2019: The Year to Enhance Quality in Orthopedic Product Development

The world has gone digital, and now it’s time for orthopedic product developers and manufacturers to catch up. According to LNS Research, 60 percent of all organizations are investing in industrial transformation—otherwise known as digital transformation or Industry 4.0. While industrial transformation is a necessary step toward innovation and competitive market performance, it alone is not enough to guarantee business success. In tandem with Industry 4.0 initiatives, organizations must also pursue Quality 4.0 strategies—that is, they must fuse traditional quality methods with new technologies such as machine learning and artificial intelligence, big data, and cloud computing. Quality 4.0 solutions enable organizations to optimize their digital transformation initiatives and capture the business opportunities made possible through process efficiencies, enhanced service, improved compliance, and brand reputation.

Fourteen percent of today’s organizations are already pursuing Quality 4.0 strategies, with life sciences companies leading the charge. According to LNS Research’s principal analyst and research director Dan Jacob, “The life sciences sector is disproportionately engaged in Quality 4.0 innovation, which makes the pharmaceutical, medical devices, and biotech industries particularly relevant.” To stay ahead of the competition, orthopedic product developers and manufacturers must define and execute against forward-looking quality strategies. Customers will buy from providers who offer leading-edge solutions and services, and whom they trust. Here is what to know when creating a modern—and winning—quality strategy.

The Benefits of Next-Gen Quality Solutions
Sophisticated quality solutions that offer automation, data analytics, and other digital capabilities can deliver critical data insights to steer orthopedic businesses forward. For instance, using quality management system (QMS) solutions with advanced data analytics functionality, orthopedic organizations can more easily secure a comprehensive view of the entire business by mining data across departments. Information no longer has to exist in siloes; it can be used to efficiently tell a broader story about what’s happening at every level and in every aspect of a company. This empowers orthopedic product developers and manufacturers to make more intelligent decisions in real time (or near-real time) that support overall business performance.

Sophisticated QMS solutions can also help orthopedic product developers and manufacturers more easily mine for data—sometimes even for data they may not have even known existed. For instance, orthopedic product developers and manufacturers can use advanced QMS solutions with automation and data analytics capabilities to quickly detect and identify product defects. They can then address the defect before it escalates into a larger issue. This not only ensures they feel confident about what they’re offering customers and prospects, it can also accelerate time to market by catching and addressing issues early and improving new product development.

Now Is the Time to Embrace Quality 4.0
While the start of a new year is always an opportune time to implement new business approaches, the first quarter of 2019 is a particularly smart time for orthopedic product developers and manufacturers to invest in updated quality solutions. 

In the first quarter of 2019, the U.S. Food and Drug Administration (FDA) will advocate for a move from Computer Systems Validation (CSV) to Computer Software Assurance (CSA) for non-product software. Mandated by the FDA to ensure and document that computer-based systems produce information that meet a set of requirements, CSV has historically served as a critical compliance requirement and a key component of QMS solutions for medical device organizations, including orthopedic developers and manufacturers. Documentation includes defining precisely the purpose of the computer systems, the features they need, the hardware they require, when they will be used, and the requirements they are expected to meet.

The systems have historically been tested on a routine basis to confirm they continue to meet the predefined requirements. All CSV documentation could be called upon for review and audit at any point of the system lifecycle. Failure to produce proper, compliant CSV documentation has ranged from warning letters, to 483, to potential injunction, product seizure, and even criminal prosecution.

The CSV was initially designed to ensure product quality and patient safety, data integrity, data accuracy, and software effectiveness. However, evolving technologies and business circumstances have prompted the FDA to publish a draft guidance document to ensure organizations can more flexibly invest in new best quality practices and solutions—such as those afforded by automation and other digital technologies.

To put medical device organizations in a better position to learn, react to issues, and improve product quality, the FDA has set a new vision. Under this vision, value-driven and patient-focused approaches are used to streamline CSV and critical thinking, while risk-based, agile approaches are used to provide assurance activities and evidence capture.

Enter CSA. The CSA is a set of activities or actions performed to give confidence the software functions as intended and meets the organization’s needs. Whereas CSV prioritized documentation and testing activities, CSA focuses first and foremost on critical thinking and assurance needs, and the least burdensome approach.

According to Cisco Vicenty, CDRH program manager at the FDA, “The FDA supports and encourages the use of automation, information technology, and data solutions throughout the product lifecycle in the design, manufacturing, service, and support of medical devices. Automated systems provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk. These capabilities provide significant benefits in enhancing product quality and safety.”

According to Daniel Matlis, president of Axendia Inc., the transition to CSA will be supported by efforts to:

• Include new ways to assess organizational performance by focusing on quality and shifting from inspection,
• Adapt regulatory oversight to increase agility, responsiveness, simplification, error-proofing and continuous rapid improvement, and;
• Drive connections within systems to increase visibility into product quality and to enable market drivers.

All these transitional efforts provide a strong foundation for a change in QMS strategy among those in the medical device—and specifically the orthopedic product development—community. Processes that used to take months with CSV can now be completed in a matter of weeks. Plus, better quality processes can drive significant cost efficiencies for businesses. For organizations that relied on costly consultants and freelancers to complete critical quality tasks, QMS solutions with automation, data analytics, and other digital capabilities can now present a cost-effective alternative. Based on an analysis from the FDA-Industry CSV team’s analysis, shifting to AGILE Ad-hoc/Unscripted Testing could result in annual savings of $1.62 million for a $10 billion firm with 100 systems.

Setting Up for Quality 4.0 Success
To spearhead quality initiatives, it’s imperative orthopedic product developers and manufacturers first secure C-level support. Though business process owners will likely manage day-to-day quality processes, C-level buy-in helps to set the vision for a company’s quality initiative—including how quality strategies and solutions can be used to enhance results across departments and improve overall business performance. Increasingly, chief digital officers are overseeing these initiatives. That said, regardless of title, it’s important whoever drives quality programs embraces digital solutions and uses them to deliver tangible strategic business value.

Next, orthopedic manufacturing organizations should appoint a project owner (change leader)—often at the director or manager level—to identify and implement the QMS solution that will best meet the business goals set by the C-level executive. To identify and qualify QMS solutions, this person might:

• Hire a third party that specializes in helping companies identify and select the software solution to accelerate the process and provide an unbiased selection;
• Take a hybrid approach, using a third party to identify software solutions and internally assess those suppliers to select a final software solution; or
• Use only internal resources and complete the final selection process themselves.

Regardless of approach, key considerations should include what industries the vendors serve and what products they offer, with an eye toward:

• How the vendors can help them meet their objectives. Consider critical business questions such as: How can you help offset IT costs? How can you help ensure compliance?
• The sophistication of the vendor’s solution. Inquire about whether the vendor offers a solution that sits in the cloud and request a demo.
• What services the vendors provide. Look into whether the vendors offer services related to change management, implementation, training, and support management.
• Who else in the orthopedic industry uses the vendors’ solution. This will demonstrate subject matter expertise (or lack thereof).

Once the best provider is identified, organizations can implement the QMS solution and set themselves on the road to enhanced quality and better business outcomes.

Now is the time to embark on a Quality 4.0 journey. With the FDA’s support and with market competition heating up, those in the orthopedic product development industry are prime for QMS change. By introducing quality solutions that offer automation, data analytics, and digital technologies, orthopedic product developers will be able to intelligently integrate information across the organization, enhance impact analyses to streamline and error-proof design control, and support improved product quality. Don’t get stuck behind the curve: 2019 is the year to push ahead by investing in leading-edge solutions and processes that will set your company ahead of the competition. 

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Anthony Parise is a product strategist for life sciences at ETQ, a Burlington, Mass.-based leading provider of quality, EHS, and compliance management software trusted by some of the world’s strongest companies to secure brand reputation, transform insight into action, and help them focus on what matters most.