Using stock components could allow designers to focus on product innovation while relying on supplier investments in tooling, efficiency, and regulatory compliance.
Medical device designers are constantly trying to be innovative. New ideas will lead to new product launches, new therapies, new markets, new customers.
But to innovate, do designers need to start from scratch with every component?
Maybe not. Stock components allow designers to explore a wide range of samples and materials while benefiting from supplier investments in tooling, efficiency, and regulatory compliance.
The following 6 potential outcomes to using stock components could help designers focus on innovation:
1. Free up time and budget to focus on developing products, not parts. "Before companies started offering stock components, product designers needed to design the various components they would use in addition to the core product," Scott Herskovitz, Qosina's vice president, sales and marketing, told Qmed. "Tooling would have to be created and the components manufactured. Not only does tooling cost thousands of dollars, but tooling for the components may only need to be run for one day to get the entire yearly need of the production process."
Stock component providers like Qosina "aggregate the usage of these components across many customers, which minimizes the investment needed by any one firm," he explained. "Companies purchase from Qosina to eliminate the cost of tooling their own components and to receive immediate delivery from inventory."
|Tuohy borst adapters|
2. Experiment with more options, in less time. Designers can also try out different stock components during the product design phase. "Qosina provides complimentary samples on most products so they can be tested during prototyping and research and development, which reduces time to market," Herskovitz said. "We have over 5,000 SKUs in stock in our warehouse, and we can supply our R&D customers with one piece for review, 100 pieces for sampling and prototyping, and thousands to millions of pieces for a production line." With thousands of stock components to choose from connectors to mating caps to tubing, designers have "more options for being innovative and iterative in designing the best solution," he adds.
In addition, "designers can utilize Qosina as their one-stop-shop for components without having the hassle of using several different sources for one project, therefore, easily streamlining their vendor lists."
3. Benefit from "crowdsourcing." Customer ideas sometimes turn into stock components. "We listen to their concerns or suggestions and follow industry trends," he said. "In addition to developing new products internally, our product development team also works with customers to modify existing components or produce something completely new to their exact specifications. If the project is not proprietary, we may add the custom product to our catalog as a stock item."
End-user needs also prompt inventory additions. Qosina is a member of the Global Enteral Device Supplier Association(GEDSA), whose mission is to promote initiatives surrounding safe and optimal delivery of enteral feeding and connectivity, said Herskovitz. "In an effort to improve patient safety, Qosina added a number of ENFit products to its inventory," he said, explaining that ENFit is a line of enteral feeding connectors that meet the ISO 80369-3 standard, which has been developed by the International Organization for Standardization to reduce the risk of small-bore misconnections used in liquid and gas healthcare applications. "Qosina continues to expand its ENFit line to meet the needs of clients' enteral projects and can modify any existing component or build new tooling to suit exact requirements."
|The ENFit line of products|
Qosina also is a member of Bio-Process Systems Alliance (BPSA), an organization that encourages the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. Qosina continues to add new bioprocessing components based on industry trends, Herskovitz said.
4. Get scientific support. Material alternatives can also be explored through stock component suppliers' efforts. "Phthalates and plasticizers such as DEHP, BPA, latex, and substances of animal origin used in raw materials can generate concerns of material compatibility and leaching," Herskovitz said. "Qosina offers a number of DEHP-free, BPA-free, latex-free, and animal-free products. We support our customers' questions and concerns with full documentation, such as safety data sheets, technical data sheets, and compatibility information to ensure our customers are qualifying the appropriate material for their projects."
Designers are provided with detailed component drawings and material specifications that allow them to easily implement components into their design as well as comply with government regulations, he added.
5. Become more efficient. Designers can benefit from suppliers' ongoing efforts to achieve efficiency in inventory and fulfillment. "Qosina receives hundreds of requests daily for samples of its products. To meet these demands, we purchased a vertical lift module (VLM), which is an enclosed storage system with the same amount of parts and inventory as traditional bin storage methods, but requiring significantly less floor space," he said. "Our VLM, which holds an estimated 10,000 components, contains vertically arranged trays, and computerized controls deliver the trays with the stored parts to a work counter so the operator can pick the part. Since acquiring the VLM, our order preparation process is more productive and efficient, and response to customers is quicker."
|Tubing from Qosina|
6. Get assistance with regulatory compliance. Qosina obtained the ISO 13485 certification, a globally recognized standard that specifies the requirements for a quality management system that can be used by organizations providing medical devices, components, and delivery of related services. "This certification gives our customers greater confidence in our ability to meet their commitment to quality, safety, and compliance," Herskovitz said. "Qosina is also ISO 9001 and ISO 14001 certified and is committed to maintaining and continually improving its quality and environmental systems."
The company is also planning expansions of its cleanroom facilities. "Qosina has a special ISO 14644-1 certified Class 8 cleanroom (formerly Class 100,000) assembly area that is available for product repackaging upon request," he said. "This year we plan to construct a larger cleanroom that will allow us to be more efficient in ensuring that products manufactured in a cleanroom are not compromised for sampling or repackaging."
To see some of Qosina's stock components, be sure to visit Qosina at Booth #1529 at the upcoming Medical Design & Manufacturing East Expo in New York City June 13-15.
[All images courtesy Qosina]