3D printing has proven transformative in industries ranging from automotive to aerospace. But can it do the same in biopharmaceuticals?
Until a few years ago, biopharmaceutical company Merck & Co. felt there were novel solutions involving 3D printing that could apply to many challenges it faced, but the company ignored those solutions due to the time, cost, and complexity of pursuing them externally. That all changed in 2015, when Merck initiated a small pilot project around 3D design and fabrication, validating the value the new capabilities could give the company.
“Over the past four years, Merck has increasingly leveraged advancements in Additive Manufacturing (3D printing) to establish state-of-the art capabilities aimed to enable and drive innovation across our enterprise,” says Michele D’Alessandro, vice president and CIO of manufacturing IT at Merck & Co.
The project, which focused on driving innovation, saving time and costs, and protecting intellectual property, is part of a digital strategy involving computer-assisted design (CAD) for digital manufacturing, simulation, extended reality (AR/VR/MR), and future IoT. D’Alessandro says the project is the rare example of the IT infrastructure team taking the lead in bringing innovation to the business.
“We largely relied on the local relationships between the traditional managed print/local computer infrastructure staff and the business users — co-located with them — for the early pilot definition,” D’Alessandro says. “It was really grassroots, starting with the brainchild of someone who was passionate about advancements in print technology and equally passionate about helping our business. The beauty of this project is that the traditional IT infrastructure area, historically less focused on innovative solutions to business problems, drove the grassroots effort. It is truly rewarding to have seen our infrastructure organization rise to the challenge through the project lifecycle.”
From pilot to production
Merck ran its pilot from the second quarter to the fourth quarter of 2015 in a 400 sq. ft. lab with a mandate to explore broader use of 3D printing within Merck. D’Alessandro’s team identified a selection of pilot applications to evaluate the feasibility and value of establishing internal 3D printing capabilities.
The lab explored engineered solutions, 3D CAD models, fabricated prototypes and end use parts to measure the time, cost, and efficiency improvements that could be brought to bear on existing processes. The team compiled a business case based on the outcome of the pilot, which it used to convince senior leader to provide support for a production enterprise service implementation beginning in 2016.
The pilot was the first phase of five in Merck’s project, Enterprise 3D: Where Physical Meets Digital. The project earned Merck a CIO 100 Award in IT Excellence.
“The project was structured into phases focused on evaluating the divisional and regional requirements and demand, then implementing the capabilities in a Center of Excellence for 3D print,” D’Alessandro says.
The second phase, from the first quarter of 2016 to the first quarter of 2017, involved the deployment of a North American production center. Merck established a 10,000 sq. ft. lab in New Jersey, with five of the seven 3D printing technologies implemented in conjunction with associated post-processing and traditional fabrication equipment. This phase also included creation of a custom web portal to provide the business the ability to receive and manage demand. The portal also allows for tracking, prioritization, and reporting on projects, as well as resource allocation in the form of machines, materials, personnel.
From there, Merck deployed a 3D production center to service EMEA. and established a new center in Ireland. It also expanded its North American center to include metal printing, injection molding and CNC capabilities. Later, in 2018, Merck brought 3D printing to a site in Singapore to support expansion in the China, Japan, Asia-Pacific (CJAP) region, and added bio-fabrication capabilities and a state-of-the-art digital design room to its New Jersey facility.
The company has also deployed a strategic product lifecycle/product data management (PLM/PDM) solution to integrate with its web portal, providing enhanced demand workflows and a searchable catalog of parts. The short-term objective of CAD data management was to support 3D technologies project, D’Alessandro says, but there is also a long-term goal of integrating with the PLM platform to support enhanced digital capabilities built off underlying CAD data, as well as extended reality (AR/VR/MR), simulation, analytics and generative design, and IoT.
This year Merck plans to add a second center North American center in Pennsylvania. The focus is to support future expansions in sterile vaccines, biologics, and clinical/commercial manufacturing [GxP] applications, D’Alessandro says.
The multi-year project has resulted in several pleasant surprises and a “rock solid” technical capability limited only by the current state of material science, she adds. The company realized 300 percent ROI from the project in 2016, its first year of operations. On average, the project has helped the company realize 80 percent cost savings and 85 percent time saving, she says. The company has submitted multiple patents as a result of its 3D Technologies organization and several other patents were submitted by the business areas utilizing the 3D print services. The company has also made numerous safety enhancements as a result of the project, D’Alessandro says.
But perhaps the most important result of the project has been realizing that enabling innovation in its most tangible form across the company is what cultural change is all about, she says.
“The specifics of this investment and associated return are likely pretty unique to Merck when considering the scale of enterprise IT footprint and our ability to leverage it for sponsoring this project. While the direct project may not be applicable, what is definitely a great practice and learning out of this is to engage your core infrastructure staff members and empower them to bring innovative ideas to their day-to-day work,” D’Alessandro says.