• Healthcare   |  Manufacturing   |  Compliance   |  Data Collection
  • Medical Device Manufacturers Use Mobile Data Collection to Stay Compliant

    Written by Robert Brice
    Fri, Aug 28, 2015

    Designing medical equipment creates a lot of data on quality.
    Designing medical equipment creates a lot of data on quality.

    Medical device manufacturers create products designed to save lives. This industry is highly regulated to ensure that devices produced by companies in the industry perform as advertised.

    As many companies move to big data solutions to stay competitive, medical device manufacturers are employing automated data collection technology to provide optimum quality for a very important field.

    The Future of the Industry

    Medical device manufacturers are constantly using new technology on the production floor. Many experts agree automation and robotics will become standard in productions lines. Certain companies focus on collecting data from their new innovations.

    Mazak, a company that makes machines for manufacturers, plans to display a variety of data-driven robotic solutions at a fall open house, Today's Medical Developments reported. As the company prepares for its Discovery 2015 event, Mazak focuses on equipment offering problem-free operation and integrated performance with software solutions.

    The company utilizes a specifically designed technology platform, which facilitates improved performance from five-axis and contouring operations. At the event, Mazak wants to showcase how the new equipment works in conjunction with lights-out automated services and data collection software. Data-driven manufacturing uses real-time information to increase productivity and monitor quality. 

    The Data of Product Quality

    Medical products manufactured through data-driven solutions are of the top quality thanks to constant reporting. Plastics Today detailed how many checkpoints a product like an elastomer medical gasket has to go through in manufacturing and testing.

    Elastomer medical gaskets work in conjunction with injection and infusion equipment. A properly performing product secures the integrity of the medication introduced to the patient. Since the gasket comes into direct contact with medication, government regulators hold it to the highest standards to make sure no foreign contaminants are introduced into a person's body.

    Manufacturers sterilize every piece that goes into elastomer medical gasket assembly. The product is usually constructed from rubber, silicone or thermoplastic elastomers. Rubber doesn't require clean room conditions for manufacturing - although it does need a clean room setting for washing. Silicone and thermoplastic elastomers, however, must have clean room quality facilities from molding to final testing.

    Once completed, manufacturers test product performance and cleanliness. An elastomer medical gasket must have a tight seal. Medical professionals prefer a gasket facilitating constant plunger friction and low breakaway force for precise dosing. Manufacturers also use a test to check for any contaminants introduced during the productions process.

    Mobile Software for FDA Regulations

    The quality of the elastomer medical gasket is evaluated during its entire production life cycle. Starting with initial assembly, to transportation and storage and ending in the user's hands, automated data collection is essential for quality test reporting. Manufacturers use data collection devices that are convenient and able to update progress from every step in the supply chain. The information must be available to all company stakeholders and to government regulators.

    An RFgen Software customer case study examined how a medical reprocessor, Ascent Healthcare Solutions, used mobile solutions to stay FDA compliant. Working with RFgen, Ascent implemented a wireless handheld barcoding system. The software solution was adopted for inventory management. Employees utilized the barcode scanners to collect data from products as they were received, stored and shipped. RFgen assisted with implementation and helped design a system that worked with previous operations. 

    Whether working with robotic manufacturing equipment or in clean room conditions, a unified mobile data collection system is essential for product integrity. A medical manufacturer must choose an ERP system flexible enough to accommodate their particular production and delivery needs. Any company that manages products designed for medical use needs to acquire supply chain management technology that accommodates quality visibility.


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