The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices are used by patients instead of trained healthcare providers, user error is common and can impact the patient’s wellbeing. In addition, since the devices are typically placed in open cavities such as the nose or mouth, contamination of the device from viral or bacterial particles found in those cavities can decrease the safety of the device.
In this webinar designed for inhalation device engineers, learn how to use porous polymer technology to create a single custom component that can solve these multiple design challenges and bring your new inhalation device to market. Regardless of system design, porous polymers can be used to direct flow with precision, meter dosing, and filter out viruses and bacteria. With the increasing trend towards delivering drugs to the central nervous system via the nasal cavity, engineers will learn how porous polymers can be used to enable precise and calculated dosing in this specific type of design.
When you attend this webinar, you will:
In today’s competitive landscape, becoming a trusted supplier to the top medical device OEMs is no small feat. One seemingly minor problem can quickly cascade throughout the supply chain and impact a company’s reputation.
Join Bryan Barrera, COO at Trademark Plastics (TPI), and Steve Bieszczat, CMO at DELMIAWorks to learn the strategic actions TPI has taken to build a reputation of a trusted supplier to the industry’s top medical device OEMs. This webinar will focus on the steps necessary to achieve a number of critical goals, including:
When the Covid-19 crisis hit, many medical device manufacturers were unprepared for the impacts and the dramatic increase in demand for medical products from both healthcare workers and consumers. Companies struggled to manage their inventory, data, development, production, and distribution across multiple locations and the poor visibility into overall quality was leaving room for errors and costly scrap/waste.
In this webinar, hear how such a company—Burlington Medical—took the opportunity to address these challenges head-on. As a manufacturer of a wide array of high-demand, radiation protection garments and supplies, including an innovative virtual personalized fitting service for lead aprons, Burlington Medical was still determined to meet the significantly increasing output, while having the best delivery lead times and overall value for their customers. Burdened with a poor quoting tool and disconnected manual compliance and quality processes, however, the company struggled to adequately meet their current and longer-term business objectives. They needed a closed-loop system to help them lower costs and provide actionable insight into areas needing improvement to increase their customer satisfaction.
Representatives of Burlington Medical share how they overcame their struggles through a digital transformation and achieved real-time insights across operations for faster, more efficient resolution of customer demand, all while building a foundation on which to run their entire manufacturing operation.
This webinar will provide a basic overview of the FDA's regulatory process for regulating medical devices. The regulatory pathways for multiple classifications of medical devices will be presented, along with an overview of the process to take a new device from concept to commercialization and the associated challenges.
As wireless technology continues to advance, the number of consumer and industrial radio products is increasing exponentially. Wireless coexistence testing measures how multiple electronics interact in a single environment, helping manufacturers create effective products in increasingly crowded bandwidth. This testing is vitally important for safety-critical wireless medical devices to ensure their safe operation. The FDA has issued updated guidance on radio interference in medical devices, which makes this exploration of wireless coexisting testing timely and relevant for medical device manufacturers. Element is one of the top providers of wireless coexistence testing, and our experts can help ensure your wireless compliance and product testing strategy is robust.
In this hour-long webinar, Element expert David Schaefer will explain how wireless coexistence testing helps to mitigate the risk of interference and provide safe products for patients worldwide. The webinar will explore:
NOW AVAILABLE ON-DEMAND
Recalls, Market Withdrawals, Field Corrections, Safety Alerts
If there’s one thing common across manufacturing industries that companies can agree on, they hate recalls.
There are so many internal quality, external market and unexpected supplier factors that can lead to the very difficult decision to pull back product from the market, or worse yet be told by the FDA to do so. A product recall is potentially the most risk-laden situation a company can face and this risk is increasing, as supply chains grow more complex and the regulatory landscape becomes more robust. Whether your business is Food & Beverage, Pharma, Medical Device or Biopharm your company is vulnerable to these unfortunate events. In the least of cases, faulty products or contaminated foods are an inconvenience for the unlucky buyers. At worst, recalled products are linked to injuries, illnesses and even deaths. For manufacturers, recalls batter brand reputations, bottom lines and share prices.
Yet businesses can often underestimate the impact of a recall, the negative effect it can have, and the great amount of money and resources needed to manage it. It’s backbreakingly hard work. So how do you avoid such a costly and disruptive situation within your own company? Knowledge is power and in this webinar, we will take a closer look at the latest FDA guidance and trends regarding these sometimes avoidable situations and review some of the best practices to help manage them.