Welcome to the MassDevice.com knowledge library, a complimentary resource designed for medical device professionals. It's a collection of white papers compiled from our network of hundreds of companies in the medical device field. We're constantly adding to our stockpile and plan to grow it over the coming years into an unmatched resource of industry knowledge and expertise.
The most recently added papers can be found below.
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There are many advantages to understanding an ethylene oxide (EO or EtO) sterilization process when considering the different sterilization options. A knowledge of the process may prevent unnecessary product testing or may identify product changes which may be required prior to attempting to sterilize with EO. The following information, although generic in nature, is designed to provide basic information on the ethylene oxide sterilization process.
This overview covers steps and other considerations for the qualification of new medical devices that will be processed with gamma radiation. The order listed is the approximate order in which various steps will be accomplished. However, it should be recognized that there may be considerable overlap between one or more steps.
Agile Methods have recently been acknowledged by the FDA [AAMI TIR45:2012], but how do you leverage a dynamic development method within a traditional (linear) medical device industry process of regulatory review of requirements prior to development?
Over the past two decades practitioners have validated that Agile software development methods support iterative functionality feature builds, turning specifications and design into tests that enforce clarity, thus revealing implied requirements. Plus they’ve demonstrated that traceability and quality is essentially embedded within the process, as compliance documentation can be continually revised and updated as the system evolves.
In this white paper, RBC Medical Innovations explores if Agile Methods may be the continuous innovation solution that today’s medical device companies seek.
The need to generate high quality clinical data to support medical device labeling claims has increased significantly over the last five years. This, coupled with an increasing requirement to provide substantial clinical data in the post-market setting in both US and Europe, has forced Medical Device and Diagnostic Companies to re-evaluate their approach to clinical development.
The MassDevice Big 100 details the world's 100 largest medical device players, ranked by 2011 revenues.
The deluxe book features:
The last ten years have seen dramatic changes in the landscape of medical devices. From advanced resorbable biomaterials to patient-specific implants, devices are becoming increasingly complex. As a consequence, the cost of device development and the burden of proof for safety and efficacy claims have risen dramatically.
Fueled by innovative clinical applications, imaging technologies are perpetually pushing the envelope of speed and resolution. Today it is virtually impossible to find a healthcare facility without some form of CT and/or MRI system. Furthermore, preclinical image acquisition corollaries (i.e. micro-CT, micro-MR, etc.) that were once available to only the most prestigious research institutions are now available to the commercial device market.
The MassDevice Big 100 details the world's 100 largest medical device players, ranked by 2010 revenues.
The book features:
At only $99, this might be one of the best deals in med-tech today.
In today’s dynamic environment, there is a need like never before for clinical data. In addition to IDE’s, companies are finding themselves doing clinical studies for 510(k) products as well as market approved products. Once the protocol is written and the sites are being selected, the next big task is developing a site budget that is comprehensive and defensible. This can be an overwhelming task, especially if you are a not an accountant and are uncomfortable with developing budgets. This paper will provide an overview of clinical study site budgets, describe the importance of creating a defensible study budget, provide a process for building a site budget and discuss tips for negotiating the budget.
It used to be Sales (field/inside), distributors, business development, or licensing partners were responsible for selling and cultivating business relationships. Marketing would generate awareness and nurture leads among the target audience. Customer service took care of customer problems and answering customer questions post sales. Professional services implemented customer chosen solutions. Customer advocates dealt with supporting customer goals. Customers would buy and use a company product or service. Product development’s job was developing products. While this has not changed, uniting and validating each department’s customer knowledge is key to successfully and effectively fulfilling customer needs.
In Q1 2011, MedPanel, LLC hosted an online survey of sixty-two orthopedic surgeons from practices across the country, divulging industry perspectives on the most innovative hip and knee implant manufacturers. This is the first of an ongoing series with orthopedic surgeons, who are uniquely positioned as end-users to judge innovation.
This document is a collection of articles relating to the mechanical testing of adhesives, textiles, and needles used in medical applications. This document is intended to help you understand the basic procedures and equipment required to tests these devices. When you are ready to test your products or materials to specific standards, we recommend purchasing and referencing official ASTM or ISO publications.
Bausch + Lomb Case Study: Cataract surgery is the most common surgery in America today. Modern surgeries require the opacified crystalline lens to be removed and for a prosthetic lens to be inserted through a suture-less incision during a 5-10 minute outpatient procedure. The industry is driving for smaller incisions by redesigning the lens and insertion device geometry in addition to new materials.
The superelastic, shape memory, biocompatibility and fatigue properties of Nitinol, have made the material attractive for cardiovascular stents. However, it's a complex material and difficult to process. Finite element modeling of Nitinol devices such as stents reduces testing and time-to-market by allowing the designer to simulate the stent manufacturing and deployment processes. The constitutive models for superelastic alloys are available as user subroutine libraries for both Abaqus/Standard and Abaqus/Explicit.
Human Factors Engineering (HFE), also known as usability engineering or ergonomics, is the study of how humans interact with machines and complex systems. As medical devices are becoming more complex human factors considerations are becoming more complex, this paper looks at some of the critical factors in helping medical device companies reduce human error in designing medical equipment.
The Medical Device Plug-and-Play (MD PnP) Interoperability program at CIMIT / Massachusetts General Hospital has been leading the clinical pull for adoption of medical device interoperability for more than five years. We are a multi-institutional, interdisciplinary collaborative program of stakeholders (including medical device companies and regulatory agencies as well as healthcare delivery organizations) who want to see open standards and technology for interoperability developed and adopted, based on clinical requirements.
Learn how to measure your company’s innovation prowess against your competitors. Understanding your company’s innovation rate and corporate "Innovation Quotient" can help you make the tough choices today and create long-term business value. Contact us for more information