There are many reasons to partner with a contract manufacturer, perhaps chief among them as a part of a competitive approach to alleviating pain points associated with medical device manufacturing. In-house manufacturing is a costly and time-consuming endeavor. There are significant costs involved, from those related to production equipment to the time and labor costs connected with hiring highly trained staff.
Outsourcing removes the need for these considerable startup costs—not to mention costs associated with the maintenance and calibration of equipment necessary for regulatory and certificatory compliance[1]. It further reduces payroll and other operational overhead costs by relying on an off-site partner's project management, development, and QA and testing staff.
Each medical device is different, and its manufacture requires highly customized processes at virtually every stage of fabrication, testing, and quality assurance. Partnering with an experienced contract manufacturer specialized in medical device manufacturing is an excellent option to minimize associated costs and a lengthy time to market.
It ensures the various specific components unique to each device are developed and tested, and their performance is validated and qualified as efficiently as possible. It also removes the burden of purchasing expensive fabrication hardware and equipment, allowing a streamlined and cost-effective path from research and development phases to upscaling and market production.
Medical device manufacturing can benefit from certain technologies of scale associated with the specialized processes involved. An experienced contract manufacturer will know how to best leverage design elements for optimal efficiency and cost savings.
A contract manufacturer can also deliver products according to an agreed-upon timeline, allowing for staged scale-up or strategic logistical considerations. This minimizes operating costs and enables a client working with a contract manufacturing partner to maintain greater financial liquidity and a more robust financial position.
Outsourcing with an experienced medical device contract manufacturer brings with it the benefit of their expertise in the technology involved. Opportunities for streamlining production methodologies or other cost-saving design and manufacturing options are more accessible through the proficiency of dedicated and specialized medical device manufacturing contractors.
With a partner handling the many various aspects of manufacturing and bringing a product to market, the clients of contract manufacturers further optimize productivity and get the most out of budget expenditures. Letting a production partner focus on minimizing manufacturing costs and meeting deadlines enables a client company to focus their efforts on their core business.
Each medical device is unique and requires highly customized testing technologies[2] and methods. Whether quality assurance is related to or in conjunction with regulatory demands, testing may be required for tensile material strength, resistance to certain substances or chemicals, pressure response or function testing, or testing for package seal and sterile assurance.
Testing and compliance require significant collection and analysis of data that must then be recorded in a specific manner to meet stringent guidelines and regulations. Familiarity with these procedures is essential to enabling rapid market deployment, and both the necessary training and any mistakes due to ignorance can be costly.
Contract manufacturers experienced in medical device manufacturing can offer additional labor and cost savings with expertise specific to this highly specialized documentation. Outsourcing to industry experts with day-to-day knowledge of these intricacies minimizes the time required for this critical step and ensures the highest level of professional knowledge possible.
A qualified and experienced contract manufacturer will be capable of providing full-service solutions to its clients, including support over the life cycle of an individual product and its iterations. From planning for upgrades and product improvements to the eventual sunset and obsolescence phases, the right manufacturing partner will institute policies to ensure top-notch customer support through development, manufacture, distribution, and use.
A contract manufacturer should function as a partner in the device manufacturing process. Due to the industry's demands and highly specialized nature, developers of medical devices seeking the services of a contract manufacturer should carefully consider their options. Know-how and specialization are essential for successful and profitable production and manufacturing processes.
Sanbor Medical has the expertise needed to serve as a valuable partner in manufacturing medical devices. With over thirty years of industry experience—fifteen of them as an exclusive manufacturer of medical devices—Sanbor Medical can deliver the highest quality devices at competitive costs. Contact us today to get a no-obligation quote or discuss your specific needs.
[1] https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
[2] https://www.sanbormedical.com/services/medical-device-testing-programming-validation
