Proactive quality is the ultimate goal in life sciences—with the advent of innovations like AI and IoT in the quality management ecosystem, proactive quality is finally becoming a reality.

While the industry faces unprecedented challenges, there are also opportunities to serve the patient like never before, both of which require innovation in their business and product and in their approach to quality.

Some of the more significant challenges facing life sciences quality leaders today include these seven macro trends:

1 Process Complexity and Variability

Quality process complexity and variability are systemic, deep-rooted problems that impact product quality and compliance and increase risk and associated costs. The number of mergers and acquisitions has never been higher across the Life Sciences value chain. Acquisition integration brings even more complexity and variability to a business as it acquires another set of quality processes along with its newly added division. On top of this, acquired companies rarely adopt the existing quality system processes. While a firm can have solid KPIs and mature metrics and dashboards, it cannot compare apples to apples, site to site, if each location executes different processes. These processes must be modular and scalable, and the digital platform that delivers them must be able to dial up or down the applicable level of rigor.

2 Pace of Innovation

A decade of technological advancements, as well as unique challenges posed by the novel coronavirus, accelerated the demand for rapid innovation, increasing the pressure on quality teams to ensure effective, compliant processes and product efficacy at every stage.

How can quality professionals adapt to these increasing pressures? Some of the same digital tools and approaches that have ramped up the pace of innovation (like AI, the internet of things and big data) can help organizations manage these challenges—and contribute to growth within and the Life Sciences industry.

3 Industry 4.0

The disruptions introduced by Industry 4.0 have fundamentally altered the Life Sciences industry, transforming it into the “Factory of the Future.” IoT and smart sensors are transforming the manufacturing process, and 3D printing has radically disrupted orthopedic and other medical device production. The Industry 4.0 framework digitizes and integrates vertical and horizontal value chains, further digitizing product and service offerings, business models and customer access. Perhaps most importantly, data and analytics now sit at the core of the value chain.

4 Patient Centricity

A patient-centric view recognizes the patient at the core—and their increasing power. The typical supply chain operations reference mode (SCOR) model of “Plan, Source, Make, Deliver” is rapidly expanding past the manufacturer’s warehouse and the hospital’s receiving dock to the treatment room and patient’s home.

5 Novel Medical Product

Patient centricity can also be attributed to the creation of many novel medical products—such as 3D-printed or digital medical devices—resulting from the fourth industrial revolution. The patient will have increasingly greater influence over changes made to value chains that uphold the health and wellness of the global population. Products and services will be increasingly customized for patient needs.

6 Supply Chain Complexity

The level of outsourcing to contract manufacturing organizations (CMOs) is higher than it has ever been. Not only is the amount of outsourcing high and increasing, but also the nature of the companies to which that outsourcing is going is changing. Ventilator medical device manufactures have outsourced production to automotive or even vacuum cleaner manufacturers in the fight against the COVID-19 pandemic. Such partnerships may be necessary and highly successful, but they cannot occur without increased levels of risk and QMS complexity and reliance.

7 Total Cost of Quality (TCoQ

Achieving optimal TCoQ is only possible if an organization can first measure it.  However, businesses often do not capture the data they need. Or, they may not have access to the data because it’s siloed in another department or takes place outside of the organization, perhaps with its supply chain partners. Businesses also frequently can’t easily consolidate the information because it’s in different formats or different systems. Proactive QMS capabilities that deliver data-centric solutions—integrated seamlessly throughout the broader value chain system architecture—can have a significant positive impact on a company’s ability to face this enormous challenge.

Alleviate these Challenges and Accelerate Your Path toward Proactive Quality

Get deeper insights into these seven macro industry trends by downloading the white paper below. This paper will illuminate challenges and opportunities, explore the bi-modal challenge quality professionals are faced with, and detail why quality technology is a critical enabler for Life Science companies.