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…
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…
Personal bias refers to an individual’s preconceived notions and opinions that can influence their decision-making process. In creative design, personal bias can manifest in a variety of ways, from the selection of colours and typography to the choice of imagery and messaging. While bias is an inherent part of human nature, it is important for…
Medical product development risks exist because medical device development is a complex process. It requires a thorough understanding of the risks involved. In this post, we will take a closer look at the 4 most common physical product development risks and how to mitigate them. We also tap into Cortex Design’s Founder and Chief Product…
When developing new products, most founders focus on the impact of the technology. They recognize it needs to be “usable” for users and that gets stated as a priority. Through the development and commercialization process, the user experience is often de-prioritized due to other priorities such as human resources, budget, or time constraints and/or a…
In a design agency, clients come up with ideas every day. Ideas that are usually created when someone, somewhere, experiences a problem and asked themselves if there was a way to prevent or avoid that problem in the future. That’s where an agency comes in. An idea is not a solution, but it is…
Medical Devices are moving into the home and it is putting patients at the center of their own healthcare journey. Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use…
Product design for medical devices or consumer health tech can be a daunting — and treacherous — climb. Here’s how road mapping can minimize the risk! Suppose there’s a medical startup developing a game-changing medical device. After a seed round, the company budgets $1.2 million for product development over 12 months. Their team debates whether…