With pressures to drive down costs, remain compliant, and improve innovation and the safety of products, manufacturers across all industries are increasing their focus on quality management. Executives are relying on a variety of resources — across people, processes, and technology — to progress forward and achieve process excellence. But before a company begins an initiative related to improving quality maturity, it’s important to understand the various phases of maturity and to define objectives for how to advance maturity from one phase to the next. Ahead of the American Medical Device Summit, we spoke with Roxane Napoli, Associate Director of Product Marketing at IQVIA Quality Compliance, to discuss how organizations within the medical device space can progress forward and improve their quality management capabilities.
Read More →American Biomanufacturing Summit Gathers Executives to Discuss the Right Tools, Mindset and Culture Needed to Drive Productivity and Ingenuity
From June 18-19, biopharmaceutical executives and cutting-edge technology providers are meeting in San Fransisco to discuss industry challenges and opportunities, quality as a culture, supply chain management, and new technologies.
Read More →EQMS and Quality 4.0: Build a Successful Quality Strategy for a Life Science Company
Quality is a critical concern in life science manufacturing industries, and leaders across life science companies have many quality and compliance considerations. However, few of those concerns have the strategic impact that Quality 4.0 does. Quality 4.0 is the digitalization of quality management through the application of traditional and Industry 4.0 technologies to improve quality monitoring and outcomes. At its core, Quality 4.0 is the digital continuum of quality data combined with other data from sources such as manufacturing, machine sensors, supplier management, and in-service across a product’s life, new analytical insights derived from that data, and the organization-wide transparent consumption of insights.
Read More →Biopharma M&A Outlook for 2018
Biopharma M&A activity has already been big news in 2018. On January 22, it was reported that Celgene had bought the 90% of Juno Therapeutics it did not already own for $9 billion, just weeks after they announced the purchase of cancer startup Impact Biomedicines. This news fits within a few broader trends we are seeing in the biopharma industry and sets the tone for this year, in which we expect to see a lot more M&A activity in the industry. Tax reform in the United States, particularly a lower levy on US companies’ overseas cash, means we will see companies repatriating these funds and likely spending them on M&A activity. This M&A activity will lead to consolidation in increasingly-crowded categories, such as cancer therapy, and there will be a continued focus on young or early-stage development companies.
Read More →Common Obstacles to Receiving Product Approvals for Global Markets – An Ebook by CSA Group
As social, economic, technological and environmental factors changes at a rapid rate, so are medical devices and healthcare equipment. The consistent changes are bringing complex challenges that require manufacturers to keep up with the rapid pace of innovations, while still maintaining safety for both professionals and inexperienced home users. Many companies only have experience with single-country access and therefore may lack understanding and expertise of regulatory or technical requirements in other countries. With such a wide array of regulations from country to country, companies can struggle with how to begin the process of meeting the required conformity for their target markets. This issue can be compounded by a lack of internal resources dedicated to compliance issues. In this constantly changing environment of safety, conformity, and market access requirements, it is even more important to not only respond to the regulatory needs of today but anticipate those of tomorrow. CSA Group’s Ebook, Common Obstacles to Receiving Product Approvals for Global Markets, explores the common challenges and misconceptions in product approvals, the key stakeholders involved in the approval process, the geographical differences in the approval process, the role of a third-party testing agency, and clearing common hurdles to product approvals. To access the ebook, click here.
Read More →Cognition Ebook: Safety By Design
Cognition’s latest ebook “Safety by Design: Guided compliance for risk reduction in medical device production and commercialization,” explores how to mitigate risk during the device developmental process. The ebook looks at pressing topics such as understanding the challenges that surround the meeting requirements of the FDA and other regulatory bodies, FDA’s position on risk reduction and automatic traceability. When submitting for regulatory approval, companies need to demonstrate that they have used a well-defined, documented design control and risk management process in place, along with evidence that they are following it. Cognition’s Cockpit Platform provides templates that are configurable to meet common standards and regulations. To access the full ebook, click here.
Read More →Life Cycle and Durability Testing for Medical Devices
Wineman Technology are specialists in military/aerospace and provide custom systems integration, automated test systems, machinery and controls modernization, and software development. As experts in this field, Wineman Technology has decided to enter the medical device industry and transfer their skills and knowledge into this field. Wineman Technology is uniquely positioned to help life science domain experts with medical device testing, as well as building cutting-edge biomedical system test architectures and database solutions. With their strong background in systems integration, software development, and turn-key test system design, they can deliver advanced equipment more effectively and on a tighter schedule than in-house design resources, or work with your team to augment your current capabilities. Wineman Technologies’ latest ebook explores the most common challenges and mistakes in medical device testing, how to implement device testing with manufacturers while saving time and costs, and how software infrastructure influences the efficacy of medical device testing. Lastly, the ebook shares a case study that shares the results of a universal test system that Wineman Technologies created for Stryker. To access the full ebook, click here.
Read More →Eurofins Lancaster Laboratories PSS Insourcing Solutions
Eurofins Lancaster Laboratories PSS Insourcing Solutions is a program that places a team of experts in the client’s laboratories with access to their quality systems in order to execute a project in the client’s scope of work. By adopting this insourcing approach, organizations are able to benefit from the expertise of an experienced laboratory testing provider, while reducing costs as they continue to keep projects, methods and analytical techniques in-house. With more than a 55-year track record of scientific and laboratory operations expertise, PSS ensures that each team of experts are top quality and selectively chosen for the appropriate project. This in-house approach is preferred by pharmaceutical and biopharmaceutical companies as opposed to hiring temporary staff. Temporary staff solutions result in valuable resources being used for recruitment, training, and managerial purposes, which could be redistributed to another area. Temporary staff also often result in conflicts with long-term needs, European regulations, and strict IRS guidelines. Benefits of insourcing include lower headcount, avoiding high turnover, condensing product development cycles, flexibility and more. PSS’s Insourcing Solutions has grown exponentially, currently, employing more than 1,500 employees, as well as serving clients in 15 countries at more than 70 different sites worldwide. You can find more information on the PSS’s Insourcing solutions in their ebook here. For more information on Eurofins, visit their website here.
Read More →Temptime Ebook: Key Issues in t he Storage & Transportation of Temperature-Sensitive Medical Product s
Temptime innovates cost effective monitoring solutions for environmentally sensitive products to ensure supply chain integrity, protect patients and benefit communities globally. The emergence of the storage and transportation of temperature-sensitive medical products has given Temptime the expertise and knowledge to resolve prevalent issues in this field. Temptime has narrowed down the key issues to the following: – Evolving Regulatory Oversight – Customer Complaints & Patient Safety – Impact on Financial Performance Temptime has identified that organizations have a challenge balancing the requirements of regulators and the needs of patients when adhering the temperature monitoring regulations. Another challenge is reducing costs and positively impacting the financial performance of a company. Temptime has unique solutions that can significantly reduce product returns and gain a competitive advantage in the market by enhancing the customer experience. For more information on key issues and solutions in the storage and transportation of temperature-sensitive medical products and solutions, read Temptime’s ebook here. To visit their website, click here.
Read More →Verification Stations for 10 Different Advanced Medical Devices
“The Challenge: Are there any devices more life-critical than those used by our doctors and nurses? You want to be absolutely sure that each one will work exactly as designed, 100% of the time. That’s why there is so much oversight on the industry. Every player needs to get it right.” Averna and Spacelabs Healthcare has collaborated to create a verification station that can test 10 different medical devices. Their case study explores the results and benefits of this project. For more information, click here.
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