processes, increase transparency, and improve compliance with various global regulatory protocols. By tracking and managing quality and compliance, QMS helps manage incidents and provide structured audit programs, associated corrective and preventative actions (CAPAs), and analyses and approvals of changes, such as protocol amendments, trial registration, documentation, and SOPs. The benefit of having quality and compliance procedures built into a single quality solution is that CAPAs and effectiveness checks can be easily tracked to ensure continual monitoring and improvement of trial processes. Further, ubiquity of mobile access has led to developments of mobile quality management applications to help manage on-the-go resources and expedite the approval process, no matter a manufacturer or outsourced partners’ location.

Fig. 2 – Managing global contract manufacturers, suppliers, etc.
When used as clinical trial management systems, quality management software provides organizations with a webbased solution that helps track, manage, and control clinical trial processes and tasks, ensuring that problems are identified and addressed in accordance with good clinical practices. As a result, all stakeholders, including senior management, trial managers, regulatory affairs personnel, and more have complete visibility into the current status of all trials and activities. This includes product safety issues and any related actions critical to the success of a program, such as the tracking and resolution of serious adverse events and the associated regulatory assessments and reporting processes. Quality management software also makes all trial activities and information accessible across multiple sites, studies, and teams, which is extremely important given the increasingly globalized nature of manufacturing.

The benefits of QMS during contracted preclinical/clinical trials also include the ability to track clinical projects for sponsors on regulatory approval, ethics committee review, device availability for studies, and annual reporting to countries of submission. Internal and external audits of clinical laboratories, clinical sites, suppliers, internal processes, etc., may also be conducted in order to manage the observations, CAPAs, and change control processes in a closelooped system.

Typically, outsourced companies do not have insight into the quality processes, traceability of components, or reliability of designs. In these instances, change control is extremely important, and easily streamlined through the help of an enterprise quality management system. Figure 2 represents an ideal vision for managing the complex web of global contract manufacturers, suppliers, etc.

Here, change control is interwoven with multiple elements of an enterprise quality management system (EQMS), including deviation management, audits, regulatory reporting (registration tracking, eMDR/eMDV, UDI), CAPA, and training management. This provides enabling full lifecycle management and seamless integration to other quality processes across different business areas, such as regulatory affairs. Data centralization provides clear visibility to all levels of the organization by enabling more effective trending and reporting for timely and impactful decision- making. The benefits of managing change within the EQMS go beyond quality management. For example, medical device manufacturers benefit from improved cycle times and time-to-market, improved product quality, and flexibility to adapt to changing market requirements and regulations.

Additive Manufacturing

Another software breakthrough helping bring medical devices to market faster is additive manufacturing, commonly known as 3D printing. Rather than subtractive methods such as milling, shaving, or drilling to remove unnecessary materials from a large piece of raw material, additive manufacturing adds a thin layer of material only where needed, layer by layer. The process is faster and more accurate, enabling fabrication of complex parts with almost no waste. Additionally, having an EQMS in place to manage shipments of raw materials, quality checking materials on-site and throughout the manufacturing process, companies will save the costs associated with scrapped materials or costly product recalls.

When it comes to medical device additive manufacturing, the FDA regulates how the quality processes must be managed, noting that quality systems must be in place to ensure patient safety as governed by the FDA’s cGMP requirements. Quality management must be integrated with the additive manufacturing processes during each step to ensure accuracy, quality, and compliance for patient/product safety.

The additive manufacturing market is growing rapidly. Currently, surgical equipment accounts for the largest share in this market due to their wide applicability. In 2012, the global additive manufacturing market was $1.8 billion, and is expected to grow at CAGR of 13.5 percent to reach $3.4 billion by 2017, according to a report by MarketsandMarkets, a global market research and consulting company. See www.marketsandmarkets.com/Market-Reports/additive-manufacturing-medicaldevices-market-843.html .

Companies that adopt additive manufacturing reap many benefits, including the ability to produce unique or one-off items, such as patient-specific implants, as well as a shorter lead time for prototyping. However, another method that enables faster time to market is rapid application prototyping (RAP), which favors planning software to design, revise and test prototypes within the software itself. Integrating EQMS as part of the RAP process or change control will bring dividends in efficiency and faster time to market through effective regulatory approvals. This also allows manufacturers to respond quickly to adverse events and adjust designs accordingly.

The common factor in all of these software trends is quality. When manufacturers have a lack of control or visibility over its suppliers, partners, or the supply chain as a whole, the result is inferior products that have an increased likelihood of reliability and safety issues. There must be consistent processes, a harmonized approach to safety and riskbased management of issues, suppliers, standards, materials, and collaboration, or else manufacturers increase the risk of a recall resulting in added costs and a negative reputation for their brand.

Quality, Not Cost, Is King

Quality is non-negotiable regardless of what the product is, what its value is, or how it is used by businesses or consumers. When medical devices—and, potentially, a person’s life—are on the line, this truth increases ten-fold or even one hundred-fold. Quality is a process that is continuous, built from the ground up, and transcends the value chain. To effectively manage quality in the current global marketplace, global supply chain, and complex product life cycles, companies must have reliable people, processes, and technology.

People: Ensure you have created a culture that is top-down, with employees trained on the quality paradigm or blueprint. This should include your partners, suppliers, and all outside/ contract manufacturers.

Process: Define processes to manage every step during the life cycle of a product. These processes are not one-size-fits-all, and they must be flexible as part of the continuous improvement to comply under regulatory and quality requirements. Some processes include supplier quality management, audit management, CAPA, customer complaints, etc.

Technology: To effectively and efficiently manage quality, manufacturers must have the tools that can provide repeatable and predictable results, which provide information in a timely manner to the appropriate personnel to make effective decisions.

Businesses have discovered the hard way that the reliability and quality of their core product or service must remain a top priority, even if cost used to be king.

This article was written by Mohan Ponnudurai, an Industry Solution Director at Sparta Systems Inc., Hamilton, NJ. For more information, Click Here " target="_blank">http://info.hotims.com/49743-160.

Medical Design Briefs Magazine

This article first appeared in the March, 2014 issue of Medical Design Briefs Magazine.

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