Geometric Limited is a specialist in the domain of engineering solutions, services and technologies. I turned to Geometric earlier this week to draw from their expertise and gain a greater understanding of the processes and benefits of cost optimization for manufacturers. I learned that cost optimization is often thought of as a cost reduction exercise, however established products have inherent costs “built-in” to the product. Manufacturers with established products must focus on post-production expenses and work to reduce material costs and manufacturing expenses, while most of the cost structure for the product is already set because of the product specifications and decisions that were made during the development stage. The experts at Geometric advise that by pursuing cost optimization initiatives during the product development stage “companies can create significant cost optimization through better understanding and evaluation of cost drivers across the entire product realization value chain”. There are, however, five potential barriers to achieving full cost optimization during development and these may arise due to the inherent nature of the product development stage. In this weeks infographic we explore these barriers as the first part of our ‘Cost Optimization Series.’
Read More →Why You Should Create a Collaborative Culture in the Pre-Development Stage
The medical device industry has seen substantial growth in past years and the need for innovative, value-driven devices is rising. The sustainability of the current healthcare system, however, is dependent on minimizing spend and maximizing resources to ensure that for each dollar spent, there is some improvement to the health and quality of life of the individual. In order to achieve the necessary value and quality in the design of new devices, more and more manufacturers are striving to develop a collaborative culture in which the needs of the patient and those of the end user, such as the nurse, physician or other care giver, are taken into account during the pre-development stage. James Donnelly, Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics says “it’s not just how the patient benefits from a product, procedure, or test result—it’s everybody in between us and the patient that also need to be considered. It’s how the device and its functions will fit into their workflow and how it will add value to their system. You can build the best product in the world, but if they can’t use it in a way that is efficient and cost effective for them, it will fail.” “Device manufacturers need to look now and act fast to understand whether or not, in this changing environment, they are still creating products that represent today’s definition of state-of-the-art while anticipating what is needed in the future,” Donnelly says. “By bringing the patient and user perspective …
Read More →The Implications of a Changing Healthcare Environment
An Interview with Siemens Healthcare Diagnostics’ Dr. James Donnelly. The medical device industry has achieved significant growth over recent years, with the industry expected to generate $365 billion in sales by the end of 2015, and $460 billion by 2018 (information sourced from TÜV SÜD). The initial and continued success of a medical device is dependent on the value it brings to the delivery of healthcare, where there is a need to reduce waste in an evolving regulatory and reimbursement climate. Prior to his speaking engagement at the upcoming American Medical Device Summit 2015 in Chicago next week, we had the opportunity to sit down with James Donnelly ,Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics to gather his perspective on the medical device industry in the U.S., and understand how changes to the healthcare system will influence the industry moving forward. Donnelly has been with Siemens for more than eight years, beginning as Global Vice President of Medical, Clinical and Statistical Affairs. He is passionate about integrating customer input, quality, and innovation into the design of products. He also believes the customer must be an active partner in product lifecycle management and that innovation without purpose will not consistently add value to the healthcare system. Jim, how would you describe the current healthcare environment in the U.S. for medical devices? The current healthcare spend is not sustainable. We spend too much on healthcare delivery without the expected return in value. The healthcare system and its stakeholders are all experiencing significant …
Read More →Point of Care Testing and the Need for Interoperability
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 …
Read More →Balancing Competing Priorities in Medical Device Manufacturing
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 …
Read More →Analyzing Potential Manufacturing Plant Locations
Establishing a new facility is a complex process that requires a large investment and detailed analysis of internal production needs, facility features and location requirements. The first step in this process is to select the country and region that best satisfies manufacturing needs. Mexico has rapidly become a top destination for medical device manufacturing. Executives and trade organizations cite major cost savings and ease of business processes as some of the main reasons for selecting Mexico. I sat down with our friends at Co-Production International to gain a clearer understanding of how manufacturers analyze the opportunities available for site location and learned that some of the main factors influencing site assessment are: Ease of trade: free trade zones & intellectual property rights (such as NAFTA) Proximity to major markets (in Mexico’s case this is the US and Canada) Social infrastructure: investor friendly attitude of the community Established commercial infrastructure (land, facilities, transportation) Labor supply: low-cost, highly skilled workforce Supply chain access and exposure / proximity to potential new clients and suppliers Economic stability, safety and security Co-Production International explained that the reason for Mexico’s growing popularity is that it has strengths in all of the above categories. From temporary imports for final assembly to full production operations, Mexico’s medical device sector is equipped to handle a broad range of medical device manufacturing activities. Contact Co-Production International for a labor cost analysis that will demonstrate the overall cost of manufacturing in Mexico …
Read More →How Information Technology is Driving Patient Centricity
“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 …
Read More →The Emerging Challenges for Medical Device Manufacturers: An Interview with Maetrics
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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