Medical Product Design

4 Advantages of Working With One Medical Device Development Partner From Concept to Completion

by Hank Kohl Posted Nov 15, 2021 In Medical Product Design

The entire healthcare industry changed in response to Obamacare and subsequent value-based healthcare initiatives. It’s no longer about reactive care and treating a patient with corrective measures once they’re already sick. Instead, preventative care has become paramount. For medical device [...]

Whitepaper: How to Better Source User & Safety Needs for Your Device’s Traceability Matrix

by Andy Moulds Posted Oct 27, 2021 In Medical Product Design

Creating a comprehensive traceability matrix hinges on sourcing accurate user, safety, science, and technology needs related to your medical device. Like most companies, your firm is probably science-and/or technology-driven. You’re comfortable documenting these needs in your matrix. But use [...]

Does Your Medical Device Need Design Controls? Here’s What You Need to Know.

by Chris Ross Posted Oct 04, 2021 In Design Strategy, Medical Product Design

New medical devices offer fresh opportunities for your company to improve health outcomes, push the boundaries of medical innovation, and grow your business. Who wouldn’t be excited about that? But medical devices also carry varying levels of risk that must be carefully managed. As the product [...]

Your Medical Device’s User Interface Specification Is More Powerful Than You Think

by Chris Ross Posted Sep 21, 2021 In Medical Product Design, User Insights & Design Research

The FDA requires user interface specifications for medical devices. But your user interface specification can and should be more than a requirement or regulatory box to check. After all, a robust specification establishes design specs, which inform the experience users ultimately have wi [...]

5 Tips for Medical Device Companies to Design Home-Use Products Right

by Chris Ross Posted Sep 15, 2021 In Healthcare Trends, Medical Product Design

In the past, medical device design companies and consumer product companies didn’t often intersect. Medical product developers were almost exclusively concerned with FDA regulations, while consumer product creators focused on lifestyle needs. But that was then. Today, two trends are causing the [...]

MindFlow Design of Carlsbad, Cal. Being Acquired by Medical Device Manufacturer MPE

by Chris Ross Posted Sep 10, 2021 In Medical Product Design

Design Firm to Enhance MPE’s Concept to Completion Model

CARLSBAD, CALIF. (PRWEB) SEPTEMBER 08, 2021

Breaking Down the Verification and Validation Processes for Medical Devices

by David Giuntoli Posted Aug 23, 2021 In Engineering, Medical Product Design

Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design inputs. Why do design inputs matter? Because if you don’t satisfy your design inputs, your product w [...]

What Happens to Your Medical Device When the FDA’s Emergency Use Authorization Ends?

by Carmen Cumming Posted Jul 23, 2021 In Healthcare Trends, Medical Product Design

Throughout the COVID-19 pandemic, the FDA has issued hundreds of Emergency Use Authorizations (EUAs) to medical devices. EUAs allowed each of these products to fast track their approval in order to serve the public during a tumultuous, unprecedented, and sometimes dangerous time. But now that COV [...]

Human Factors Engineering vs. UX: Are They Really All That Different?

by Chris Ross Posted Jul 20, 2021 In Design Strategy, Human Factors & Usability Testing, Medical Product Design

From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a safe, straightforward, effective, and delightful way. But the technical definitions of these terms can v [...]

6 Ways a Consumer Health Product Can Improve Quality of Life

by Chris Ross Posted Jul 12, 2021 In Design Strategy, Medical Product Design

Consumer health products are simp [...]

Understanding Finite Element Analysis and Its Benefits for Your Medical Device

by David Giuntoli Posted Jun 25, 2021 In Engineering, Medical Product Design

There are products from our grandparents’ and even great-grandparents’ eras that are still in use today. In their time, technology didn’t advance nearly as quickly, so products were expected to last a lifetime — and they were built accordingly. Everything was "built to last". Today’s de [...]

The First Steps to Medical Device Risk Management: Selecting Your Team and Identifying Hazards

by Andy Moulds Posted Jun 11, 2021 In Medical Product Design

Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes increasingly stringent FDA requirements. And what happens if you don’t properly account for risk in the ea [...]

Why Your Medical Device Company Should Develop Accessible Products — and How

by Carmen Cumming Posted Jun 01, 2021 In Healthcare Trends, Medical Product Design

Medical device designers often overlook accessibility when creating products. Getting a medical device to market is complex, costly, and time consuming — there’s simply no bandwidth to consider accessibility in the midst of an already rigorous process. What’s more, many people think accessi [...]

The FDA Updates You Need to Consider for Your Next-Generation Medical Device

by Andy Moulds Posted May 20, 2021 In Design Strategy, Medical Product Design

[vc_row][vc_column][vc_column_text css=".vc_custom_1621633944440{margin-bottom: 0px !important;}"]Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason. All that to say, as you’re developing a next-gen [...]

Why Common Plastics Are Failing in Hospital Settings

by Andy Moulds Posted Apr 28, 2021 In Medical Product Design

Patient safety and reducing hospital stays is the priority for healthcare institutions and one of the focus areas is preventing patients from getting HAIs (Healthcare-associated infections) during their stay. These HAIs are the responsibility of the institution and have to be treated and paid for by [...]