Digital Transformation in Contract Manufacturing Industry Trends

In much the same way that scientists have been able to transform the traditional paper crane into the latest collapsible cardiac stent or space telescope, contract manufacturers can use contract manufacturing software to scale up and down with ease to match current market demands.

According to Robert Lang, origami expert, software program developer, Ted Talk presenter, and a keynote speaker at MasterControl's largest annual user conference, Masters Summit, “The secret of productivity in so many fields, and in origami, is letting dead people do your work for you. Because what you can do is take your problem and turn it into a problem that someone else has solved and use their solutions.”¹ How does this relate to digital transformation in manufacturing?

Fortunately, we don't have to exhume any bodies to find readily available solutions. Efficient manufacturers must do quite the opposite to reduce human error in manufacturing.

Current Contract Manufacturing Software Trends

Contract manufacturing is designed to be more variable, faster, and cheaper than in-house production. As the market shifts in favor of small batches, single batches, and personalized medicines, CMOs and CDMOs are becoming the go-to source to meet the need for flexible production capabilities. This is creating a level of demand for contract manufacturing that has already outpaced current production capabilities.²

Although some manufacturers can utilize traditional manufacturing execution systems (MES) to meet the demand, most manufacturers feel constrained to base their manufacturing processes on one of the oldest technologies available: paper. However, any CMO or CDMO that hopes to keep pace with current industry trends must utilize a more complete approach to digital transformation in manufacturing. Spreadsheets will no longer do.³

MasterControl's recent “The State of Digital Maturity in Pharma and Medtech Manufacturing” report that surveyed 152 life sciences manufacturing professionals found that 65% of them are striving to increase digitization and 63% credit competitive advantage as the reason for doing so.⁴

Clinging to Old Processes

Traditional manufacturing execution systems and paper-based processes yield surprisingly similar manufacturing limitations, including:

• Static, rigid, and likely physical infrastructure.
• Difficult to scale across production lines.
• Disconnected enterprise systems and siloed data.
• Limited real-time responsiveness to quality events.

Embracing Digital Transformation in Manufacturing

The shop floor is a dynamic, often time-sensitive, environment organized around moving parts and shifting schedules. The production environments of contract manufacturers need to reflect an even higher level of variability that in-house production environments cannot.⁵

Contract manufacturers need to be flexible enough to add specialized services and custom solutions and improve the efficiency of their operation in order to attract and maintain their biopharma and medical device company partnerships.⁶

Pursuing digital transformation in manufacturing with contract manufacturing software offers advantages that better serve CMOs and CDMOs, including:

• Electronic production records.
• Real-time visibility and proactive action.
• Data-driven intelligence and agility.
• Integration with enterprise technologies.
• Cloud-based connectivity.
• No-code configurability.
• Simplified product recipe/variant creation and management.
• Scalability to meet changing demand.

Simplicity Is Key to Digital Transformation in Manufacturing

To better understand the transformative potential of removing paper from contract manufacturing ecosystems, the science of origami can give us some key insights. According to Lang, you will be limited in scale and scope (or the complexity of your final piece) by your ability to first abstract (or simplify) it. Once you abstract it, then you can design the base necessary for transformation.⁷

Lang goes on to say abstraction can be the most difficult step. However, this is when you get to rely on someone else, or better yet, technology to solve the problem for you. Consequently, the most difficult step of transformation becomes the simplest if you have the right manufacturing execution software tool.

Configurable contract manufacturing software like MasterControl Manufacturing Excellence can take one of the most persistent components of many manufacturing systems - a paper document - and templatize it into a digital production record. From that point forward, you can begin to add customized “layers and textures” (to borrow origami terminology) unique for each manufacturing process or client. All from one uncut square, only folded over and over again.

They say repeating the same process and trying to get a different result is the definition of insanity. But maybe that's just if you're doing it by hand. McKinsey lists “digital and technology enablement that allows automation of highly repetitive processes alongside generation of new insights and data” as one of five pillars of transformational excellence.⁸

Manufacturing Execution Simplified

Not unlike the trends shaping modern approaches to digital transformation in manufacturing, the current frontiers of origami span both large and small applications. By adhering to the laws of origami and utilizing computer-generated algorithms, scientists were able to design, transfer, and unfold the Eyeglass telescope with a 100-meter glass lens 25,000 miles above the earth.⁹ Following the same laws, different scientists were able to develop, with precision, a 12-millimeter foil heart stent to solve health, efficiency, and cost issues.¹⁰

Myriad models can be developed from a single sheet of paper, but it turns out that paper isn't even necessary.

A similar transformational mindset can lead savvy contract manufacturing partners to adopt digital technologies to replace paper-based ones. Doing so with modern manufacturing execution software allows CMOs and CDMOs to flexibly develop and manufacture a variety of products for more clients. Embracing digital transformation in manufacturing will allow them to optimize their own growth potential in a market that is urgently calling for them to do so.

References:

1. "The Math and Magic of Origami,” Robert Lang, Ted Talk, July 31, 2008.
2. "Answering the CDMO shortage: A new paradigm for drug development,” Daniel Dernbach, Drug Discovery and development, April 6, 2021.
3. "Staying Ahead of ICH E6(R3) Good Clinical Practice Guidelines,” Dario Lirio, Quality Digest, May 17, 2022.
4. "The State of Digital Maturity for Pharma and Medtech Manufacturing,” MasterControl, 2023.
5. "CDMOs on the Rise,” Michel Le Bars, Contract Pharma, Jan. 25, 2019.
6. "The 2022 Value Chain: 5 trends that will shape this promising year
7. Supra note 1.
8. "The Pursuit of Excellence in New-Drug Development: Accelerating Biopharmaceutical development While Reducing Costs,” Guarav Agarwal, et al., McKinsey, Nov. 1, 2019.
9. "Eyeglass Telescope,” Robert Lang, www.langorigami.com, Dec. 10, 2015.
10. "Self-Deployable Origami Stent Grafts As a Biomedical Application of Ni-rich TiNi Shape Memory Alloy Foil,” Kaori Kuribayahi, Zhong You, et al., Oxford University, Jan. 30, 2006.