Corona, Calif. — Requirements for medical molders are changing, with suppliers taking on more responsibility.
At the same time, new technology and automation are changing what is possible to do on the shop floor in multiple industries.
To provide an overview of outsourcing, consolidation and market complexities, Engel Holding GmbH hosted a U.S. regional symposium at its recently-upgraded Corona technical center. Engel is based in Schwertberg, Austria, with U.S. operations based in York, Pa.
The first day of the March 8-9 event focused on the medical market, with packaging in the spotlight on the second day.
Robert Schwenker of Saint-Gobain Performance Materials Corp. talked about how medical device companies pursue strategies to outsource their quality and regulatory risks to suppliers.
The new ISO 13485:2016 standard “explicitly requires an organization to comply with all regulations by 2019,” said Schwenker, business manager for medical components in Austin, Texas, with the corporation's fluid systems business.
He discussed increase in warning letters — and unscheduled inspections — by the U.S. Food and Drug Administration.
Schwenker tracked the increased regulatory oversight from 2002's first-article inspections to 2017's validation programs for equipment, facilities and defined projects.
Schwenker said: “Saint-Gobain wants to anticipate what regulatory systems are saying” as evolving requirements impact more medical device subcontractors and components providers.
In October, Saint-Gobain completed extensive renovation of a Gaithersburg, Md., facility to design, develop and make disposable single-use systems for the cell therapy market.
The performance plastics business is a unit of Paris-area-based Saint-Gobain SA.
Mergers and acquisitions executive Perry De Fazio reviewed recent health care industry consolidations that he said create “a highly advantageous environment for contract manufacturers.”
De Fazio is vice president of private equity firm Covington Associates LLC in Boston and previously spent 15 years as an engineer in medical device research and development.
Market drivers are bringing more value to Tier 1 and Tier 2 contract manufacturers, borrowing terms more commonly used in the automotive industry's supply chain. In many cases, De Fazio noted, the change is beginning to confine traditional health care OEMs to the sales and distribution functions for their products.
An Italian maker of automation equipment and turnkey solutions perceives a demand for high flexibility in the European market and faster redesign of products.
“The solutions are becoming more complex,” said Marco Marconi, sales area manager with Campetella Robotic Center srl in Montecassiano, Italy. “The time-to-market factor is really important.”
Marconi stressed the importance of bringing all functions together at the start of a project. Players include the injection molding machine manufacturer, mold maker, label producer, in-mold-label processor and packaging machinery firm.
Marconi said Campetella will get a new factory of about 91,000 square feet. The business employs 94 and, during 2016, installed 350 robots with 20 percent of the deliveries in Italy and the remainder elsewhere.