Digital Transformation in Contract Manufacturing Industry Trends

The art and science of origami can give us insight into the transformative potential of removing paper from production ecosystems. 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, in 2019, “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

With a modern MES solution, contract manufacturers can scale up and down with ease to match current market demands, in much the same way that origami scientists have been able to transform the traditional paper crane into the latest origami heart stent or space telescope. Fortunately, we don't have to exhume any bodies to find readily available solutions. Efficient manufacturers must do quite the opposite and dig into the power of digitization to reduce human error in manufacturing.

Current CMO and CDMO 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 have been able to utilize a traditional, legacy MES, most manufacturers continue to base their manufacturing processes on one of the oldest technologies: paper. CMOs and CDMOs that hope to keep pace with current and future manufacturing industry trends must utilize a more complete approach to digitization. Spreadsheets will no longer do. ³

Clinging to Old Processes

Traditional MES and paper-based processes yield surprisingly similar results in terms of limiting manufacturing capabilities, including:

• Static, rigid, and likely physical infrastructure.
• Not designed to easily scale across production lines.
• Disconnected enterprise systems and siloed data.
• Limited real-time responsiveness to quality events.

Embracing Digitization in Manufacturing

CMO and CDMO trends indicate that 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. ⁴

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 Greater investment in digitization is a contract manufacturing industry trend that increases both the value of and demand for contract manufacturing partnerships.

Pursuing digitization in manufacturing with a modern MES solution like Manufacturing Excellence offers advantages that better serve CMOs and CDMOs, including:

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

Simplicity Is Key

According to the science of origami, you will be limited in scale and scope (or the complexity of your final piece) by your ability to first abstract (or simplify) it, and then you can design the base necessary for transformation. ⁶

Lang says this can be the most difficult step. He also points out that 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.

A configurable, modern MES solution 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 the customized layers and textures 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. ⁷

The Transformational Potential of Paperless 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. ⁸ 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. ⁹

A myriad of 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 a modern MES solution allows CMOs and CDMOs to flexibly develop and manufacture a variety of products for more clients, ultimately optimizing their own growth potential in the current market that is urgently calling for them.

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 2022 Value Chain: 5 trends that will shape this promising year,” Carsten Press, Contract Pharma, March 8, 2022.
5. “CDMOs on the Rise,” Michel Le Bars, Contract Pharma, Jan. 25, 2019.
6. Supra Note 1
7. “The Pursuit of Excellence in New-Drug Development: Accelerating Biopharmaceutical development While Reducing Costs,” Guarav Agarwal, et al., McKinsey, Nov. 1, 2019.
8. “Eyeglass Telescope,” Robert Lang, www.langorigami.com, Dec. 10, 2015.
9. “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.