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 →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 →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 →Infographic: The Guiding Principles of a Quality Management System
In today’s infographic we take a closer look at the guiding principles of a quality management system (QMS). The goal of a QMS is to maintain compliance, drive continual improvement and support efficient and flexible processes. A QMS is first established by assessing the short-falls of the current system and developing appropriate policies to achieve corporate quality goals. Once these are defined the standard operating procedures need to be implemented and personal buy-in from all levels of the organization must be achieved. Management will then monitor and review the outcomes, making additional adjustments to ensure continual improvement. Check out the infographic below for some quick insights on creating and monitoring a quality management system. For more in-depth information, strategies and best-practices attend the American Biomanufacturing Summit 2016 in San Diego this May.
Read More →Infographic: Building a Culture of Quality in Biomanufacturing
Quality management is a key focus at the American Biomanufacturing Summit 2016. Manufacturers are facing increased pressure to reduce product costs while producing “bio-better” drugs that have a vastly improved pharmacological profile. By implementing a quality management system biomanufacturers will be able to build consistency into their processes, improve efficiency, ensure profitability and drive operational and competitive advantages. Implementing a quality management system is no easy feat, the process requires an organizational evolution and involves the optimization of procedures, processes and resource allocation. To enable these changes an organization must first work to build an organizational culture that focuses on quality. The first infographic in our quality series has been created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore, Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit last year. Find out more about building a Culture focused on Quality at the American Biomanufacturing Summit 2016!
Read More →Younok Dumortier Shin: A speaker review of the American Biomanufacturing Summit 2015
We were fortunate enough to have Younok Dumortier, Director of Large Molecule Technology Platform at Janssen join us as a speaker at the American Biomanufacturing Summit last year. We caught up with Younok and asked her to share some of her opinions about the event and participating as a speaker. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the American Biomanufacturing Summit 2016!
Read More →eBook: The Digitization of Manufacturing
Technology plays a major role in efficient manufacturing and the early adoption of emerging technologies can lead to a significant competitive advantage. As a result many manufacturers are looking towards digitization to drive profitability and maintain competitiveness. To help us understand how digitization is changing the manufacturing landscape we sat down with Cognizant, a leading provider of information technology, consulting and business process outsourcing services, to gather their thoughts on this burgeoning trend. Cognizant eBook, The Digitization of Manufacturing Don’t forget to stop by Booth #15 at the American Manufacturing Summit taking place in Chicago next week!
Read More →Leading Change & Developing a Framework for Enterprise Excellence
Unpredictable geopolitical events, shifting consumer demand cycles and evolving ownership models are creating an uncertain future for many manufacturers. To remain competitive, manufacturers need to develop a framework of enterprise excellence; increasing productivity, enabling flexibility and building a sustainable, high-performance team environment and culture. Many organizations, however, struggle with the successful transition to an enterprise excellence framework. To better understand the challenges involved in affecting true change and the steps that manufacturers need to take to achieve enterprise excellence we sat down with our friends at EFESO Consulting to draw on their expertise. EFESO Consulting has been active in the consulting industry for over 35 years, supporting many of the leading global brands in both mature and emerging markets. They create tangible and measurable results, generating an average ROI of 5 to 1 in the first year of engagement and maintaining a retention rate of over 90%. Read the eBook below to explore the challenges manufacturers face when transitioning to an enterprise excellence framework and understand the role that leadership plays. EFESO eBook Don’t miss the opportunity to participate in in-depth discussions and build your road-map to achieve innovation, maximize manufacturing profitability, optimize plant floor operations and establish standardization across multiple manufacturing facilities. Join the discussion at the American Manufacturing Summit 2016 taking place in Chicago on February 29th – March 1st.
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