Industry Perspectives
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How Does Pursuing ESG Measures Give My Medtech A Competitive Edge?
5/27/2022
Amid continuing focus on environmental, social, and governance (ESG) priorities among investors across every industry, medtech companies need to begin revisiting business models and developing new sustainability strategies for competitive edge as well as regulatory compliance.
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Medical Device 3D Printing & Prototyping: Lessons Learned
4/27/2022
Nearly a decade ago, this author came up with the concept for a new medical device. In bringing that concept to fruition, he looked into 3D printing and prototyping. This article describes his process and lessons learned from the experience. Fortunately, 3D printing is now more accessible and easier to accomplish for medical device developers, so hopefully your challenges will be less of an obstacle.
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How To Design Medical Devices With Sustainability In Mind
3/30/2022
Sustainability has risen to the top of the corporate agenda in many industries, including the medical device market. To maximize success, medical device manufacturers must prioritize it at the beginning of the design phase and must consider the entire life cycle of the device while balancing the need for safety, functionality, and durability.
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3D Printing For Pharmaceuticals & Medical Devices: A Primer With Risk Considerations
1/28/2022
Implementation of single-use technologies for pharma and medical device manufacturing has introduced advantages in terms of design, sterility assurance, and a reduction in energy usage. 3D printing can deliver precise measurements to production facilities. This article describes the 3D printing process, risk considerations, and limitations — but the future is bright.
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Medtech At A Turning Point: The 5 Areas To Address In 2022
1/19/2022
From 2020 to 2021, the medtech industry's revenues grew and the industry entered a period of recovery and renewal. However, as 2022 begins and we look to a future where COVID-19 becomes endemic, the medtech business model must evolve in these 5 key areas.
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How Can We Use The UDI To Improve The Device Recall Process?
1/7/2022
The Unique Device Identifier (UDI) was expected to improve patient and medical device safety by enhancing key patient safety systems like the product recall and adverse event reporting processes and improving device evaluation. AHRMM recently completed a survey of various stakeholders; this article delves into the survey's findings and the recommendations for improving the device recall process.
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4 Key Considerations For Onshoring Inbound Medtech Supply Chains
12/13/2021
Many medtech supply chains hold a significant amount of redundant inventory, from orthopedic spare parts to unutilized loose instruments. If the industry can better translate demand signal into supply chain reality and build greater flexibility, the industry could significantly downsize its redundant inventory. This article provides 4 key considerations for medtech leaders.
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Collaborative Communities: An Opportunity To Contribute To Medical Device Industry Improvements
11/2/2021
Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.
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Robotically Assisted Surgical Devices: Ripe For Innovation
10/25/2021
In the healthcare industry, the robotically assisted surgical (RAS) device sector is dominated by a few key players. In the future, several new companies are expected to enter the industry. Competition is heating up. Shifting demographic and labor trends will create a significant market opportunity that, if addressed correctly, will benefit device makers, physicians, and, most importantly, the patients.
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Medical Device Biocompatibility Testing: Best Practices & How To Minimize Risks
10/4/2021
In Part 1 of this two-part series, the author discussed strategies to ensure biocompatibility success from an organizational standpoint. In this second article of the series, he discusses some of the ways to ensure biocompatibility study successes and how to minimize risks.