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

product launch preparation.
  • Phase 5: Product launch and post-launch assessment.

    Pietzsch adds that the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies, stricter regulatory requirements, and the increasing importance of reimbursement decisions.

    The Role of FDA's Quality System Regulation

    The study results demonstrate that a significant portion of the development process is governed by regulations that influence the manner in which medical devices are developed, approved, and brought to market. The pace at which such regulatory requirements can be met determines when the device will reach the clinic.

    Specifically, FDA's Quality System Regulation plays a substantial role in the development process and serves to assure the public that critical elements of safe design practices are followed. However, the researchers point out that such standardization does not always permit product developers to streamline their processes where it would make sense. In turn, such rigidity can inhibit innovation, which often occurs in a less-structured way.

    "Clearly there are benefits associated with having a rigorous process and clearly defined procedures for all stakeholders in the processfrom investors and engineers to researchers and regulators," says coauthor John Linehan, Ph.D., professor of medicine and biomedical engineering and director of the Center for Translational Innovation at Northwestern University, and a consulting professor of bioengineering in Stanford University's BioDesign Program. "The challenge for companies inventing and developing technologies is to strike a balance between sufficient process rigor and enough room for flexibility and creativity."

    Drug-Device Differences

    Among the key results of the study is a detailed explanation of the significant differences between medical devices and phar
    '/>"/>


  • 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:8/22/2014)... antioxidants and can reduce free radical damage. ... oxidative stress? Jianbo Zhao and co-workers from ... University, China discovered that green tea polyphenol ... apoptosis, indicating green tea polyphenols play a ... oxidative stress. The relevant study has been ...
    (Date:8/22/2014)... birds and the bees. But that old expression ... The fertilization process for flowering plants is particularly ... and female reproductive cells. New research from an ... and including Carnegie,s Wolf Frommer, David Ehrhardt, and ... process that guides flowering plant fertilization. It is ...
    (Date:8/21/2014)... A new study of American singles found that ... the highest orgasm rates. On average, men experience ... sexual orientation making little difference. For women, however, ... experience orgasm 62.9 percent of the time during ... pattern varies with women,s sexual orientation, with lesbian ...
    Breaking Biology News(10 mins):Calcium and reproduction go together 2Orgasm rates for single women less predictable than men's, vary by sexual orientation 2Orgasm rates for single women less predictable than men's, vary by sexual orientation 3Orgasm rates for single women less predictable than men's, vary by sexual orientation 4
    ... primitive Earth mantle reservoir on Baffin Island in the Canadian ... collaboration report the finding--the first discovery of what may be ... . The Earth,s mantle is a rocky, solid shell ... and makes up about 84 percent of the Earth,s volume. ...
    ... of yellow haze hovering over Houston as a result of ... a little bit thinner, according to a new study. ... petrochemical-producing cities around the world -- come with a catch, ... Research in Environmental Sciences, or CIRES, a joint institute of ...
    ... Blish, M.D., Ph.D., Acting Instructor in Medicine, University of ... Research Center, Seattle, has been chosen by the American ... Young Investigator Award for her outstanding work elucidating the ... by Merck, U.S. Human Health Division, this award recognizes ...
    Cached Biology News:Oldest Earth mantle reservoir discovered 2Texas petrochemical emissions down, but still underestimated, says study 2
    (Date:8/22/2014)... in the scientific journal PLoS One , ... effect of serotonin on sensitivity to pain using ... "Serotonin is a small molecule known to be ... from the control of sleep and appetite, to ... is also popularly thought to contribute to feelings ...
    (Date:8/22/2014)... The Global and China Diabetes Drugs Industry ... state of the Diabetes Drug industry in Global and ... the industry, including definitions, applications and industry chain structure. ... provided with a focus on history, developments, trends and ... international and Chinese situation is also offered. , The ...
    (Date:8/22/2014)... Nerium International, the go-to, buzzworthy skincare ... again. Nerium will showcase its signature NeriumAD® Age-Defying ... Cream to Hollywood’s elite at the official Giving ... Primetime Emmy® Awards. , Developed from cutting-edge research ... show that NeriumAD night cream dramatically reduces the ...
    (Date:8/21/2014)... 21, 2014 DNA vaccine pioneer ... its development of JRC-LAMP-vax, an innovative and safe potential ... IC studies began this month in Hawaii, moving the ... , The Japanese red cedar releases pollen that causes ... Mountain Cedar pollen wreaks similar havoc in Colorado, New ...
    Breaking Biology Technology:From happiness to pain: Understanding serotonin's function 2Diabetes Drugs Industry Growth Analysis in Global, China Regions Research Report Available at DeepResearchReports.com 2Diabetes Drugs Industry Growth Analysis in Global, China Regions Research Report Available at DeepResearchReports.com 3Nerium International Joins Television’s Biggest Stars at Backstage Creations Giving Suite at the 66th Primetime Emmy Awards 2Nerium International Joins Television’s Biggest Stars at Backstage Creations Giving Suite at the 66th Primetime Emmy Awards 3Relief for Allergy Sufferers Finally in Sight: Immunomic Therapeutics Closes in on Treatment for Hay Fever in Japan, U.S. 2Relief for Allergy Sufferers Finally in Sight: Immunomic Therapeutics Closes in on Treatment for Hay Fever in Japan, U.S. 3Relief for Allergy Sufferers Finally in Sight: Immunomic Therapeutics Closes in on Treatment for Hay Fever in Japan, U.S. 4
    ... develop the tools and find the organisms to break ... component sugars the key step toward fermentation of ... be simple and economically efficient before cellulosic biofuels can ... As with any exploration of systems that involve largely ...
    ... CHICAGO , July 26 ... Bulletin Board: ADLS), a biopharmaceutical company engaged in the ... therapeutic areas of infection, oncology and respiratory diseases, today ... research and option agreement with The University of ...
    ... July 23 /PRNewswire-Asia-FirstCall/ -- China-Biotics, Inc.,("China-Biotics", the "Company") (Nasdaq: CHBT ... , today announced,it will host a conference call at 08:00 a.m. ... the fiscal year 2011 first quarter financial results,for the period ended ... , ...
    Cached Biology Technology:New hydrolysis model promising tool in cellulosic biofuel studies 2New hydrolysis model promising tool in cellulosic biofuel studies 3Advanced Life Sciences Expands Antibiotic Pipeline 2Advanced Life Sciences Expands Antibiotic Pipeline 3Advanced Life Sciences Expands Antibiotic Pipeline 4China-Biotics to Report Fiscal Year 2011 First Quarter Financial Results on August 9 2
    ... Simultaneously perform 96 assays on four ... four microarray slides with 96 (6mm x ... protein, gene expression, or screening analysis studies. ... compression fit gasket, eliminating the presence of ...
    ... is an automated multiplexing platform that uses ... pathogen sequence detection and pharmacogenetics applications. Multiple ... to an open and flexible electronic microarray, ... until all tests sites have been utilized. ...
    ... with sequence siTrio siRNA --- a ... target gene of interestis our most popular product. ... 75% knockdown of your target gene when used ... and confirmation of optimal transfection with one of ...
    The Bio-Plex Manager version 3.0 to 4.0 workstation software upgrade kit is used to upgrade existing Bio-Plex Manager version 3.0 software to version 4.0 security edition software....
    Biology Products: