Boris Levin, president, NP Medical Inc., Clinton, MA
Challenges and opportunities abound for an OEM supplier competing in the field of disposables. To leverage its competitive edge, a company must decide how to implement a formal quality system. A major consideration for an OEM in choosing a supplier is the compatibility between the two companies’ quality systems. Manufacturing under a stringent system with high standards, together with specific customer requirements, will help guide a company into choosing the necessary tools for success, such as whether to run in a cleanroom environment.
OEMs will spell out specifications with regard to materials, but suppliers can choose how to maximize profitability within their own manufacturing environment. An example is the increasing trend toward the use of high-speed automation. Its cost advantages allow companies to maximize output and lower labor costs while meeting demand in a timely fashion.
Firm Produces Custom IV Components
A company produces components that can be incorporated into precise medical technologies. Products range from a variety of intravenous (IV) set components to fluid access devices and needle-free disposables. In-line back-check valves and pressure-activated, antisiphon valves are available in multiple styles and materials for use in a variety of fluid-handling applications. Bidirectional luer-activated designs, including needle-free devices, provide a clear visualization of the fluid path. A line of IV filtration products incorporate a high-throughput membrane. All products are manufactured to industry standards in ISO Class 8 and Class 100,000 cleanrooms. Components are assembled using high-speed automation in compliance with ISO 13485.
NP Medical Inc., Clinton, MA
Companies Announce Strategic Alliance to Develop Disposable Medical Devices
A full-service biomedical product development company specializing in high-volume, disposable devices and a rapid prototyping service provider focused on precision stereolithography models will soon open a Technology Development Center. The alliance is meant to further the product development process. The addition of prototypes will eliminate typical iterative tooling costs.
Gilero LLC, Raleigh, NC, and FineLine Prototyping Inc., Raleigh, NC
Valves Can Be Customized
Two spring-loaded micro check valves with flow rates of 0.4 to 1.7 lpm at 5 psi can be customized by selecting from a range of plastic and O-ring materials and cracking pressures from 0.10 to 20 psi. The smallest valve is 3/8 in. long and inserts into 1/8-in.-ID tubing with zero leakage. Another model inserts into a 1/4-in.-ID line with zero leakage and can be ordered in reverse flow. Both valves may be used as pressure relief valves. The firm’s engineers can also develop application-specific custom solutions.
Smart Products Inc., Morgan Hill, CA
Precision Miniature Barbed Luers Are Produced in a Cleanroom
A company offers a line of precision miniature barbed luers. The outside dimension of the barb measures 0.066 in., making it suitable for connecting smaller ID tubes. The products are available in nylon and are manufactured in the company’s cleanroom. Secondary operations such as assembly and packaging are performed within the cleanroom as well. Total project management, including engineering services, tool design and development, and manufacturing for prototype and production runs, are also provided.
Injectech LLC, Loveland, CO