Guide: Medical Device Commercialization

In biotechnology, healthcare technology, marketing, medical device by GenerisLeave a Comment

In our previous posts we have looked into some of the challenges that documentation can present during a medical device’s development and production stage. In today’s post we wanted to take a closer look at the challenges that commonly arise in the commercialization stage and explore some simple solutions to overcome them. Seismic, a leading end-to-end content automation solution provider for life sciences firms worldwide, has created the guide below to help organizations overcome 4 common challenges in medical device marketing. Check out Seismic’s Guide below: 4-simple-solutions-to-common-life-sciences-marketing-challenges If you are joining the discussion at the American Medical Device Summit this October, don’t forget to stop by Seismic’s booth (# 28) to find out more!

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eBook: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

In healthcare technology, Life sciences, manufacturing, medical device, operational excellence, Quality Management System by GenerisLeave a Comment

Medical device manufacturers are operating in a constantly evolving environment. Aging populations, evolving healthcare systems and more stringent regulations will have a significant impact on how medical device developers operate and succeed in the years to come. With the American Medical Device Summit quickly approaching, we wanted to take a closer look at how medical device developers will be able to navigate and thrive in this shifting terrain.  Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services, generated the eBook below to help developers address their most pressing challenges and enable a new collaborative model. Check out the eBook!

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eBook: Medical Device Development Best Practices

In healthcare technology, innovation, manufacturing, medical device, medtech, operational excellence, product design, product development, Quality by design by GenerisLeave a Comment

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.

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eBook: Traceability Optimization for Medical Device Developers

In healthcare technology, manufacturing, medical device, medtech, product development, traceability by GenerisLeave a Comment

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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Point of Care Testing and the Need for Interoperability

In healthcare technology, manufacturing, medical device, medtech, mfg by GenerisLeave a Comment

Point of Care Testing (POCT) enables rapid diagnostic tests to be performed at or near the site of patient care. This allows for the immediate generation of test results which can then be instantly acted upon, improve decision-making at the time of care and shared with all members of the medical team. POCT devices are used in both a clinical and non-clinical settings.  Complex clinical tests such as cardiac or coagulation testing are often conducted within a clinical setting, however, a number of devices are used within mobile units, ambulances etc.  POCT devices must therefore plan for device use outside of a clinical setting and must consequently take into account the need for connectivity, portability, longer shelf life of reagents and kits and ensure the device usability. The digitization of medical health records has resulted in a greater need for connectivity among devices and the ability to aggregate data from multiple devices into a single, central system.  The aggregation of this data in itself can become a major challenge as providers attempt to aggregate information from multiple devices with proprietary interfaces. Wipro Ltd. advises that POCT1-A2 is the approved standard for point of care device interoperability and recommends that providers adopt a framework-based approach that can help address the challenges of integrating POCT devices by standardizing implementation across devices, leading to ease of maintenance and better ROI for medical device vendors. POCT1-A2 addresses the problems of Point of Care Testing device connectivity and message formats for information …

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Balancing Competing Priorities in Medical Device Manufacturing

In healthcare technology, industrial markets, logistics, manufacturing, medical device, medtech, mfg, Quality System Management by GenerisLeave a Comment

Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing.  Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity.  As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life. Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success. The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers: Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life. Increase patient safety by reducing the number and severity of recalls and field actions Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements. Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission. Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and …

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How Information Technology is Driving Patient Centricity

In healthcare technology, manufacturing, medical device by GenerisLeave a Comment

“The role of IT is vital in driving People/Patient centric solutions. The need for interoperability for home health devices and hospital based information systems will drive the next generation of healthcare IT.” – Phani Bidarahalli, GM & Global Head, Healthcare, WIPRO The current health system spend is not sustainable and as a result there is a growing need for more effective, value adding healthcare services.  In recent years healthcare providers have shifted their focus to become more patient and outcome centric in an attempt to achieve the required value for sustainability. Wipro is a multinational Engineering, IT and System integration services company that has been a key partner to some of the largest healthcare organizations and medical device manufacturers in the world. To understand the role that information technology plays in this push for patient-centricity, I sat down with Phani Bidarahalli, GM & Head, Global Practice, WIPRO, to gather some of his opinions and insights. Phani predicts that “the next wave of innovation in healthcare will center around precision diagnosis and measurable clinical outcomes.” Clinicians are already striving to incorporate information produced by medical devices into their decision-making processes, and with the growth of big data  we will see more and more “researchers collect and harvest data to identify patterns and develop algorithms to narrow down on disease signatures and develop better clinical pathways.” Cloud based infrastructure is also providing the unique opportunity for healthcare organizations and medical device manufacturers to provide seamless access to data and information …

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The Emerging Challenges for Medical Device Manufacturers: An Interview with Maetrics

In healthcare technology, manufacturing, medical device, mfg by GenerisLeave a Comment

Maetrics is a global, full service life sciences consultancy firm that has worked with 4 of the top 5 medical device companies, 8 of the 10 top pharmaceutical companies and 6 of the top 10 biomanufacturing companies. Given Maetrics’ breadth of experience and expertise, I wanted to sit down with Edward Tomlinson, Managing Director of Maetrics, to hear his opinions on the challenges that medical device manufacturers and the industry as a whole will face in the years ahead. So Edward, how would you say the medical device industry is progressing as a whole?  By any financial method of analysis the industry is doing very well. It is growing faster than pharmaceuticals, there continues to be a robust series of mergers/acquisitions and as the global population both grows and ages there is an ongoing upturn in the addressable market for their products. Adoption of technologies such as mobile or e-Health and 3, or 4-D printing promises many new avenues of treatment. However not everything is all roses. The regulatory agencies around the world are increasing their level of oversight in all areas from product development and approval through manufacturing, sales and marketing practices and post launch patient safety monitoring. Further, the revenue and margin from product sales is increasingly dependent on patient outcomes. In order to protect their market position companies need to not only improve their financial performance to avoid becoming a takeover target but must also up their game in product development, compliance and safety …

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