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
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
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.
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.
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.
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.
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.
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.
OVERVIEW OF A PARAMETRIC RELEASE VALIDATION FOR EO STERILIZATION
Steris Isomedix Services
A guide to using parametric release as a method of sterilization.
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.
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.
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.
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.
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.
Overview of an ethylene oxide validation
Steris Isomedix Services
A guide to ethylene oxide validation.
Overview of Gamma Irradiation Validation
Steris Isomedix Services
A step-by-step guide to Gamma Irradiation Validation.
Medical Device Product Launches: Issues & Answers About Timing
Schwartz Communications
The secrets to a successful medical device product launch from a public relations perspective
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.
Successful medical device development: Critical Factors
Clinquest
A look at the critical business issues companies need to address when developing medical devices.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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.
