What to Look for When Choosing a Medical Device Contract Manufacturer

Two professionals brainstorming with laptopsWhen companies, developers, and inventors seek contract manufacturing services for their medical devices, selecting the right medical service OEM (Original Equipment Manufacturer) is vital for the overall success of their new product. With all the levels of complexities, shapes, sizes, demands, and varying technologies for medical devices on today’s market, the medical device contract manufacturing services company is in a prime position to fill an ever-expanding niche in the medical device manufacturing sector. The strict regulatory environment combined with rigorous international standards, place a high demand for companies that can provide regulatory expertise and fulfill a project from product design and development to testing, validation and verification, manufacturing, and delivery to the marketplace.

A medical device contract manufacturing company is a comprehensive medical device manufacturer that supplies a range of services which covers the entire lifecycle of a product. Clients or companies may need some or all of these services for their product. Nevertheless, medical device OEMs bring to any project a wealth of experience, insight, management, and expertise in a variety of fields that can ensure the success of your product on the market, and do so cost-effectively. Teams of engineers, designers, and regulatory experts work with clients from the design of a new product at its inception to development, validation, and verification, medical device manufacturing, and assembly, final packaging to supply chain management. Depending on the needs of your medical device, medical contract OEM’s will have tooling and machining, or medical injection molding available for the manufacturing of the device.

Saving Time and Money without Sacrificing Quality

One of the main services provided by medical device OEMs is overall cost-effectiveness and time and money saved for their clients. Integrated, cross-disciplinary project teams are in place to make sure the process of design, development, compliance, and manufacturing and consumer markets is streamlined. For example, by working together, design and manufacturing teams effectively standardize procedures and proactively identify, communicate, anticipate, and solve problems. Experienced design engineers monitor trends in emerging technologies, and have a comprehensive understanding of the FDA regulatory and submission process from start-up through performance and validation. Experienced manufacturing teams will likewise meet regulatory requirements in a high volume production environment. They have the capability to produce higher-quality products to meet end-user satisfaction and safety. In total, integrated medical device OEMs are designed to save both time and money.

Following Industry Standards Ensure Success

Managing the manufacturing processes of a medical device or component requires legal expertise, knowledge of the FDA regulatory environment and a robust compliance program to ensure your product’s timely delivery and success. This is another important service provided by a medical device OEM. Inventors, start-up companies, or novices should not underestimate FDA regulations and compliance to them. Class I, II, and III medical devices have different compliance protocols. Choosing the medical device OEM service company will depend on your product’s FDA medical device classification. Some may only handle Class I, II, or III medical device manufacturing. In that regard, knowing what classification your device is and choosing an OEM that exclusively handles that classification can bring a greater degree of experience and expertise to the project.

Identifying Medical Device Contract Manufacturing Expertise

That expertise is needed. The process of regulatory compliance is all-encompassing. Thorough patent research must be conducted. The study of competitive patents or finding patent opportunities for any device is an essential first step. Medical device OEM’s can then seamlessly prepare for FDA inspections, meticulous recordkeeping, audits, and have quality control protocols in place. The medical manufacturer’s responsibility is to be up to speed on current FDA regulations as they relate and pertain to a particular device or product. Compliance with regulatory and quality control, and accompanying legal expertise, are an absolute must that will span the entire lifecycle of the product.

A Partner From Design to Market

From inception to launch, a medical device contract manufacturing services company can provide clients with insight and opportunities for the success of their product. Engineering and manufacturing teams bring decades of combined experience and expertise for their clients. Capable of managing production and consulting throughout the entire process allows all parties to address opportunities for improvements when or if they present themselves. Such contributions can meet the toughest development challenges of your medical device from administering regulatory compliance issues to preapproved materials and processes in manufacturing. In the end, it all adds up to savings and successful delivery of your product to market.