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 →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 →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.
Read More →Leadership Strategies for Enabling Supplier Quality Management
When it comes to quality management, life sciences organizations all face a similar set of challenges derived from both the significant industry competition necessitating improved quality performance and reduced costs, and from ever-tightening regulatory compliance measures. Quality leaders in life sciences need to contend with these pressures while also meeting goals around innovation, and improving efficiency across the product development lifecycle in an industry that is relying more and more on a growing global network of suppliers, contract manufacturers, and other partnerships. The growing network of suppliers in life sciences means that visibility into supplier quality and across the value chain are more important than ever before, as an adverse event could quickly lead to recalls, fines, and irreparable brand damage.
Read More →Your Assets Are Talking; Are You Listening?
The data analytics revolution has the potential to transform the way companies organize, operate, develop talent, create value, and service their customers. The momentum is building in many companies, but only a few are reaping major rewards from their data. Companies are doing a great job connecting assets, equipment, and devices, as well as gathering all that information into distributed databases. However, the challenge lies in finding ways to listen to what the equipment is telling us and responding in useful, actionable, and intelligent ways that improve business operations and reduce costs. Effective listening enables companies to move away from reactive maintenance activities and move towards predictive maintenance activities. True success will come from breaking down the walls of silence between employees and the assets they are managing. Unfortunately, many asset management solutions gather and report data with little thought on how to support the change from reactive maintenance to predictive maintenance.
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