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Examining Long-Term Storage Requirements & Needs of Biologicals

In biomanufacturing, biotechnology, healthcare technology, innovation, pharmaceutical by Trisha ArmeñaLeave a Comment

As we ramp up for the 2020 American Biomanufacturing Summit, we’re excited to share this exclusive e-book created for PHC Corporation of North America, one of our Silver Partners. In this e-book, we examine the long-term storage requirements and needs of biologicals. Here’s a key excerpt from our interview with PHC Corporation of North America: “As cell-based therapies and pharmaceuticals continue to proliferate in the market, the demand for precision cold storage will be vital to maintain medicinal efficacy and research sample viability. PHCbi refrigerators, freezers, and cryogenic products represent over fifty years of engineering excellence in temperature-controlled products. From the refrigeration platform to the control center and cabinet configuration, each model was purpose-built for the safety and viability of high-value pharmaceuticals and biologics.” Check out the full e-book here. Don’t miss out on PHCbi’s roundtable discussion at the American Biomanufacturing Summit (July 22nd @1:10PM EST) led by Carl Radosevich, Senior Manager of Scientific Applications and Collaborations. You can click here to view the full program.

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American Biomanufacturing Summit Gathers Executives to Discuss the Right Tools, Mindset and Culture Needed to Drive Productivity and Ingenuity

In biomanufacturing, biotechnology, business, Generis, healthcare technology, Life sciences, pharmaceutical by Jennifer BrowneLeave a Comment

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.

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Ahead of the Curve: Disruptive Technologies in the Medical Device Market

In automation, cost reduction, emerging technology, healthcare technology, innovation, Internet of Things, IoT, medical device, medtech by Harshini SrikanthanLeave a Comment

Technia Transcat believes the medical device industry is continually evolving. Disruptive technologies are causing a paradigm shift in the development of new devices, influencing which businesses will enter this segment of Life Sciences, and who they will market their innovative devices to. In addition, what is also critical to the medical device industry is addressing the “Soft Business” disruptive modernizations. Organizations must implement internal processes and organizational behavioral changes in order to sustain a competitive advantage and continue to grow through organic means in an industry challenged with reducing costs associated with risks of regulatory compliance and certification of supply chain solidity. Technia Transcat and Generis have teamed up to create an ebook that explores how technology is changing the medical device industry and how to harness and embrace this technological change. To access the ebook, click here.  

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Common Obstacles to Receiving Product Approvals for Global Markets – An Ebook by CSA Group

In emerging technology, healthcare technology, Internet of Things, IoT, Life sciences, manufacturer, manufacturing, manufacturing operations, medical device by Harshini SrikanthanLeave a Comment

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.

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Recent Developments in the Use of Flexible Printed Circuit Boards in Implantable Devices – An Ebook

In automation, Continuous Improvement, design, emerging technology, healthcare technology, Internet of Things, IoT, medical device, medtech by Harshini SrikanthanLeave a Comment

Over the past 50 years, life expectancy has been steadily increasing. The aging population, therefore, has steadily increased both in number and mean age. There are many neurological and cardiovascular diseases that can be best managed using implantable devices, reducing the need for medications. The key challenges for implantable medical devices are how to support low energy consumption, stable performance, and continued miniaturization. Implantable devices are not new. The pacemaker, as an example, has been around for more than 50 years. The early devices were cumbersome, with short battery life, so when the battery was low, the device had to be removed and replaced, putting a burden not only on the patient but also on medical services and the managed care system. Today these same devices are less than 3% of the size and weigh only a fraction of the former weight. The real revolution in the technology is not the size reduction, but the fact that today’s tiny implantable devices can be wirelessly monitored reducing check-up frequencies. Eltek has teamed up with Generis to create an ebook that looks at the history of implantable devices, the miniaturization of the devices, their wireless communications capabilities and their future. For more information on Eltek and to access the ebook, click here.  

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Cognition Ebook: Safety By Design

In compliance, design, healthcare technology, Life sciences, medical device, medtech by Harshini SrikanthanLeave a Comment

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.

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Life Cycle and Durability Testing for Medical Devices

In aerospace, business, cost reduction, emerging technology, healthcare technology, Life sciences, medical device, medtech, product design by Harshini SrikanthanLeave a Comment

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.

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Eurofins Lancaster Laboratories PSS Insourcing Solutions

In automation, cost management, cost reduction, healthcare technology, Life sciences, medical device, medtech, pharmaceutical, testing, workforce by Harshini SrikanthanLeave a Comment

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.  

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Temptime Ebook: Key Issues in t he Storage & Transportation of Temperature-Sensitive Medical Product s

In business, emerging technology, Engineered Plastics, facilities, facility, healthcare technology, Life sciences, manufacturing, medical device, medtech by Jennifer MiraraLeave a Comment

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.

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Averna’s Q&A Ebook: How the Internet of Things is Transforming the Medical Device Industry

In automation, Continuous Improvement, cost management, cost reduction, design, design engineering, emerging technology, healthcare technology, innovation, Internet of Things, IoT, manufacturing operations, medical device, medtech, technology, testing by Jennifer MiraraLeave a Comment

The ‘Internet of Things’ is transforming the medical world, allowing more patients to be looked after using real time data. Combining Wi-Fi and Bluetooth capabilities with current technology is allowing for a faster, more resourceful and satisfying experience for both patients and employees. With the Internet of Things(IoT) reinventing the technological landscape so rapidly, companies are struggling to keep up with the latest innovations. Companies must now test the wireless capabilities of all their medical devices to ensure their products feature seamless connectivity. With more tests being conducted and the rise of IoT, competing companies have introduced robots to automate processes in order to reduce costs. Robotic-driven production has become more economical, as robots can perform routine tasks without fatigue at a faster pace. So, how can OEMs in the medical world stay ahead of their competition with all this technological development? One way is to work with a company that excels at Design for Test (DFT) and design for manufacturing (DFM). Companies can also capture and analyze up-to-date test data. For more ways to stay ahead of the competition despite the constant changes in technology and for a deeper understanding of IoT and its impact on the medical device industry, read Averna’s Q&A Ebook here. Averna is a worldwide Test & Quality leader. Their talented team includes hundreds of engineers, system architects, developers, project managers and other professionals, as well as a network of partners such as National Instruments, Keysight Technologies …

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