Quality in 2013 Part 3: Q&A with May Sayco, Industry Solution Director, Medical Device

December 20, 2012

By Christian Rockwell


The medical device industry is a highly-competitive arena, and earning market recognition depends on the ability to keep innovating. With more devices and applications being used to treat patients, medical device companies are working to balance the demands of meeting regulations and producing safe and reliable equipment.  

Today, Sparta discusses some of the challenges the medical device industry faces in 2013 and the emphasis to improve quality and reduce risk.

What quality-related challenges are facing your industry in 2013?

The level of scrutiny applied to the pharmaceutical industry is now relevant to medical device manufacturers.  This is primarily due to the competitive landscape of medical devices and their shorter product lifecycle. Regulators realize the complexities of life-saving devices being implanted in patients like pacemakers, joint replacements and stents and are enforcing stricter guidelines to ensure consumer safety.

Once overlooked by regulators, the medical device industry is embracing technology to help physicians diagnose, prevent and treat patients. The medical device industry is broken into three classes; Class III being the most complex and most regulated.  Based on classification, devices must meet premarket approval to ensure safety and effectiveness. Manufacturers are under more pressure than ever to provide government authorities with the data needed to remain compliant, in a timely manner and make sure suppliers’ assembly lines are following the same quality processes to ensure manufacture of quality products.

This information is not only necessary to bring products to market, but is needed to monitor devices in production to make sure there are no adverse reactions for consumers and verifying that they are used as intended. Suppliers have to follow regulations for post-manufacturing requirements that are several years past the distribution date making product recalls extremely challenging in recovering back from consumers.

Internationally, the maturity level or harmonization of regulations isn’t quite there. The industry is shifting gears towards monitoring high-risk devices and forcing global manufacturers to drastically change current business models which could result in longer development times, delays in product approvals by regulators, or lags in product innovation due to higher taxes to stay in business.

What problems arise in this type of situation?

The product lifecycle from developed to sold can be a few weeks to a few years. Compared to the pharmaceutical lifecycle, which could last 12 years, medical devices are rapidly growing and infiltrating a highly competitive landscape to be the market-leader.

Current business models are not well equipped to meet consumer safety requirements, making recalls more prevalent and the driving force behind regulators’ demands. Medical device products and supply chains were not as enforced with simpler technologies in device designs to establish workflows that incorporate quality practices across multiple cross-functional departments to help mitigate risks. Often times, it’s far into the manufacturing or distribution supply chain before manufacturers were notified of discrepancies.  

The diversity of medical products is also catching the attention of government regulators. Technology is changing the landscape of medical devices, for example mobile applications are being used to diagnosis and treat patients. These mobile applications are considered medical devices and need to follow the same guidelines as bandage suppliers and pacemaker manufacturers. To comply, companies offering such services need to realign existing business processes because they are forced to adhere to completely new or ambiguous regulations that were not in place when they started developing solutions or are still in the process of being further defined by both the industry and regulators.

With pressure to improve clinical studies and product development, medical device companies may look for cheaper suppliers that operate with lower quality standards. The globalized supply chain is forcing the FDA to standardize quality processes and demand insight into clinical and design data in the early stages of product development.  

How does this type of situation affect quality control?

The FDA’s emphasis on reporting requirements and the number of products in use are contributing to the increasing recall rate. Medical device manufacturers must have quality assurance and quality management processes in place to have aligned procedures and provide the information required to regulators.

Strong quality assurance processes allow a company to manage operational issues and enhance product portfolio planning, making sure they have the infrastructure to support the competitive landscape. Having the proper procedures outlined will communicate any nonconformance components that aren’t being met. Quality assurance can help automate complaints and report data to regulators in a more timely and accurate manner.

Quality control processes will help medical device manufacturers create check points to ensure design and development is done appropriately. By establishing these processes, medical device companies can track and manage all the elements and requirements considered safe and effective products for consumers.  

Improving quality assurance and quality control processes will give medical device companies the tools needed to open communication and visibility across the business supply chain to minimize and eliminate gaps to ensure safe and effective products make it to market.

What are some best practices for managing and identifying risk across the industry?

Regulators are enforcing medical device companies to utilize technology to meet vigilant industry and compliance requirements while increasing response time to all critical operations.

In the coming years it’s going to be a challenge for companies to change the way they operate to increase operational efficiencies.  Implementing an enterprise quality management system (EQMS) will give companies the support they need to adhere to regulatory demands and timely oversight to all critical operations throughout the product lifecycle, whether it spans 12 days or 12 years.

Now that medical device companies are having to meet the same standards as the pharmaceutical industry, manufacturers will have need equivalent solutions to handle nonconformances and product deviations to determine the root cause and mitigate any potential risks before the product is out the door.

Medical device companies are finding the opportunity in being compliant and are making efforts to improve quality across the industry. An EQMS provides a centralized gateway to track and manage all phases of the product lifecycle to give companies streamlined access and transparency of data needed to make safety-related improvements and ultimately, quality products.

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