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Lab-Developed Tests vs In Vitro Diagnostics - Balancing patient safety, access, innovation, and commerceOn July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development. Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast. FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself. What are the issues? Why the concern? What does it all mean, and where might the Agency go? |
ERP and PLM: Defining Roles and Creating a Collaborative Environment for SuccessMedical device manufacturers’ business needs have changed significantly over the past several years, evolving the roles that technology plays within their manufacturing process. Two key technologies—Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM)—have developed into critical success factors for these manufacturers. Each technology brings unique value to the enterprise, and when combined, ERP and PLM provide a wholly collaborative environment that has a major impact on successful product development performance and the ability to maintain a competitive advantage.
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Perfecting Surface Adhesion of Coatings with Plasma FieldsSurface tension keeps pond-skating insects from sinking and soap bubbles from popping. However, in other areas of life, it can cause adhesive contact surfaces to fail, medical tubing to block – and worse. Determining the surface energy of a polymer surface is critical to ensuring proper coating quality, as well as the adhesion properties – especially with the growing popularity of water-based inks, coatings, and adhesives. |
UV Disinfection: A Crucial Link in the Sterilization ChainUltraviolet sanitizing technology provides a range of safe, cost-effective disinfection measures that simplify the challenge of maintaining sterile products and processes, whether employed as a stand-alone measure or as part of a broader sterilization program. |
Testing for TwoBiocompatibility testing for combination products is complex and challenging, and, if not performed correctly, can have serious and costly consequences. This article identifies five major areas that a manufacturer about to embark on a program of biocompatibility testing should consider. |
Human Factors and Usability in Medical DevicesHuman Factors Engineering (HFE), also known as usability engineering or ergonomics, is the study of how humans interact with machines and complex systems. HFE entails overt consideration for all aspects of user interaction with a device and is assessed continuously during the product development process using usability testing. As medical devices are becoming more complex – due, in part, to greater availability of technology and the sophisticated tasks asked of them; human factors considerations are increasingly critical. This is particularly true for medical devices intended to be used directly by patients. |
Social Media - 'Linked In' or 'Faced Out?' The worldwide Web and social media tools are constantly pervading our day-to-day lives in new areas and through new means, providing us with an abundance of resources, information, opportunities and news. But are device makers and regulatory agencies geared to use this weapon to greater potential, or are fears of inadequate regulation stifling the multiple opportunities that the new Web 2.0 offers?
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Pediatric Devices: Small Sizes, Big Challenges, Bigger Hopes Pediatric device development can be difficult. Children are smaller, but more active than adults; their body structures and functions change throughout childhood; they could be long-term device users creating concerns about device longevity and long-term exposure to materials; the market is small, yielding low ROI; funding is scarce... Yet, in spite of all these challenges, the regulatory process is quite stringent. Here's a look at some of these challenges and some positive developments taking place in this important segment of device development. |
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EDITOR'S CHOICE:
Devine Guidance: Corrective and Preventive ActionIn this edition of Devine Guidance, Dr. D provides guidance for 21 CFR, Part 820 – Subpart – J, Corrective and Preventive Action (CAPA), specifically (820.100). A strong CAPA system will allow organizations to track quality problems to closure. CAPA is not rocket science: you identify problems and you fix problems.
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| Online Survey |
1) Social media sites such as LinkedIn, Facebook, Twitter and MySpace are constantly pervading our day-to-day lives in new areas and through new means, providing us with an abundance of resources, information, opportunities and news. How do you use these tools with respect to the device company you work for?
Do you use social media networks as part of your day-to-day work? 2) If yes, for what purpose
3) What are your thoughts on current FDA guidelines with respect to marketing devices via social media networks? 4) What’s your level of expertise in using social media effectively for your medical device related needs?
5) Tell us about your company: Number of employees
6) Tell us about your position: Your Comments:
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