Inside: “Pinch It: Contamination-Free Fluid Management Using Pinch Valves” Read about transferring fluids in healthcare applications with no contamination from outside surfaces via a pinching mechanism from Bimba Manufacturing. Also, extrusion by balloon tubing can be found inside, as well as self-lubricated polyisoprene. Shared are professional’s opinions on battling HAIs and orthopedics. In addition, check out the selection of products.
Inside: Read about medical device coatings in “Hydrophilic Environments may Promote Easier Device Delivery,” about hydrophilic coatings on device delivery from DSM Biomedical; and “Practical Challenges for Medical Device Coatings” about sterilization methods, shelf life, and aging impacts on coatings from Biocoat Inc. Shared are professionals’ opinions on design challenges, diagnostics, and testing and inspection.
MDT and ECN present the 2012 Medical Electronics Resource Guide. Inside: Find a list of products with contact information for numerous companies. Categories include: boards and modules; electromechanical and mechanical devices; integrated circuits; optoelectronics and displays; packaging and interconnects; passive and discrete components; power sources; sensors; test and measurement; and wireless system components.
Inside: Read about laser micromachining in “Laser Micromachining for Manufacturing of Medical Implants,” about the advancement of medical implants, minimally invasive procedures, and biocompatible materials due to laser micromachining technology from Resonetics LLC. Shared are professionals’ opinions on prototyping, materials, and portable medical.
Download this whitepaper on choosing an embedded OS for medical devices where reliability, recovery and safety are critical differentiators. It provides a high-level list of requirements that device manufacturers can use to evaluate OSs considerations.
Inside:Read about handling many tasks in the product development process in “An Outside Perspective: Joining Forces to Bring New Technology to Market,” from Stratos Product Development. Shared are professionals’ opinions on miniaturization, implantable devices, and machining. Additionally, read about motion control, connectors, pumps, and test, measurement, and sensing.
Diagnostic Grifols, a leading medical device provider, is implementing a solution to enhance collaboration throughout its product development cycle, sees significant results in time to market and regulation compliance.
The challenges faced by medical device manufacturers can no longer be solved by examining problems individually. IBM Rational solution for medical devices provides a comprehensive and holistic answer that makes it easier to comply with regulatory mandates, while at the same time improving the efficiency and effectiveness of the product development team.
Inside: Read about silicone for component fabrication in “Challenges and Rewards of Molding Silicone,” from Nolato MediTech. Shared are professionals’ opinions on balancing development success and medical electronics. Additionally, read about batteries and holders, power, anodized device delivery, tubing, orthopedic implants, and antimicrobials. Check out the selection of products, as well as the offerings for engineers in Design notes.
Inside: Read about making connections easy and safe with single-use tubing connectors in “Making the Change: in Single-Use Tube Connections,” from Value Plastics. Shared are professionals’ opinions on home healthcare, medical packaging, and ER/Surgical. Additionally, read about design, packaging and interconnects, biomedical textiles, and medical molding. Check out the selection of products, as well as the offerings for engineers in Design notes.
There are substantial changes in the 3rd Edition of IEC 60601-1, and understanding all aspects of these changes is the key to turning this new standard into a benefit for you as a medical device manufacturer. This paper is designed to explain the philosophy behind the the major changes in the standard, explain how these changes will affect device manufacturers, and share information as to which resources are available to help make the smoothest possible transition to the new Standard.
Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits, and ChallengesAugust 1, 2011 7:15 am | by Igor Veljanovski White Papers
The medical devices industry, as well as the pharmaceutical industry, is slowly but indisputably accepting the concept of Quality by Design into its design and development product phases, and is introducing the statistical tools and methods of the concept into its process verification and validation phases as well. The Quality by Design concept or approach has found its implementation in the medical devices life cycle management, under the guidance of risk regulations by the International Conference on Harmonization. Since the importance of successful implementation of this concept is ever more evident in industry, this white paper will therefore discuss the concept and its possible implementation in the medical devices industry, along with the benefits and concerns expressed by the manufacturers.
It is widely known and published that modern sterilization techniques used in the healthcare industry can have a detrimental effect on thermoplastic polymers. In particular, gamma sterilization, which is the most common ionization method, can cause substantial changes to occur in polymeric materials. Polymer chain scission and cross linking can both occur, altering the physical properties and appearance of materials and ultimately affecting the functionality of a device utilizing these materials. RTP Company’s TPE (Thermoplastic Elastomer) Division has initiated a series of projects to measure the effect different sterilization methods have on RTP Company’s standard TPE products used in medical devices. This paper discusses the effect gamma sterilization has on these various TPE compounds produced by RTP Company for the healthcare industry.
Different types of screw threads have evolved for fastening, and hydraulic systems. Of special concern are plastic-to-metal, taper/parallel threaded joints in hydraulic circuits. A discussion and recommendations are provided to create an awareness of different types of threads and how they are used.
Calibration, maintenance, and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected systems made sense. However with new regulatory pressures and in search of greater productivity and efficiency, leaders in the life science industries have explored and experimented with different ways to harmonize these systems. Until recently, the available options have required significant compromises to be made. This paper discusses the evolution of the driving forces and the available solutions for harmonizing calibration, maintenance and validation, concluding with the latest technologies designed to eliminate the need for the departmental compromises previously required to achieve harmonization.