The three pillars of the life sciences industry

The dilemma for quality leaders

Quality Management System (QMS) process complexity and variability is an industry-wide, systematic problem that brings a heavy burden of cost and risk. The pace of innovation and disruptive nature of novel product are equally both exciting and challenging from a quality enablement perspective.

The patient is becoming the center of the universe that the life sciences supply chain serves. The line separating that supply chain from the broader healthcare ecosystem blurs through this growing trend of patient-centricity.

That same supply chain becomes ever more complex as it is increasingly virtualized and outsourced. Simultaneously, the volume of acquisition and divestiture in the space continue to rise.

Much of this is driven by the reality that is Industry 4.0. This makes even measuring total cost of quality (TCoQ), let alone controlling or decreasing it, a far important and difficult endeavor. These macro trends sum up well, Mode 2 of the bi-modal challenge faced by industry today as it pulls in opposition to the day-to-day micro challenges of Mode 1.

And if this outlines Mode 2, Mode 1 can be well characterized by the five key imperatives front and center in the minds every quality leader on a daily basis:

• Product quality
• Product efficacy
• Patient safety
• Continuity of supply
• Compliance

And so, while that quality leader is buried under existing and growing pressures – complex change controls, customer complaints in the thousands, product recalls, inspections in multiple manufacturing sites at any given time – now they have the head of R&D asking for unique quality system capabilities to support of novel product and the head of engineering needs a quality system innovation for the digital ‘factory of the future’ that was recently approved.
 

Technology’s place as the third pillar

Traditionally, the manufacturer of medical product has partnered with the regulator to solve for the future-facing challenges the life sciences industry has faced in the realm of quality and compliance.

Often, these two pillars of industry – manufacturing and regulation – would engage expert consulting firms in this endeavor with great success, but also at great expense. The technology solution provider would then be asked only to deliver the enabler of the defined solution, having had little involvement in the ideation.

Thanks in part to the rise of the fourth industrial revolution, that is about to change. Now, the technology solution provider has a far better seat at the table.

Historically, in the discipline of quality management systems, rarely would a medical products manufacturer look to their QMS provider for deep, strategic, and disruptive innovation that would deliver a significant business transformation.

Industry 4.0 has brought into view such disruptive technologies as artificial intelligence (AI) and the Internet of Things (IoT), amongst others.

Harnessing the power of these innovations has elevated and accelerated the ability to facilitate, to catalyze, to unleash the full potential of the novel products, treatments, and therapeutic services the manufacturers are bringing to the market.

It is imperative that technology providers’ relationships with regulators are elevated so that the role, the accountability, the value is recognized and championed by them as much as it needs to be by the manufacturers.

These three pillars of this industry have an ethical obligation to use the innovations afforded to us in the service of public health. Only together in selfless and passionate collaboration, can we ultimately uphold the future health and wellness of the global population.

Sparta Systems shares insights about macro and micro industry trends that affect quality in such a bi-modal manner.