As in other industries, medical device manufacturers face challenges in developing and commercializing their products quickly and affordably while maintaining compliance with industry regulatory standards. Partnering with outsourced providers often helps OEMs streamline functions from design and engineering to distribution, helping to accelerate time to market, control costs, and push multiple products through the pipeline simultaneously with limited resources.
But with any outsourcing effort, there are both benefits and risks. Outsourced projects and outsourcing relationships can leave companies questioning their partners and even the outsourcing model. Successful outsourced relationships rely on setting clear expectations, selecting providers that fit a company’s needs, and collaborating with partners throughout the program.
The keys to effective outsourcing are careful selection of the manufacturing partner, a detailed plan for the process, and understanding the specific benefits the manufacturing partner can provide and how to maximize them.
Before selecting a partner, develop an understanding of the motivations and expectations for outsourcing. Be specific about what parts of the process to outsource and what outcomes are expected. Establish realistic expectations and identify potential challenges and risks up front. Expecting near-perfect performance or a hands-off relationship can generate conflict throughout a program.
Selecting a partner should focus on requirements and differentiators. Device companies require complete confidence in the ability of its manufacturing partner to meet the highest levels of quality, control, and compliance. Requirements should include Quality Management System (QMS) fundamentals, regulatory certification, and how the partner combines their capabilities with your program needs. Differentiators include capabilities, experience, expertise, communication, and program management methodologies.
Some questions to consider are:
- Does the prospective manufacturing partner have experience with the scope of work you require? Does the provider have the technology and capabilities that fit your particular needs?
- Does the manufacturing partner have experience with the regulatory requirements of your device(s) and market(s)?
- If you market devices in specific countries or regions, does your manufacturing partner offer global reach? Each device class in the U.S., Europe, and Canada carries a different set of requirements – is the potential partner familiar with the necessary regulations?
- How will your organization collaborate with the manufacturing partner? Will there be a schedule of meetings and reviews? Do you require personnel from the partner to be onsite at your location for immediate communications?
Finding the best outsource provider for your company is a time-consuming and challenging task, but ultimately, the goal is to find the best provider for completing the outsourced work while optimizing quality, time, and efficiency, as well as overall return on investment (ROI) relative to program goals.
Medical device manufacturers can optimize the capabilities of an outsource provider by carefully evaluating the potential manufacturing partner; understanding how to collaborate effectively throughout the design, development, and commercialization stages; and defining expectations for overall value.
An outsourced manufacturing partner offers medical device companies advantages that include speed, specialized expertise, diverse experience, flexibility, and global reach that can prove instrumental in optimizing a device manufacturing company’s efficiency and delivering the fastest and largest return on investment.