EAGLEVILLE, Pa.--Medical product manufacturers today are looking for suppliers that can take their concept and go all the way to commercialized product. One supplier that appears to fit this description is Inteprod LLC, an Eagleville, Pa., company that was recently named Manufacturer of the Year by the Greater Philadelphia Chamber of Commerce. According to Inteprod's marketing and communications spokesperson, Lori K. Pegon, the company is a “full-service, total solutions partner” that provides innovative design, development, and contract manufacturing and assembly services to medical OEMs and emerging startups in the medical device and diagnostics and food safety industries
Inteprod can take an OEM's project and “do everything the OEM used to do themselves, and provide it more quickly and cost-effectively,” according to Ms. Pegon. Inteprod's team has 26-plus years of experience in the medical device and diagnostics industries. This experience is a huge asset that sets them apart from other companies, she says.
“We do it all here, and everything we do is designed and developed for complete manufacturability with strict adherence to quality and regulatory standards,” says Ms. Pegon. “Our ability to design, develop, and manufacture in-house contributes to reduced costs and time-to-market, and, ultimately, to the overall success of the product.” Even when Inteprod doesn't do the manufacturing for a particular project, Ms. Pegon says, its clients know that when the design or prototype is completed, they will have all the documentation they need to manufacture and commercialize their product.
“Many of our clients come to us because they had problems with the original design company they hired,” says Ms. Pegon. “Many design companies follow the specifications and deliver a product that meets those specifications, but it was not designed for manufacturing and serviceability, and may not have any documentation. At Inteprod, our designers not only design to the client's specifications from the beginning, they are designing for manufacturability (DFM) and serviceability, and always creating and updating the Design History File (DHF). In the end, the customer will have a product and the documentation to pass their 510(k), and go straight into manufacturing--not to another set of designers for redesign for manufacturing.
Another area in which the company differentiates itself is its “deep knowledge of and adherence to quality assurance and regulatory compliance,” according to Ms. Pegon. Many design companies that don't specialize in the medical industry don't know all that's involved in the documentation required for medical products, as well as the regulations. Without this knowledge, the customer may not receive a documentation package that will pass a 510(k) approval process. “In medical design, you've got to know what you're doing,” she emphasizes. The documentation is extensive and includes the DHF, test and validation protocols, and safety agency testing. Inteprod provides complete documentation for all products, and the documentation is available to the client for their complete review and approval via an FTP site.
Inteprod can work with OEMs at one or more stages of product development, from concept design, feasibility, and product design, to in-house rapid prototyping, validation, safety agency approvals, and manufacturing. The firm's engineers use SolidWorks for designing and refining medical components and products in a 3-D virtual environment, allowing for easier design changes and reduced production time and costs. The company employs sophisticated computer modeling capabilities to help reduce development time by reducing the number of design iterations needed. Mold flow analysis, 3-D solid modeling, and in-house rapid prototyping play essential roles in cost reduction by allowing Inteprod to analyze and optimize engineered components before releasing tooling. In addition, Cadence® OrCAD® PCB Designer Software, for innovative PCB design, is used for mechanical and electrical integration; and PDM Works, for design revision change control. Exact JobBOSS software manages and tracks day-to-day activities, including purchasing, inventory control, and supplier control.
The company's capabilities are applicable to the development and manufacturing of medical device and diagnostic products that include, but are not limited to, patient monitoring solutions, analytical instruments, and minimally invasive surgical devices. Inteprod's design and development portfolio includes an RF ablation device used to treat obstructive sleep apnea; an ultrasonic contact lens cleaner; and an HIV analyzer. The company also provided automation design (including mechanical, software, and electronics) and assembly and validation for a fully-automated product assembly system for diagnostic consumables.
For one client, a major life sciences OEM, Inteprod designed and developed a custom automated process that replaced a manual, repetitive, and complex process. Although the OEM's engineers didn't believe that the process could be automated, Inteprod created a robotic process that replaced the manual procedure and increased productivity, accuracy, and precision within a sterile environment. The result was a drastic reduction in human error, according to Ms. Pegon.
For the HIV analyzer, Inteprod provided product design (industrial, mechanical, software, and electronics), chemistry integration, design of a bead-based microplate, and assembly and validation of the protototype. It also designed a diagnostic analyzer, with consumables, used to detect and quantify contaminants in biopharmaceutical products. Inteprod's contribution included product design; sourcing and management of tooling; prototype assembly; and fluidics design. The company also performed system test and verification.
“Everything we do includes complete documentation,” says Ms. Pegon. “Inteprod complies with ISO 13485:2003, ISO 9001:2000, U.S. Regulation 21 CFR 820, cGMPs, and UL requirements. We follow strict Lean Manufacturing processes, and all products are built to the released performance and process specifications.”
Inteprod's Manufacturer of the Year Award is one of the Greater Philadelphia Chamber of Commerce's 2009 Excellence Awards honoring the Greater Philadelphia region's small businesses.
For more on Inteprod, visit www.inteprod.com.
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