Generis Group is honored to have Palani Palaniappan, EVP, Innovation and Development at Terumo BCT join the speaker faculty at the upcoming American Medical Device Summit 2016. With the summit right around the corner, we took the opportunity to sit down with Dr. Palaniappan to gather his insights and discuss the importance of ‘Design Thinking’ in the journey from concept to commercialization. Check out the eBook!
Read More →Whitepaper: Why Production Forecast Affects Sterilization Method
A validated sterilization cycle is a requirement for many medical devices, and the appropriate sterilization method will depend on two main factors. The Phase2Medical Whitepaper below discusses these factors and demonstrates the effect that production forecasts have on the up-front and long-term costs for two of the most common sterilization methods. Check out the Whitepaper below! Don’t forget to join Phase2Medical at the American Medical Device Summit 2016 taking place in Chicago next week!
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 →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 →eBook: Medical Device Commercialization Best Practices
The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on medical device developers to speed their time to market while providing higher quality products, at less cost. Navigating this shifting terrain and enabling a quick time to market can often be a challenge. In this eBook, we sat down with Cognition Corporation, compliance and medical device solutions specialists, to gather their insights on the commercialization challenges that medical device developers face and the best practices to overcome them. Check out the eBook below: Medical Device Commercialization Best Practices
Read More →The Benefits of Test Engineering Services for the Entire Product Life Cycle
Medical device developers are under increasing pressure to develop new features and better quality products while speeding time to market. One of the ways that developers are achieving this goal is by adopting automation software that will allow them to streamline their product development and test times without sacrificing quality. Averna, a Test Engineering leader, generated the video below to highlight the benefits of automation software and explain how it can help address some of the biggest challenges that medical device developers face. Check out the video below:
Read More →Surface Preparation for Medical Device Manufacturers
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, allows for subjective interpretation, and are often destructive. We sat down with BTG Labs to find out more about the challenges of surface preparation and how manufacturers can effectively overcome them. Check out the eBook below! eBook Surface Preparation for Medical Device Manufacturers
Read More →eBook: Medical Device Development Best Practices
With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them. Check out the Stratos eBook to explore : Complications arising from a lack of proper documentation, and how to overcome them. Strategies to speed the product development process while effectively managing costs. Tactics to make product launches more predictable. Regulatory considerations that need to be factored into the medical device development process in the U.S. The benefits of outsourcing innovation. eBook, Medical Device Development Best Practices For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.
Read More →Whitepaper: Transitioning to Agile
Safety-critical industries face many challenges including stringent regulations and requirements, and increased pressure to speed time to market while improving product quality. As a result, it is often difficult for organizations to move away from traditional development processes and integrate agile methodologies. Seapine Software has generated the whitepaper below to help medical device manufacturers overcome these barriers and successfully transition to agile in a safety-critical environment. To hear more from Seapine Software, join the discussion at the American Medical Device Summit taking place this October!
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