Medical device developers face an array of regulatory, compliance, quality and risk challenges. Throughout the past couple of months we have examined these different challenges and various solutions to overcome them. In today’s post we wanted to share the Jama Software whitepaper below which discusses methods to resolve the challenges of connectivity, competition and compliance for medical device developers. Check out the Whitepaper
Read More →Wait, is that Clean?
Surface preparation is a critical manufacturing process that enables sealing, bonding, painting, coating, printing and cleaning. By utilizing appropriate surface preparation processes medical device manufacturers can speed production, ensure product safety, and decrease the likelihood of recalls. Despite the critical nature of this process the majority of manufacturers are still relying upon outdated surface evaluation methods such as dyne and water break. These current methods lack precision, allow for subjective interpretation, and are often destructive. Check out the BTG Labs infographic below to explore the strengths and weaknesses of different surface preparation methods. surface-preparation-for-manufacturers-who-bond-seal-coat-paint-clean-or-print Hear more from BTG Labs by joining the discussion at the American Medical Device Summit on October 5-6 in Chicago. Be sure to stop by Booth #21!!
Read More →Guide: Medical Device Commercialization
In our previous posts we have looked into some of the challenges that documentation can present during a medical device’s development and production stage. In today’s post we wanted to take a closer look at the challenges that commonly arise in the commercialization stage and explore some simple solutions to overcome them. Seismic, a leading end-to-end content automation solution provider for life sciences firms worldwide, has created the guide below to help organizations overcome 4 common challenges in medical device marketing. Check out Seismic’s Guide below: 4-simple-solutions-to-common-life-sciences-marketing-challenges If you are joining the discussion at the American Medical Device Summit this October, don’t forget to stop by Seismic’s booth (# 28) to find out more!
Read More →An Agile Alternative to Document-Centric Methods for Requirements Management
The American Medical Device Summit is less than one month away! The summit will draw on the knowledge of over 40 industry leaders to explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. One of the companies helping developers tackle the challenges in product development and compliance is Jama Software. Jama Software has developed a more agile alternative to document-centric methods for requirements management, creating the optimal environment for defining problem statements, validating cross-functional input and ensuring that what is delivered at each phase of is what was intended. Check out the Demo Video below to find out how on-boarding this software can help developers navigate complex development cycles and build great products by: Removing the overhead of requirements reviews. Shortening the time between milestones. Mitigating risk and maintaining traceability evidence. Visualizing connections between regulations, requirements and test cases. for a more in-depth look at the software, try the software yourself by signing up for the Jama Software Free Trial!
Read More →Can you turn Regulatory Compliance into an Opportunity?
Medical device developers are evolving and introducing new products and variants into the market. With this evolution comes a more complex and dynamic global supply chain. To help navigate this shifting terrain Dassault Systèmes generated the free webinar below to help guide developers through effective techniques to create an opportunity through traceability. Check out the 35 minute free Qmed webinar on Making Traceability Work for the Business: Effective eDHR and UDI to discover: The role of integrated manufacturing software in eDHR and UDI compliance Approaches to consider for traceability program improvements Questions to raise as you assemble the diverse stakeholders for such a project Check out the Webinar!
Read More →Optimize Your Lean! Marry 5S Programs, Kanban Systems and Kamishibai
You may be familiar with how 5S Programs, Kanban Systems and Kaizan Events help drive your lean manufacturing processes, but how familiar are you with the Art of Kamishibai? Once standardized work has been developed and documented, how does your company ensure that it’s sustained? This is where kamishibai comes in. Check out the infographic below, courtesy of Phase 2 Medical, to understand how kamishibai is implemented and how it can enhance your lean manufacturing efforts. The Art of Kamishibai in Medical Device Manufacturing Interested in finding out more? Contact Phase 2 Medical for more information. If you are attending the American Medical Device Summit in Chicago this October, don’t forget to stop by Booth #30 to say hello to Phase 2 Medical in person!
Read More →Big Challenges for Testing Today’s Wearable Devices
Wearable devices have become a commodity; devices act as fitness and health trackers, work and lifestyle guides as well as medical monitors. According to The Business Insider the “global wearables market will grow at a compound annual rate of 35% over the next 5 years”. This growth will bring a range of lifestyle enhancing and potentially life-changing accessories directly to consumers and to the healthcare industry at large. As the market evolves, developers and manufacturers will find themselves faced with an array of functionalities and processes that need to be rigorously tested in order to ensure consumer satisfaction, safety and regulatory compliance. Averna, a Test Engineering Leader, generated the whitepaper “High Tech, Will Travel” to outline some of the current and upcoming challenges in testing wearable devices. A brief preview is below, click on the image or link to Download the full whitepaper! We are thrilled to have Averna join us at the upcoming American Medical Device Summit 2016! To find out more about the summit and join the discussion this October 5-6, visit: http://amdsummit.com/
Read More →Whitepaper: Beyond the ID, The Value of UDI
There has been a great amount of discussion around the impact that UDIs will have on medical device developers, manufacturers and the health care system at large. The following whitepaper takes a different approach and looks at UDI implementation from a strategic perspective to assess its true value. Check out the whitepaper below, generated by Dassault Systèmes and Axendia, to understand where the true value in this system will be expressed.
Read More →7 Tips for Transitioning to Electronic Medical Device Reporting
In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers and importers of medical devices to transition away from paper reporting, and to instead submit adverse event reports electronically. The electronic transmission of adverse event reports coupled with the mandatory reporting deadlines will allow the FDA to respond more readily to adulterated, misbranded or unsafe devices. Pilgrim Quality Solutions, created the eBook below to help manufacturers and importers transition to electronic medical device reporting. Check out the eMDR e-book! 7 Tips for Transitioning to Electronic Medical Device Reporting For more medical device strategies, join Pilgrim Quality Solutions at the American Medical Device Summit taking place on October 5-6 in Chicago, IL.
Read More →Struggling with finding a fully validated Requirements Management Tool?
Quality control and regulatory compliance are paramount in medical device development. A fully validated tool can help reduce time and effort in the initial stages of product development. Finding the right Requirements Management Tool is imperative for medical device developers operating in an extremely regulated environment. Cognition Corporation, product and process development leaders for more than fifteen years, developed the white paper below to help medical device developers navigate this terrain. Check out the Cognition Validation Kit White Paper!
Read More →