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Design for Manufacturing (DFM): Principles, Processes, and Best Practices
What Is Design For Manufacturing (DFM)? Design for Manufacturing (DFM) is the practice of refining product designs so they can be produced reliably and cost-effectively at scale using standard manufacturing methods. For instance, a prototype that works on a 3D printer may not be feasible for mass production with injection moulding. DFM bridges that gap,…
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FDA 510(k) Process Explained: What to Know About Premarket Notification
For companies looking to bring moderate-risk medical devices to market, navigating the FDA’s 510(k) premarket notification process is essential and often complex. This guide breaks down the fundamentals of a 510(k): what it is, how the process works, and the practices that can make or break your submission, but most importantly, it emphasizes the need…
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Commercial Success of Medical Devices By Design
New medical technology that works in a lab has a long road to travel to commercial success. To bridge this gap, designers work alongside researchers to ensure that new devices are not only technically sound but also practical, user-friendly, and commercially successful by design. Safe and Effective Does Not Mean Commercially Successful Medical device founders…
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Medtech Success in 2024: Insights and Strategies
Two recent McKinsey reports offer insights and predictions for medtech success, based on conversations with industry leaders and McKinsey’s research. “What to expect from medtech in 2024” discusses the uneven performance of the medtech industry in 2023, highlighting factors such as revenue growth, product approvals, and investor sentiment. Seven key predictions are made for 2024,…
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Unpacking Bias in Ethnographic Research for Designers
While performing ethnographic research, how can designers minimize bias and ensure the credibility of their findings to inform impactful and inclusive design choices? This article explores the complexities of ethnographic research, in a design context, identifying biases and providing practical strategies to avoid them. What is Ethnography? Ethnography — a qualitative methodology — takes an…
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Precision Tools for Medtech Manufacturing
As the healthcare sector emerges from the pandemic, providers and their medtech manufacturers face a much-changed economic, commercial, and competitive landscape. But one thing remains true – the decision to invest in cutting-edge tools isn’t merely a choice; it’s the cornerstone of successful medtech manufacturing. In this article, we delve into the transformative power of…
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Navigating Medtech Hardware Investments: Key Considerations
As the healthcare sector rebounds from the pandemic, providers and medtech manufacturers encounter a transformed economic landscape. For over a decade, hardware investments consistently outperformed S&P rates. Despite a recent COVID-19-induced slowdown, the medtech hardware sector – resilient and poised for disruption – once again holds significant value for investors. Context and Industry Trends in…
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ISO 13485 Surveillance Audit Results
ISO 13485 audit – ZERO major corrective actions + ZERO minor corrective actions Only one area of improvement was suggested in our recent audit. Our auditor really valued our customized naming conventions as they more accurately describe what we do in each of those areas and suggested that we should ask our certification body…
