Engineering
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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
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 into inputs is where the magic happen [...]
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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
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 to produce their first medical device [...]
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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
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 you must meet as part of the developm [...]
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Design to Innovate — Not Just to Manufacture
by Kevin Larmer Posted Mar 02, 2020 In Engineering, Medical Product Design
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 and those focused on design innovati [...]
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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
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 completed designs? Whether your product is [...]
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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 Jul 23, 2019 In Design Strategy, Engineering, Medical Product Design
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 FDA’s Design Controls. If yours is l [...]
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How GD&T Makes Better Medical Products Possible
by Kevin Larmer Posted May 24, 2019 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 08, 2019 In Engineering, Medical Product Design
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. Even the most meticulous engineering [...]
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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
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 with leather thongs or twine, and today [...]
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Whitepaper; Cleaning, Sterilizing & Disinfecting Medical Devices: How to Specify the Right Chemical Formulation
by Andy Moulds Posted Mar 21, 2019 In Engineering, Medical Product Design
If your medical device is reusable, a method for cleaning and disinfection must be specified by the medical device manufacturer as well as instruction for users on how to clean it. These elements are mandatory whether the product is used in a hospital, laboratory, doctor's office, or at ho [...]
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In-House Tests Reveal Early Problems in Medical Device Designs
by Andy Moulds Posted Mar 06, 2019 In Engineering, Medical Product Design
Within medical device companies, a dedicated team — either quality assurance (QA) or verification and validation (V&V) groups — is often tasked with ensuring that products in development meet a range of standards. Verification involves lab-based prototyping and simulation of products “on t [...]
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Why Common Plastics Are Failing in Hospital Settings
by Andy Moulds Posted Nov 12, 2018 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 tre [...]
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A Medical Device Designer’s Guide to Skin-Related Products
by David Giuntoli Posted Sep 25, 2018 In Engineering, Medical Product Design
The approximate 20 square feet that we call our skin is astonishing at allowing us to move, to control our body temperature, and to survive life's tumbles. Thankfully this exterior organ is very good at repairing itself, but it has limits. These limitations are very specific to us as individuals. Wh [...]
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Prototypes: A Fast Chance to Fail
by Kevin Larmer Posted Aug 28, 2018 In Engineering, Medical Product Design
The return on a prototype is immediate and enduring. Nearly every time I have plucked a fresh prototype out of the box, I have learned something. Usually something important. Something project-saving: The size was wrong, the finish was critical, the button was inaccessible, the device wasn't service [...]
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The Misunderstood Engineering Prototype
by Chris Ross Posted Oct 19, 2016 In Design Strategy, Engineering, Medical Product Design
In developing a new medical device, some start-ups proceed with a high degree of confidence that their core technology engineering prototype should become faithfully transformed into the actual product that will come to market. What they actually have at this point in time is a technical solution [...]
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MindFlow Design is a leading medical product development firm for Medical, Life Sciences, and Consumer Health Companies and is based in Carlsbad, CA. We aspire to introduce powerful, intuitive healthcare technologies to the world.
