This paper explains what IEC 62304 compliance means for manufacturers. It also describes the larger context of systems and software engineering best practices at work in many of today’s most successful companies.
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.
Significant changes are happening to European environmental regulations. While there has been a great deal of discussion and debate over the past few years, in June 2011 the European Union issued Directive 2011 65 EU on the restriction of the
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.
Wireless technologies are bringing about dramatic improvements in the quality of healthcare by allowing patients unprecedented mobility while providing healthcare professionals with easy and real-time access to patient data. Awareness of telehealth and wireless medical applications is increasing with more high profile companies (GE, Google, HP, IBM, Intel, Microsoft, Philips, Qualcomm, Siemens, TI, Walmart, etc,) entering the space, along with prominent media coverage and a rise in the number of conferences highlighting the technology. A recent national study by Philips showed compelling and tangible benefits with telehealth. medicare now reimburses for telehealth under particular circumstances and some private payers in certain geographies are also paying providers to use telehealth. This whitepaper provides a review of the state-of-the-art in tele-machine and wireless medical devices including the key drivers, important developments in end-to-end health and wellness solutions, the opportunity ahead of us, and key challenges for wireless medical device deployments.
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.
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.
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.
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.