A Frank Discussion on Economic Operators and How Maetrics Can Lead, Guide and Support Compliance Teams Ahead of the American Medical Device Summit, we spoke with Peter Rose to discuss economic operators, how Maetrics can guide compliance teams, and what steps manufacturers need to take.
Read More →Leveraging Artificial and Business Intelligence to Drive Productivity Improvements
Jaime Velez, Co-founding Partner and Senior Consultant at Operations and Quality Systems Improvement Experts (OQSIE), will join us at the American Medical Device Summit 2019, where he will speak about “Leveraging Technology and Artificial Intelligence to Accelerate Improvements in Effectiveness and Productivity in the Supply Chain.” Ahead of the summit, we spoke to Jaime about the importance of leveraging artificial intelligence (AI) and business intelligence (BI), how medical device manufacturers can begin to do this, and how OQSIE can help.
Read More →Ask the Expert: EU MDR
HCL hosted a Lunch & Learn Roundtable Discussion at the American Medical Device Summit 2018 last month in Chicago, IL. The session, “Ask the Expert – MDR and Lifecycle Management”, was led by Associate Vice President, Hilde Viroux. Hilde addressed questions surrounding the uncertainty of EUDAMED and UDI, the transition period, and how to obtain compliance. This is an excerpt from an interview Generis Group did with Hilde Viroux, AVP, Regulatory of HCL, America Inc. prior to the American Medical Device Summit 2018. “What are some of the biggest challenges in the new MDR that will impact device manufacturers? There are a lot of changes in the EU MDR that impact device manufacturers. Generating clinical data for all devices, developing the required reports and updating technical files to be compliant with Annex II and III is where most of the budget will typically go. In addition, there is the requirement to trace hazardous substances in devices and identify them on the label. The new regulation also requires manufacturers to set up a proactive approach to following the performance and safety of the device throughout its lifecycle.”
Read More →Security-First Mindset Drives Both Performance and Profits
Designing with security in mind is proving to be essential for OEMs in the embedded space. But exactly what that means remains a moving target: What’s secure today is not necessarily secure tomorrow. In volatile industry environments where threats are non-stop, OEMs want to secure their devices and systems, but don’t necessarily understand how to maintain protection for the long term. A smart approach features design strategies and standards, but as importantly, is grounded in a security-driven mindset that embraces security implementations and deals proactively with different risks. This kind of vigilance can prevail in many ways: protecting systems, distinguishing OEMs, and driving new opportunities to create long-term profit centers from security services.
Read More →De-Risking in the MedTech Industry
Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.
Read More →Leveraging Artificial and Business Intelligence to Drive Productivity Improvements
This is an excerpt from an interview Generis Group did with Jaime Velez, Co-founding Partner and Senior Consultant at Operations and Quality Systems Improvement Experts (OQSIE) prior to the 2018 American Medical Device Summit. “By combining AI and BI, companies can get the best of both worlds – speed and scale. They benefit from the massive data-processing capabilities and speed of computers (AI), combined with actionable, business-impacting information driven by analysis, exception identification and escalation protocols (BI). What is the number one reason to begin thinking about leveraging AI/BI? Speed is the biggest reason. Today’s businesses have massive amounts of information generated by more and more sources. In many ways, there is a human factory of people spending significant amounts of time accumulating, organizing and manipulating data. Instead of using data to drive rapid decisions, achieve business objectives and generate a profit – companies are spending time and resources to find relevant information buried in their data with often such a lag in time that the issues needing attention have happened without a timely response. This is where AI and BI can make a huge impact – by making large amounts of data actionable. A combination of AI/BI system assimilates and analyzes large data sets, but also allows for the right conclusions to be consistently made, at the speed of computing. It finds patterns in data, augmenting human analytics and automates escalating the exact piece of information, in the most appropriate …
Read More →Reduce Supplier Risk, Reduce Organizational Risk
Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.
Read More →Why You Need a New Quality Management System
With technology rapidly changing, a global market, and competition around every corner, quality is one of the most important factors in manufacturing. Quality in products and process will ultimately keep any organization relevant in today’s marketplace. Additionally, having an efficient, paperless, and compliant QMS System can give an organization a competitive advantage.
Read More →Membrane Switches vs Touch Screens for Medical Device Applications
Membrane switches first debuted in the 1980s, as low-cost and fairly low-tech user interfaces. Though many still hold this perception of them, membrane switches have advanced significantly over the last 30 years to the point where today’s applications are virtually unrecognizable from their first uses. As people have become fully accustomed to using touchscreens in their day-to-day lives, we are seeing the use of these interfaces expand into other areas, including the medical device market. Though touchscreens are slick and offer a familiar user experience, the membrane switch offers significant advantages over touchscreens, with high durability, and a more precise and pleasing user experience. In advance of the American Medical Device Summit, we spoke with Ken Boss, resident interface guru at JN White, about why membrane switches are still the ideal user interface for the medical device market.
Read More →The Medical Internet of Things (MIoT)
The Internet of Things (IoT) has emerged as something of a phenomenon in the last few years. The concept has become so popular that its impact is being felt across many industries. The healthcare industry is no exception. It is playing a leading role in this transformative process. Five years ago, the medical connectivity market was largely insignificant but has caught up rapidly. The market is expected to grow an astounding CAGR of 38% until 2020 by adopting the capabilities of the IoT. This intense growth is due to the increasing connectivity of medical devices and personal health tracking devices on the market, leading to an explosion in healthcare big data. Medical equipment, personal health and fitness trackers collect terabytes of data each day, most of which goes unutilized. In the future, the application of advanced analytics to healthcare ‘big data’ will have far-reaching implications on the industry overall, with the global healthcare analytics market expected to reach $20.8 billion by 2020.
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