Knowledge Library

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.

To find out how to add your white papers to our growing library, contact us at whitepapers@massdevice.com

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INTRODUCTION TO GAMMA PROCESSING
Steris Isomedix Services

Gamma radiation are high-energy photons are emitted from an isotope source (e.g., Cobalt 60). These photons can create ionization (electron disruptions) throughout a product.

This whitepaper will illustrate the process of using gamma processing in the sterilization of medical devices.

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Anatomy of an Ethylene Oxide Sterilization Process
Steris Isomedix Services

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.

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Product Qualification for Gamma Processing
Steris Isomedix Services

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.

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Is Agile Management a Medical Device Innovation Solution?
RBC Medical Innovations

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.

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AN INNOVATIVE ADAPTIVE MONITORING METHODOLOGY FOR MEDICAL DEVICE & DIAGNOSTIC TRIALS
Aptiv Solutions

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.

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The MassDevice Big 100 - 2012 Deluxe Edition sample
MassDevice.com

The MassDevice Big 100 details the world's 100 largest medical device players, ranked by 2011 revenues.

The deluxe book features:

  • Interviews with 5 top medical device company CEOs
  • Company information and summaries for each entry
  • Details on more than 1,300 med-tech mergers & acquisitions
  • Revenue data going back 10 years (as available)
  • Comprehensive lists of each firm's leadership personnel

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How to Improve and Accelerate Medical Device Testing with Imaging Analytics
Image IQ

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.

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MassDevice Big 100 Sample
MassDevice.com

The MassDevice Big 100

The MassDevice Big 100 details the world's 100 largest medical device players, ranked by 2010 revenues.

The book features:

  • Company information and summaries for each entry
  • Details on more than 1,300 med-tech mergers & acquisitions
  • Revenue data going back 10 years (as available)
  • Comprehensive lists of each firm's leadership personnel

At only $99, this might be one of the best deals in med-tech today.

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How to Develop a Clinical Study Site Budget
RCRI, Inc.

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.

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Five Steps to achieve sales success by unifying customer knowledge
Exceed Sales

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.

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MedPanel Q1 Innovation Pulse
MedPanel

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.

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Overview of the medical device approval process in major markets worldwide
Emergo Group

A reference tool of regulatory processes for the medical device industry in Australia, Brazil, Canada, China, Europe, Japan, Korea, Mexico, Russia and the USA.

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OVERVIEW OF A PARAMETRIC RELEASE VALIDATION FOR EO STERILIZATION
Steris Isomedix Services

A guide to using parametric release as a method of sterilization.

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Biomedical Adhesive, Surgical Textile and Hypodermic Needle Testing
Admet

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.

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FEA of Prosthetic Lens Insertion During Cataract
Simulia

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.
 

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Case Study: Fracture analysis of battery cans for pacemakers
Simulia

A case study performed with Medtronic Inc. on the stresses in a battery housing used in Implantable Pulse Generators (IPGs), also known as pacemakers, using Abaqus/Standard.

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Optimization in the Vibro-­Acoustic Design of Hearing Instruments
Simulia

In this technology bride we outline how Abaqua/Standard and Isight can be combined in a process to optimize the vibro-acoustic characteristics of hearing instruments.

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Simulation  of  Implantable  Nitinol  Stents  
Simulia

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.

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Overview of an ethylene oxide validation
Steris Isomedix Services

A guide to ethylene oxide validation.

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Overview of Gamma Irradiation Validation
Steris Isomedix Services

A step-by-step guide to Gamma Irradiation Validation.

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Medical Device Product Launches: Issues & Answers About Timing
Schwartz Communications

The secrets to a successful medical device product launch from a public relations perspective

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Communicating financial value when customers are only worried about reimbursement
Medical Educational Training Associates, LLC (META)

A how-to guide to selling the financial value of your medical device to the hospital decision-making tree.

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Successful medical device development: Critical Factors
Clinquest

A look at the critical business issues companies need to address when developing medical devices.

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Which type of clinical database is right for your medical device trial?
Medical Device Consultants, Inc.

This FDA and other regulatory bodies worldwide are concerned with the integrity of clinical trial data collected during new product development or required for post market surveillance activities. This paper looks at the differences between electronic data capture systems and paper systems.

 

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Patient Registries
Regulatory and Clinical Research Institute, Inc. (RCRI, Inc.)

The primary focus of this article is on patient registries designed to evaluate patient outcomes that include at least one of the following: disease progression, cost effectiveness, clinical effectiveness, safety, and/or quality of care.

 

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Human Factors and Usability in Medical Devices
Regulatory and Clinical Research Institute, Inc. (RCRI, Inc.)

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.

 

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FDA Inspection Trends
Regulatory and Clinical Research Institute, Inc. (RCRI, Inc.)

The FDA is implementing several new initiatives to maintain better oversight of contract research organizations conducting clinical trials. This paper looks at some of those changes in detail.

 

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FDA Review Patterns of De Novo Submissions
Boston MedTech Advisors

The objective of this analysis was to assess whether timelines associated with the De Novo Process are in line with FDA’s stated goals.

 

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Ground Bond vs. Ground Continuity: Why choose one test over the other?
Quadtech

Trends in the purchase of test equipment indicate that production line electrical safety is moving away from the traditional ground continuity test in favor of a ground bond test. This paper examines the differences between the two tests.

 

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Why U.S. Medical Device companies should consider partnering with companies in India
Kevin Norris, Vice President, Marketing Veol Labs

A look at the advantages of using outsourcing partners in India.

 

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Regulatory and Business Updates on Asia's Medical Device Markets
Ames Gross, President, Pacific Bridge Medical

This article provides the most recent regulatory updates in Japan, China and India to help gain entry to those markets.

 

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The Medical Device Plug-and-Play (MD PnP) Interoperability program
CIMIT / Massachusetts General Hospital

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.

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How do healthcare providers get paid
Medical Educational Training Associates, LLC (META)

A field memo for medical device sales representatives on the different way hospitals and healthcare providers receive payment from their system. Find out about the difference between coding, coverage and reimbursement. For more information

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Understanding the Unique Circumstance of Massachusetts Medtech Companies
MS&L Worldwide

A look at the strategies that will best address the challenges
facing Medtech Corporate Communications in 2010.

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How Does Your Corporate IQ Compare to Your Medtech Competitors?
L.E.K Consulting

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
 

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Silicone Molding Design Manual
Albright Technologies Inc.

This manual contains valuable information about working with silicone vs. thermoplastics, silicone use for medical applications, choosing the right silicone for the intended purpose, molding and tooling issues and much more.

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Medical Device Regulatory Approval Process Charts
Emergo Group Inc.

Color charts clearly explain the regulatory approval process for medical devices in each of the following countries: AUSTRALIA, BRAZIL, CANADA, CHINA, EUROPE, JAPAN, KOREA, MEXICO, RUSSIA, USA

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Epidemic Incidence of a Little-Known Disorder
Mederi Therapeutics Inc.
As many as 20 million young American women may be silently suffering from a debilitating disorder that few have ever heard of and even fewer admit to. That disorder is bowel control disorder.
 

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