Navigation Links
Stanford researchers publish comprehensive model for medical device development
Date:6/29/2009

WASHINGTON, DCIn an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, researchers at Stanford University have published the first comprehensive model representing the medical device development process.

Published in the June 2009 issue of the Journal of Medical Devices, the model was constructed based on best-practice analysis and interviews with more than 85 seasoned experts actively involved in the development, commercialization, regulation, and use of medical devices.

"Medical devices contribute significantly to the continuous improvement of healthcare," says lead author Jan Pietzsch, Ph.D., consulting assistant professor in the department of management science and engineering at Stanford University. "Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years. As a result, successfully bringing innovative products to patients hinges on knowledge of and planning for this process."

Presented in linear form with five major phases and four decision gates, the model describes a process that is applicable to a broad range of medical technologies and innovation settings. According to the authors, the model is used by the developers of both highly sophisticated premarket approval (PMA) and premarket notification (510(k)) devices, for which FDA approval typically requires some risk-appropriate form of bench or clinical data, as well as by the makers of less sophisticated devices that may be exempt from most regulatory requirements. The five major phases and decision gates include:

  • Phase 1/Gate 1: Initiation, opportunity, and risk analysis.
  • Phase 2/Gate 2: Formulation, concept, and feasibility.
  • Phase 3/Gate 3: Design, development, verification, and validation.
  • Phase 4/Gate 4: Final validation and
    '/>"/>

Contact: Robyn Stein
Robyn.Stein@gabbe.com
212-220-4444
InHealth: The Institute for Health Technology Studies
Source:Eurekalert

Page: 1 2 3

Related biology news :

1. Stanfords Woods Institute awards new round of Environmental Venture Projects
2. Stanford scientists find heat-tolerant coral reefs that may resist climate change
3. Stanford scientists turn adult skin cells into muscle and vice versa
4. Stanford scientists find new solutions for the arsenic-poisoning crisis in Asia
5. Stanford researchers develop biodegradable substitutes for wood, plastic bottles and other materials
6. From stem cells to new organs: Stanford and NYU scientists cross threshold in regenerative medicine
7. Biofuels boom could fuel rainforest destruction, Stanford researcher warns
8. Stanford launches $100 million initiative to tackle energy issues
9. New World post-pandemic reforestation helped start Little Ice Age, say Stanford scientists
10. Powerful online tool for protein analysis provided pro bono by Stanford geneticist
11. Cell movements totally modular, Stanford study shows
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... from the Terra satellite show the different areas that have ... Russia. The burn scars show up as reddish-brown splotches ... broken across the remote parts of Eastern Russia in the ... MODIS instrument, it is still possible to see the ... features noted below show the devastating number of fires that ...
(Date:7/25/2014)... and some of the smoke from those fires is drifting ... the Moderate Resolution Imaging Spectroradiometer (MODIS) aboard the Aqua satellite ... over the Great Lakes region of the United States. ... 23, 2014 (first image feature highlighted below) clearly shows the ... In the image, it is over Manitoba and parts ...
(Date:7/25/2014)... autism and disrupted brain development is an essential ... is largely unknown. However, thanks to funding from ... Washington University (GW) researcher Anthony-Samuel LaMantia, Ph.D. may ... answers to these key questions in the field ... pharmacology and physiology at the GW School of ...
Breaking Biology News(10 mins):GW researcher receives grant to answer the how and why of autism during development 2
... research in France on patients diagnosed with cryptococcosis ... patients infected by HIV and who are profoundly ... 5 2007 in PLoS Medicine, uncovers parameters associated ... sex and the infecting serotype. In light of ...
... In a venture once thought to lie outside the ... Beth Israel Deaconess Medical Center have captured and sequenced ... Tyrannosaurus rex. The protein fragments—seven in all—appear to most ... present day chickens, lending support to a recent and ...
... international consortium of researchers has published the genome sequence ... the chimpanzee and human genomes. Published April 13 in ... reveals that the three primate species share about 93 ... among their genes. , In its paper, the Rhesus ...
Cached Biology News:New recommendations against a major opportunistic infection -- cryptococcosis 2New recommendations against a major opportunistic infection -- cryptococcosis 3Protein fragments sequenced in 68 million-year-old Tyrannosaurus rex 2Protein fragments sequenced in 68 million-year-old Tyrannosaurus rex 3Protein fragments sequenced in 68 million-year-old Tyrannosaurus rex 4Analysis of rhesus monkey genome uncovers genetic differences with humans, chimps 2Analysis of rhesus monkey genome uncovers genetic differences with humans, chimps 3
(Date:7/25/2014)... Albany, New York (PRWEB) July 25, 2014 ... Transparency Market Research, "Biological Drugs Market - Global Industry ... 2020," the global biological drugs market is estimated at ... grow at a CAGR of 10.1% from 2014 to ... million in 2020. , The biological drugs market is ...
(Date:7/25/2014)... July 25, 2014 WABC Radio show out ... with Lorry Young will be hosting California-based Vet-Stem, Inc.’s ... stem cell therapy in pets. Dr. Harman first visited ... stem cell therapy for pets suffering from osteoarthritis and other ... Veterinary Medicine industry forward. , Young has invited Dr. Harman ...
(Date:7/25/2014)... The Conferee Networking committee is pleased to announce ... two-hour sessions provide a unique networking opportunity for attendees ... new techniques, or brainstorm new ideas in an informal ... consideration is August 31, 2014, and instructions can be ... will review the topics, and status notifications will be ...
(Date:7/25/2014)... 2014 Lawrence Livermore scientists Charles Westbrook ... list of " The World's Most Influential Scientific Minds ... 3,000 researchers who were identified by analyzing citation data ... published the highest-impact work (2002-2012 and 2012-2013). The two ... combustion modeling . , "This recognition is a great ...
Breaking Biology Technology:Biological Drugs Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Biological Drugs Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3Robert J. Harman, DVM, Founder and CEO of Vet-Stem, Inc. to Join New York Radio Host Lorry Young in Upcoming Episode of A “Paws” For Your Pet 2Robert J. Harman, DVM, Founder and CEO of Vet-Stem, Inc. to Join New York Radio Host Lorry Young in Upcoming Episode of A “Paws” For Your Pet 3Pittcon 2015 Announces Call for Topics for Conferee Networking Sessions 2Scientists Burst onto Influential List for Combustion Research 2Scientists Burst onto Influential List for Combustion Research 3Scientists Burst onto Influential List for Combustion Research 4
... nothing in record numbers. , ,In 2003, an estimated 5 ... as LiveJournal , Movable Type , and Weblogger ... a New Year's resolution. , ,A November study of eight ... 20 percent of all blogs (short for "Web logs") are abandoned ...
... cursed) Sarbanes-Oxley Act of 2002 (Sarbox), many publicly ... financial recording and accounting practices and updated their ... whether privately held companies and non-profits should be ... public companies. Are taking these kinds of measures ...
... , a provider of business solutions that connect ... announced today that Hance Company of Plymouth, Minn., ... solution for integration directly with Hance's Ezone parts ... , ,Under the agreement, ARI will host ...
Cached Biology Technology:Who Gives a Blog? 2Sarbanes-Oxley for the Rest of Us 2Sarbanes-Oxley for the Rest of Us 3Sarbanes-Oxley for the Rest of Us 4