Engineering
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These Are the Contents of a Proper Product Requirements Document
by MPE Team Member Posted Aug 08, 2023 In Design Strategy, Downloads, Engineering
Technically, the purpose of the FDA-required product requirements document (PRD) is twofold:
- To define the standards the end product must meet to satisfy your company’s inte [...]
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Breaking Down the Verification and Validation Processes for Medical Devices
by MPE Team Member Posted Jun 06, 2023 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text css=".vc_custom_1687563294992{margin-bottom: 0px !important;}"]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 inpu [...]
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Understanding Finite Element Analysis and Its Benefits for Your Medical Device
by David Giuntoli Posted Jun 25, 2021 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]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. Everythin [...]
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How GD&T Makes Better Medical Products Possible
by David Giuntoli Posted Apr 24, 2021 In Engineering, Medical Product Design
Geometric dimensioning and tolerancing (GD&T) is intimidating even for trained engineers to pick up. GD&T has a set of vocabulary that is initially impenetrable and throws out a lot of traditional drawing practices. Once you get past all the new terms and how they interact with one anothe [...]
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Save Time & Money by Implementing GD&T in Your Medical Product Design
by David Giuntoli Posted Apr 15, 2021 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]No matter how precise the manufacturing process, there will inevitably be some degree of variation in the components that make up your medical product. All the parts that comprise the finished device will be minutely different from one another and from the spec. [...]
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Why Common Plastics Are Failing in Hospital Settings
by Andy Moulds Posted Dec 04, 2020 In Engineering, 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 [...]
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How to Design and Produce Injection Molded Parts For Your Medical Device
by David Giuntoli Posted Nov 25, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]From toys and automotive parts to cell phones and mechanical components, injection molded parts can be found in many of the objects we interact with each day. In fact, it would be difficult to picture our world without them. And the same goes for medical device [...]
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Tips for Sourcing Commercial Off-The-Shelf Parts for Your Medical Device
by Carmen Cumming Posted Oct 14, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]Medical devices are often entirely custom, but what happens when you don't want to get into the business of making a custom display? Or a computer? These electronic devices have to conform to certain standards for the consumer market, but what if they are going [...]
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Designing the Right Medical Product Starts with Defining User Needs. Here’s How to Do it Right.
by Andy Moulds Posted Aug 26, 2020 In Design Strategy, Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDAâ [...]
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Bridge the Gap Between User Needs & Unknown Design Inputs with Qualification Testing
by Shane Fedon Posted Jun 26, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]The first step in building a medical device is to identify the full range of user needs your product will meet. Only then can you begin actually designing a product by translating those needs into a set of specifications (or inputs). The act of translating needs [...]
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Failsafe Your Medical Device Development Process with a Comprehensive Project Plan
by Andy Moulds Posted Jun 09, 2020 In Design Strategy, Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps along the path to a new product launch. Companies that are attempting [...]
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Medical Device Development Is Complex — But It Doesn’t Have to Be Difficult
by David Giuntoli Posted May 26, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]Most medical devices involve some degree of complexity. Of course, that’s inherently true of high-risk and technologically sophisticated devices. But even the most straightforward medical device isn’t so straightforward when you consider the FDA requirements [...]
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Design to Innovate — Not Just to Manufacture
by Kevin Larmer Posted Mar 02, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]The development of medical devices can follow many different paths depending on a myriad of inputs: new technology, cost, market adoption, etc.  At Mindflow, we see many projects that focus on two of these paths: products focused on efficiency in manufacturing [...]
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After the Designs are Done: Why Your Medical Device Needs an Agency’s Support Phase
by John Salisbury Posted Jan 02, 2020 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]If you’re considering partnering with an agency to help you realize your vision for a new medical device, you already know you need outside expertise for the design phase of your project. But what happens after everyone signs off on a final version of the comp [...]
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Three Approaches (& Consequences) of Affixing a Medical Device to Skin
by David Giuntoli Posted Mar 28, 2019 In Engineering, Medical Product Design
[vc_row][vc_column][vc_column_text]There are three popular methods to hold a medical device or treatment onto the human body: tie it on, stick it on or suction it on. The first method was developed by our prehistoric grandparents to hold remedies of flora and what-have-you by tying it in place wi [...]
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