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 →Q&A with Peter Rose
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 →Quality Maturity for Life Sciences: Q&A with IQVIA
With pressures to drive down costs, remain compliant, and improve innovation and the safety of products, manufacturers across all industries are increasing their focus on quality management. Executives are relying on a variety of resources — across people, processes, and technology — to progress forward and achieve process excellence. But before a company begins an initiative related to improving quality maturity, it’s important to understand the various phases of maturity and to define objectives for how to advance maturity from one phase to the next. Ahead of the American Medical Device Summit, we spoke with Roxane Napoli, Associate Director of Product Marketing at IQVIA Quality Compliance, to discuss how organizations within the medical device space can progress forward and improve their quality management capabilities.
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 →EU MDR: Q&A With MAE Group
Significant changes are ahead for medical device manufacturers. The EU’s Medical Device Regulation (EU MDR), which is set to replace the current directive for the regulation of devices in 2020, will introduce significant regulatory changes that will impact all organizations producing or supplying medical device products to Europe. Ahead of the American Medical Device Summit 2019, Generis Group spoke with Yashesh Rawal, Regulatory Affairs Specialist from MAE Group, to discuss the major challenges of the new EU MDR, its impact on medical device manufacturers, and how organizations can prepare to ensure a smooth transition.
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.”
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