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
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.
Imaging Benefits of Silicon Nitrade Spinal Implants
Amedica
A look at imaging characteristics that clinicians have identified, which affect spinal implant performance
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
Schwartz PRx Report: Healthcare Predictions 2010
Schwartz Communications
This report provides analysis and insights into the most significant trends, challenges, and opportunities in 2010 for the healthcare industry.
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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