Commercialization can mean different things depending on where you are in the journey. Ultimately, medical device commercialization is about taking something proven to work and turning it into a product that meets user needs, can be manufactured at scale, and makes business sense. 1. Build a Reliable Benchtop Prototype Before You Outsource If you’re still…
There are Design Controls, and then there are Human-Centered Design Controls. Both fulfill the baseline regulatory and risk management requirements necessary to prove a device is safe and effective. The difference? A human-centred approach elevates standard ‘user needs’ beyond basic compliance, ensuring the final product truly resonates with and optimizes the experience for the people…
What Is Medical Device Prototyping and How Is It Different From Non-Medical Devices? Medical device prototyping is the process of turning a scientific idea into a tangible product and progressively refining it through iterative development. While the process is similar to that used for non-medical devices, medical device prototyping has an additional emphasis demonstrating not…
Design reviews are a mandatory part of medical device development and are often mistakenly treated as a compliance checkbox. When done properly, however, they can become a meaningful competitive advantage. This article explains why medical device design reviews matter and how to conduct them effectively—from what a design review is and who should be involved,…
Project management (PM) is crucial in medical device development because the stakes are uniquely high. You’re not just managing scope and timeline, but also navigating strict regulatory standards, user safety, technical complexity, and market viability. In this article, we break down what makes MedTech project management different from other industries, what a medical device PM…
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,…
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…
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…
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,…
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…
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…
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…
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…
DFM is a critical aspect of the product development process. Targeting considerations of feasibility and cost-effectiveness of the product during production, DFM is a complex process. It requires careful consideration of numerous factors and a delicate balancing of often competing priorities and constraints. Unfortunately, some important elements of DFM are often overlooked, leading to problems…
Outsourced Manufacturing “Welcome to the Design to Product Podcast! In this interview episode, we talked to Dylan Horvath about saving cost and time with outsourced manufacturing. Dylan Horvath is the founder and president of Cortex Design, a product design + manufacturing firm. Dylan talked about common mistakes of product builders and innovators that drive up timelines and…