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 Despite the critical nature of this process the majority of manufacturers are still relying upon outdated surface evaluation methods such as dyne and water break.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!
Read More →The Serialization Challenge
Successful serialization strategies require a global approach and considerations regarding installation and aggregation capabilities, traceability optimization and adherence to varying regional regulations. In order to better understand the serialization challenges and opportunities that pharmaceutical companies face, we sat down with the specialists from Clarkston Consulting to gather their insights. The eBook explores and explains: The Current Regulatory Landscape The Serialization Challenge Best Practices in Serialization Operationalizing a Serialization Program Check out the eBook below! eBook, The Serialization Challenge To hear insights on Manufacturing Excellence, CMO Strategies, Capacity Management, Quality and Compliance, join Clarkston Consulting at the American Biomanufacturing Summit taking place in San Diego next week!
Read More →Managing A Cold Supply Chain
In the build up to the American Biomanufacturing Summit, we sat down with James Klingelhoefer, Regional Sales Director at World Courier to discuss strategies to best manage a cold supply chain. In the article below, James discusses the challenges and opportunities in managing a cold supply chain, explains the most important elements to manage and provides advice to biomanufacturers who may be struggling with their cold supply chain management. Managing a Cold Supply Chain To hear more biomanufacturing insights, join the discussion on May 10 – 11, 2016 in San Diego, CA.
Read More →Operational Efficiency Whitepaper: Beyond Compliance
dMedical device manufacturers are facing increasing challenges in the development, production and commercialization of their devices. To offset rising costs, evolving regulations and increased pressure to speed time to market, manufacturers are streamlining their processes and implementing strategies that drive operational efficiency. Dassault Systemes has generated an informative white paper to help medical device developers drive innovation and improve operational efficiency by creating processes that incorporate quality, engineering, and regulations. Download the “Beyond Compliance” whitepaper to learn how to Connect the Dots Between Quality, Engineering, and Regulatory to Increase Innovation and Improve Operational Efficiency. To hear more from Dessault Systemes, Join the discussion at the American Medical Device Summit 2016 taking place in Chicago on Oct 5th – 6th, 2016.
Read More →Infographic: 5 Mistakes That Can Derail Your Medical Device Development
Medical device developers have a series of hurdles they need to navigate in order to successfully bring their device to market. In today’s infographic, we explore the top five mistakes that can derail the medical device development process and consequently speed to commercialization. Check out the Infographic: 5 Mistakes That Can Derail Your Medical Device Development 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 →Medical Device Infographic: The Recall Impact
In today’s post we draw on the expertise and insights of EngiSystems to examine the growing impact of recalls in the medical device industry. The infographic below illustrates the increase in medical device recalls over the past decade and outlines some of the major challenges that have lead to this increase. Infographic: The Recall Impact For more medical device insight. join EngiSystems at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.
Read More →Video: Christopher Murphy’s Experience At The American Biomanufacturing Summit
At the American Biomanufacturing Summit last May we had the opportunity to sit down with one of our key speakers, Christopher Murphy, VP, Operations at Genzyme to hear his thoughts on participating as a speaker and on the summit as a whole. The American Biomanufacturing Summit is returning to the Hyatt Regency La Jolla in San Diego on May 10th – 11th, 2016. To find out more about the two day summit taking place next month, visit: www.biomanamerica.com
Read More →eBook: Traceability Optimization for Medical Device Developers
Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of information to ensure device safety and demonstrate that safety in the event of an audit. Given the volume and complexity of information to be tracked, many medical device developers struggle with traceability. We sat down with Seapine Software to better understand the challenges medical device developers face, and how they can be overcome. Check out the Traceability Optimization eBook below! eBook, Traceability Optimization for Medical Device Developers
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