Taking Your Report from Good to Great By Brandy Chittester, Chief of Clinical Operations A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight […]
Design for Manufacturing Breakthroughs
Producing Innovative Micro Medical Devices By Lindsay Mann, Director of Sales & Marketing How to Overcome Roadblocks When Producing a Micro Medical Breakthrough When trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the […]
Global Excellence in Delivery Device Testing
Introduction There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can […]
The Promises (and Problems) of Real World Data
By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, […]
Putting patients first – e-consent in clinical trials
Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs. Patient-centric healthcare means patient-centric clinical trials As the […]
Preparing for EU MDR Product Submissions: A Sustainable Approach
By Michelle Boucher, VP of Research for Tech-Clarity Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As […]
Silicone Materials for Long-term Medical Implants: Innovate for the Future
By Feifei Lin, Ph.D., Business Development Manager, Healthcare, Elkem Silicones USA Corp. With the growth of the aging population, the number of age-related diseases has increased. Every year millions of patients sustained or improved their lives through surgical procedures involving implanted medical devices. Implants such as orthopedics, pacemakers, cardiovascular stents, defibrillators, neural prosthetics or combinational […]
How K2M Tackled UDI and What Comes Next with help from Reed Tech
Mark Zellers, Quality Assurance Specialist at K2M, is responsible for ensuring his company’s data is accurate and kept up-to-date with all sorts of outside stakeholders. One of his colleagues handles internal data management and Zellers ensures it gets to the people who need it outside K2M. A big challenge facing his team came in 2015, […]
Efficiency, Transparency and Standardization: The Roadmap for Improved Data Collection in Medical Device Clinical Trials
Implementing a unified data platform for medical device trials can yield significant improvements in efficiency, transparency, and standardization, providing resource- and budget-strapped trial teams with accessible, more accurate data for faster, more informed decisions. The era of big data has led to an influx of vast amounts of information coming from disparate sources, causing challenges […]
Join Cognition Corporation in Boston September 20-21 for NAVIGATE2018
By Nick Schofield, Content Creator Interested in networking with and learning from top voices in life science industries about the latest topics and challenges in product development? Are you looking to learn more about how organizations use Cognition’s products and services to help bolster regulatory compliance from premarket to postmarket environments? Then come to NAVIGATE2018, […]
Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity
Clinical Results in RA and Crohn’s, Looking Ahead at MS By Anthony Arnold, CEO of SetPoint Medical Inflammation – it’s a term that conjures up two very different scenarios in the body: one that is vital to healing and another that can lead to chronic inflammatory diseases. Inflammation, at its best, is the part of […]
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