Introducing new medical devices is pivotal in advancing patient care and treatment outcomes in the ever-evolving healthcare landscape. New product introduction (NPI) is a critical phase in developing and launching these devices, demanding precision, expertise, and seamless collaboration among various stakeholders. One key player that significantly contributes to the success of NPI in the medical device industry is the contract manufacturer. In this blog post, we'll explore the importance of NPI and how contract manufacturers can be instrumental in its success.
New product introduction is a comprehensive process that covers designing, developing, testing, regulatory compliance and commercializing a new medical device. It is a phase where innovation meets regulatory compliance, and meticulous planning is crucial to ensure the product's safety, efficacy, and market success. NPI encompasses several key stages, including:
Sanbor Medical and our strategic partners can help in these areas. After completing these initial areas, we specialize in the following stages: scale-up and manufacturing.
Contract manufacturers play a critical role in the NPI process for medical devices, offering specialized services that can significantly enhance efficiency and outcomes. Here are several ways in which contract manufacturers contribute:
Contract manufacturers bring a wealth of experience across the entire product lifecycle. From design and prototyping to manufacturing and post-market support, they possess the technical know-how to guide a medical device from concept to commercialization. This extensive expertise supports every phase of the NPI process and is executed with precision and compliance. Sanbor Medical has more than 30 years of experience and focuses exclusively on the manufacturing of medical devices.
Time is a precious commodity in the world of medical device innovation. Contract manufacturers, including Sanbor Medical, specialize in optimizing processes and minimizing lead times. By leveraging their efficient workflows, they help reduce the time to market for new products, enabling quicker access to cutting-edge medical solutions. Contract manufacturers can often efficiently scale up production without needing significant capital investment from the medical device company, optimizing the company's resources.
Contract manufacturers have the infrastructure and resources necessary to scale production efficiently. As the demand for a new medical device increases, these partners can seamlessly adjust production volumes without compromising quality. This scalability is particularly important in meeting market demands and responding to unforeseen circumstances. Most medical devices are manufactured in low to medium-sized volumes. Sanbor Medical's manufacturing operation is supported by a low volume global supply chain to help you grow from low volume orders to larger batches. While many contract manufacturers prefer high volume orders with a small number of parts, we also welcome small and medium volumes.
Developing and manufacturing medical devices often involves significant capital investment. Sanbor Medical’s global manufacturing footprint allows us to provide competitive services and pricing through global sourcing and consolidated purchasing power. We maximize your device manufacturing budget by saving on labor, materials, and manufacturing overhead costs — all without sacrificing the quality your customers expect. This enables innovators to bring their products to market without the burden of establishing and maintaining extensive manufacturing facilities.
The dynamic nature of the medical device landscape requires a high degree of flexibility. Contract manufacturers excel in adapting to changes in project scope, design modifications, or unexpected challenges. Their ability to pivot quickly ensures that the NPI process remains on track, even in the face of unforeseen obstacles. Sanbor Medical is able to customizes a solution based on your needs, utilizing multiple manufacturing facilities, including the U.S. or a lower cost country.
Medical devices are held to higher quality standards than other products so ensuring quality and consistency is paramount. Contract manufacturers implement robust quality control measures throughout the production process, from materials sourcing to final assembly, to consistently produce reliable output. Your reputation depends on device quality. Sanbor Medical is built around FDA-audited facilities and quality control standards. We have passed FDA audits with zero nonconformities and are rigorously audited by leading top 30 global medical device companies.
The successful introduction of new medical devices is a collaborative effort that requires a harmonious blend of innovation, regulatory compliance, and efficient manufacturing processes. Contract manufacturers are indispensable partners in this journey, providing specialized services that enhance the entire NPI process. Sanbor Medical provides a U.S. Manufacturing Project Manager that will handle all aspects of NPI, from initial review of engineering and design through customer approval of the First Article and Pilot Production runs.
As the healthcare industry continues to advance, the partnership between medical device companies and contract manufacturers will play a crucial role in bringing innovative medical devices to market efficiently, safely, and with the highest level of quality.
Sanbor Medical has the expertise to help you bring your new product to market and overcome the challenges OEMs face in the medical industry. Manufacturing quality medical devices is all we focus on, and we have the credentials to prove it. Connect with a team member to learn more about our complete medical device contract manufacturing services and receive a no-obligation quote today!
