Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

Medical device manufacturers have significant challenges to design and deliver safe devices. Navigating regulations is one thing, but incorporating emerging and continually evolving technologies requires device companies to raise their game if they want to stay ahead of the competition and leverage artificial intelligence (AI), machine learning (ML), augmented reality (AR), the Internet of Things (IoT), and robotics, just to name a few. There are so many technologies converging, a term has been given to describe the new manufacturing landscape—Quality 4.0. Quality 4.0 refers to Industry 4.0, also known as the fourth industrial revolution.

Prior to the fourth revolution, the first revolution started with machine manufacturing, steam power, and agriculturalists’ move to cities. In the second industrial revolution, production was automated and mass manufacturing cut the cost of consumer and industrial products. The third revolution involved the use of electronics and control systems in manufacturing, which helped drive down costs and resulted in increased product complexity and lower product costs. Today’s fourth industrial revolutionary change is driving new quality paradigms, processes, and technologies.1

1. Transformational Technologies
Industry 4.0 represents the dawn of the digital transformation that began with the third revolution, connecting the physical and natural worlds. The impact of digital data, analytics, connectivity, scalability, and collaboration are the drivers empowering this fourth industrial revolution and informing Quality 4.0 strategies. As we find new ways to connect people, devices, and data, the democratization of technologies is introducing transformative capabilities in analytics, material science, and connectivity. For the medical device industry, such technologies empower a quality transformation of culture, leadership, collaboration, and standards.

Quality 4.0 is reshaping device designs, functionality, manufacturing processes, supply chain strategy, customer service, and the methods of maintaining quality systems compliant with regulatory bodies. Intelligent and connected technologies are rapidly becoming more widely used as manufacturers seek an advantage to introduce inventive products to market and leapfrog existing competitors.

2. Analyst Insights
MarketsandMarkets forecasts the medical device market will grow to $63.43 billion by 2023. Smarter, more automated, and connected devices are improving the state of healthcare, making it possible to perform remote surgeries with doctors on the other side of the globe. Medical device companies’ ability to leverage Quality 4.0 technologies will be key to market success in the years ahead. LNS Research sees Quality 4.0—the application of Industry 4.0 technologies to quality initiatives—as following IoT’s path. Industry experts have determined a quarter of medical device manufacturers’ digital transformation technologies drive quality improvements.1 These same technologies are being used to design and deliver products. What does this mean for medical device manufacturers?      

For starters, digital transformation trends have helped define Quality 4.0 strategies to eliminate reliance on disparate paper-based quality management systems and processes. The move away from manual systems reduces errors, silos, collaboration barriers, and traceability issues. Furthermore, the digitization and automation of design and production processes enable small and global companies to scale their design and supply chain processes quickly. For instance, one such company, RefleXion Medical, a leader in biology-guided radiotherapy systems for cancer treatment, knew they needed to implement a completely connected quality management system (QMS) that could scale to support their path to digital transformation and improved compliance. They required a flexible platform that could grow with their team, products, and path throughout the quality compliance process.

3. Improving Compliance for Complex Medical Device Companies
Modern medical device manufacturers rely on distributed teams and supply chains, including design partners, contract manufacturers, and tiered component suppliers to speed product development and launches. Companies that have embraced new technologies and cloud-based systems understand the benefits digital transformation technologies can bring to a device manufacturer’s product requirements, product capabilities, and regulatory compliance objectives.

In the life sciences realm, digital therapeutics, medical diagnostic equipment, implantable devices, and disposable devices are just a few of the wide array of devices striving to be problem-free while delivering higher throughput and maintaining compliance.

Medical device and equipment manufacturers must overcome many challenges as they move from early concept and design through commercialization. Taking advantage of Quality 4.0 technologies can help at every stage of the new product development (NPD) and new introduction (NPI) processes to deliver high-quality and safe devices. However, manufacturers are finding Quality 4.0-influenced designs and quality processes can only be achieved by adopting a newer and higher standard for quality that is driven from leadership and embraced by everyone involved during the product realization journey.

4. Connected Quality Supports Quality 4.0
To meet the demands created by Quality 4.0 trends, companies should adopt a more connected, or product-centric, QMS approach. As complexity of products increases with AI, IoT, robotics, and related 4.0 technologies, quality teams must have a unified system to identify issues, address audits, and resolve quality incidents. Older, antiquated document-centric QMS approaches create too many blind spots. Product-centric QMS is founded on maintaining the full, complex product design comprised of electrical, mechanical, and software components in a single system. This foundation allows for complete, connected quality and corrective action records with direct linkage to every aspect of the underlying product design. This connected methodology provides increased visibility and transparency as teams collaborate through each phase of NPD and NPI. With a product-centric QMS, medical device manufacturers can benefit in areas such as requirements, training, audit readiness, design controls, integration to upstream and downstream systems (e.g., CAD, ERP, CRM), supplier quality, and DHF/DMR control.

Furthermore, companies will gain competitive advantages by having more intelligence-driven product and quality process insights. This, in turn, will lead to better data-driven decisions and cross-functional visibility with quality, engineering, operations, and supply chain teams. These Quality 4.0 transformational technologies add product complexity, making it more difficult to meet strict medical device requirements (e.g., ISO 13485, FDA 21 CFR Part 11 and Part 820) with a traditional, document-centric QMS approach.

To simplify regulatory compliance, a product-centric QMS solution makes it possible to:

• Create a completely connected quality and product process.
• Establish quality product processes to avoid audit issues.
• Ensure traceable design and change controls.
• Manage product bills of materials (BOMs) linked directly to quality records.
• Drive closed-loop quality and CAPA processes to faster resolution.
• Improve quality compliance and supplier management processes.

The last point about supplier management process is essential because the right QMS solution can unify quality and product record management to provide complete control and traceability, simplify audits, and decrease risks.

5. Product-Centric QMS Speeds CAPA Resolution
Swan Valley Medical, a manufacturer of surgical instruments and accessories for urological applications, understood this very well before implementing a product-centric QMS solution. They were burdened with inefficient paper-based manual processes that resulted in potential compliance exposure due to misplacing critical documentation. When missing or inaccurate information was found during audits, it was difficult to recover and could take a couple hundred hours or even several months to do so.

With a cloud-based product-centric QMS solution, accelerated root-cause analysis and risk management observation processes were implemented. This enabled different processes to call the other ones by having linked product and quality records to support audits with cross-linked evidence chains.

Closed-loop CAPA processes help quality teams identify, analyze, and resolve quality issues faster. Pulse Biosciences deployed a closed-loop quality system across its organization. All team members were able to work collaboratively on the most current product definition and latest quality records with a product-centric QMS. With streamlined CAPA processes, Pulse Biosciences was able to address urgent corrective actions rapidly with better audit trails.

Medical device manufacturers are beginning to see the impact of Quality 4.0 and how new technologies are changing traditional quality strategies to take operational excellence, performance, and innovation to new heights. Medical device innovators are learning that supporting increasingly smart and complex products requires a better and more connected QMS approach to support converging technologies, digitization, and the full realm of Quality 4.0 trends.

For instance, Kinsa, which offers the first FDA-cleared, doctor-recommended Smart Thermometers, implemented a product-centric QMS to assist in the design of the company’s first-ever connected device. Application of Quality 4.0 technologies helped Kinsa revolutionize how healthcare can be reimagined in an IoT universe, where connected products support improved healthcare within communities. Kinsa can address its connected technologies with a product-centric QMS to streamline product development, improve quality management, and shorten the time to resolve customer issues.

The march to deliver more intelligent devices is moving full speed ahead. Both large, established medical device companies and smaller innovators are racing to improve healthcare by connecting people and data using newer technologies like IoT, AR, and robotics to deliver better outcomes to patients around the globe. Industry 4.0’s advances helped drive Quality 4.0 technologies and strategies to improve quality compliance. The ability to align complex product development and quality processes is critical to compete in today’s global economy. We not only develop products virtually with distributed teams, but thanks to intelligent robotics and AR devices we now have the ability to heal and perform surgeries where doctors and patients are separated by multiple time zones².

Consider your goals and realities for creating and delivering complex products that meet regulations from FDA to ISO. Make sure to create a completely traceable, reduced-risk environment to protect your patients as well as profits and long-term viability. Quality 4.0 trends require smarter, connected strategies to ensure your company isn’t left behind. 

References

1. https://blog.lnsresearch.com/quality40
2. http://bit.ly/2m9ta4H

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Scott Reedy spent a decade working in engineering and manufacturing and has helped drive new product development and introduction processes for global manufacturers. Over the past 20 years, Reedy has held strategic roles working for enterprise software companies and has helped many companies implement best practices to speed product development and product delivery. For more information, visit www.arenasolutions.com.