It is time for the life sciences industry to embrace quality 4.0

Oxana K. Pickeral, Ph.D., MBA, is president and CEO of Sparta systemsa Honeywell company.

The life science industry is facing unprecedented levels of change and transformation. On the bright side, the global biotech market surpassed $1 trillion in 2021 and is expected to grow 13.9% annually from 2022 to 2030. The troubling news is that quality and compliance events continue to plague the industry with 25% to 30% of pharmaceutical products production costs drained by quality problems.

More than 300 medicines and medical devices have been recalled in the past two years. It’s a big cost to the companies doing the recalls, but the cost of poor quality is more than recalled products. There is also the cost to patients as well as the risk to their health and safety. This is the overriding reason why the life science industry must focus on quality; patients depend on it for safe and effective medical products at the right time. Another major cost to the industry is reputational risk. Life sciences companies limit their ability to deliver their innovations and achieve market growth – and improved clinical outcomes – if patients do not trust their products.

Rise Of Quality 4.0

We can solve these challenges by embracing Quality 4.0. It is an approach that blends traditional quality assurance methods with new Industry 4.0 technologies – such as artificial intelligence, big data, automation and IoT – to improve quality, reduce costs, facilitate compliance and increase the efficiency of quality operations.

How can life sciences organizations connect the “data points” to deliver on the promise of Quality 4.0 and realize the value it can bring to their businesses, customers and patients? One way is by enabling a connected life sciences ecosystem that provides a closed-loop feedback process of quality, manufacturing, supplier and regulatory data across the product lifecycle. This vision rests on three interrelated elements, all of which have patients at the center.

The first element is proactive quality, enabled by digital, end-to-end management of critical quality processes. Proactive quality involves harmonizing people, culture, technology and processes to identify and correct problems early in near real time. It’s about cultivating a proactive – and ultimately predictive – mindset inside and outside your organization.

The second element is intelligent operations. This includes features such as batch automation, control and visualization to promote quality and manufacturing excellence in a connected facility. Intelligent operations rely on quality and operational data being available and actionable – easy to obtain, integrate and analyze – all in near real time.

The final piece of the puzzle is an integrated ecosystem. The key here is more secure, end-to-end supply chain visibility from the lab to the patient. This integrated ecosystem is critical to improving product availability and integrity and ensuring patient safety.

Quality 4.0 is a journey, not a destination. Here are three ways to help make it a smooth one.

1. Check data availability

It takes more than technology to realize the value of Quality 4.0. Your data must be ready for digital transformation. Check that it is accurate, current, complete, concise, relevant, available and accessible. Also, make sure your teams understand Why behind your 4.0 initiatives and the behaviors you want to drive, such as improved productivity and the ability to make data-driven decisions.

2. Focus on results rather than technology

Don’t make digital for digital’s sake. Start with the end in mind. Consider the business and patient outcomes you want to achieve and look for solutions that can provide choice and interoperability that fit your infrastructure and technology environment. To assess performance against desired outcomes, it is important to measure key performance indicators (KPIs) based on areas such as supplier quality. An example in this area is the supplier risk score, which can help you better manage and develop your supplier network based on objective qualitative and quantitative factors.

3. Don’t spread yourself too thin

Analyze your most pressing business problems with a scope that is possible based on your resources and capabilities. Look for partners that have the depth of domain and capabilities to get you started. Start small, learn, pivot and scale quickly. Solving big problems matters, but starting with a realistic scope can provide a quick win you can continue to build on. The key is to pick the right problems from the start and make them both meaningful and manageable.

Quality 4.0 in action

Keeping up with the pace of change requires effort, but the payoff can be massive. Imagine the possibilities when a company can draw on data from across the enterprise and ecosystem, deliver unified reporting at the touch of a button, and much more.

Nearly two-thirds of respondents to a BCG survey say Quality 4.0 will have a significant impact on their operations by 2024. Respondents identified key manufacturing use cases as predictive quality, machine vision quality control, and digital standard operating procedures (SOPs).

We see this effect today. We worked with a medical device manufacturer that was struggling to deal with tens of thousands of complaints each month. It needed to improve efficiency and effectiveness without sacrificing accuracy and compliance, so it turned to Quality 4.0 and AI to automate its complaint handling process.

The manufacturer can now predict the reportability of post-marketing complaints almost 100% of the time, enabling faster identification and throughput. This means that the team can focus its attention on high-value activities, such as critical records management and effective root cause analysis, resulting in 48% more high-priority complaints being closed.

The value of transformational quality management and its impact on life sciences and patients is significant. It is a digital race to deliver secure and efficient products and services faster. Therefore, now is the time to take the first step towards Quality 4.0.


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It is time for the life sciences industry to embrace quality 4.0

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