Over the last 25 years, we have watched automation technology evolve and deliver new possibilities to the assembly, inspection, and testing of medical devices. From force testing surgical devices to inspecting trocars for microscopic defects to loading drug delivery systems, automation helps complete intricate processes with repeatable results. Yet, according to many manufacturing trends, the medical device industry is slower to truly embrace automation than other fields. While most medical device manufacturers understand the benefits of shifting from manual processes to incorporate automation, there is confusion and hesitation in the industry when it comes to leveraging it effectively. The disconnect? Misconceptions about what automation is, and what it can or cannot do. So, our partner Invotec surveyed their customers—manufacturers of non-invasive surgical devices, cardiovascular technology, drug delivery systems, and bioMEMs—to learn what initially concerned them about automation, and how they overcame those challenges. To hear what they had to say, check out this exclusive e-book:
Read More →Mastering Safety-Critical Product Design
When it comes to product design, what are the most common pitfalls for businesses to avoid? And with that being said, what are the most effective design practices to ensure product safety and compliance while also making a rapid return on your investment? We sat down with the engineering experts at General Digital to learn all about mastering safety-critical product design for both long-term financial and technical sustainability. Learn more in this exclusive e-book below:
Read More →Mastering Product Complaint Handling in the Medical Device Industry
For medical device manufacturers across the globe, among their top priorities will inevitably include: complaint handling. It is crucial that continuous improvements in customer satisfaction, regulatory compliance, and the safety of consumers remain top of mind.
Read More →Shifting from Manual Processes to Automation | Medical Device Assembly
When you think about “automation” and what it means for your business, what instantly comes to mind?
Read More →Connected Manufacturing | MedTech 4.0
To this day, many Medical Device manufacturers are still operating on paper… Is your business one of them? We’re excited to share this exclusive e-book created for Seabrook Technology Group, one of our valued partners at the Virtual American Medical Device Summit! In this e-book, we examine the value of Connected Manufacturing for Medtech 4.0. Here’s a key excerpt from our interview with Seabrook: Welcome to Connected Manufacturing. Connected Manufacturing is not just a “product” or “service”, but a strategy that eliminates the shoehorning of new functionality into legacy systems. Additionally, connected manufacturing enables the “best of breed” approach that optimizes operations, enhances user experience, and maximizes value returned to the organization. We invite you to access the full e-book here.
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 →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.
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