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.
Teleflex Medical OEM, in conjunction with researchers at the University of Connecticut, has developed a tough, high-modulus composite with potential for bone fixation. Fabricated from a unidirectional, fibrous PLLA/apatite, the composite exhibits excellent mechanical properties which correlate to those of natural bone while featuring excellent surface bioactivity. The entire composite is bioabsorbable whereby a device made from the composite will gradually be replaced by natural bone tissue at the implantation site. Early studies indicate integration can occur firmly and permanently with the surrounding tissue. In addition, such prepared composites may have the potential to be used to control the release of growth factors to enhance bone cell stimulation.
Inside MDT’s supplement “Medical Molding”: Read about reaching out to all parties involved in the molding supply chain from Styron; using a polycarbonate plastic in an OTC sinus therapy device from Bayer material Science LLC; basic fundamentals of injection molding process from Promold Plastics; securing low volume run of components for testing from Healthsense; and more about the field of medical molding.
A variety of linear motion devices are available today for performing the function of single-axis movement, whether it be for an assembly operation, testing, packaging or simple motion control. This white paper will seek to define the various types and define the options to be considered when deciding whether to build or buy a single-axis actuator, also known as a linear guide, slide or table in the parlance of particular industries.
Medical device manufacturers have long marketed their products with limited concern for costs. But today, an aging population and skyrocketing medical costs are prompting private insurers and government payers worldwide to limit reimbursements for medical devices. Medical device manufacturers are responding in two ways, by: * Justifying product price points by carefully documenting their value in improving patient outcomes. * Reducing costs throughout their operations by rethinking how they sell and market their products, outsourcing operations, and implementing lean manufacturing principles. Download this white paper by clicking on the link below and learn how enterprise software enables medical device manufacturers to more successfully implement these price justifications and cost cutting initiatives.
Inside:Read about the challenges and solutions for wearable medical devices in “Designing Cutting-Edge Wearable Medical Devices,” from Microchip’s Medical Products Group. Shared are professionals’ opinions on wireless medicine, contract, and manufacturing. Additionally, read about testing, extrusion, sensors, and welding. Check out the selection of products, as well as the offerings for engineers in Design notes.
Inside MDT’s 2011/2012 Buyers’ Guide find a manufacturer and product directory, with a product index. Categories include: component fabrication; design/manufacturing services; electronic components; facility equipment/software; fluid/air transfer; hardware; materials; packaging/sterilization; and testing.
Aftermarket or refurbished battery packs are available for most portable devices. This white paper presents the results of several product teardowns on aftermarket battery packs, both commercial and medical, and explains how substandard aftermarket packs can cut corners on cost, safety mechanisms, and battery performance. These teardowns expose electronic & mechanical design issues, as well as poor manufacturing practices and regulatory violations.
Inside: Read about microelectronics packaging technology evolution accommodating to increasing demands for lightweight and smaller size modules in “Innovative Microelectronics Packaging for In-Vitro Implantable Devices,” from Crane Aerospace & Electronics. Shared are professionals’ opinions on device designs, molding, and cardiovascular. Additionally, read about quiet DC motors, GE healthcare scan, strategic outsourcing, and optimizing power.
In this paper, you will learn what international challenges manufacturers face and how they can best respond to them without affecting production and delivery. The best labeling practices for international markets includes plans for adapting to diverse and evolving regulatory requirements; meeting localization standards; optimizing translation processes; and managing label real estate challenges.
Inside MDT’s Supplement Focus on Ireland: Read about Ireland’s innovation and growth, inward investments, MedinIreland 2011 Expo, the IMDA membership organization, and research capabilities.
Inside: Shared are professionals’ opinions on medical electronics, including: emergence in non-traditional areas, impact of miniaturization, and power concerns, in “Industry Leaders Weigh in on Medical Electronics,” as well as opinions on validation audits and orthopedics. Additionally, read about multilumen extrusions, power, plastics, cardiovascular, and miniature pumps. Check out the selection of products, as well as the offerings for engineers in Design notes.