Designing for the Medical Device Industry: Holistic Solutions

By Helene

This post originally appeared at Core77.

A Multi-Faceted Approach

Bringing a consumer product to market is a challenge in and of itself—taking an idea through concept development, business analysis, beta testing, product launch, and beyond. Add the FDA (Food & Drug Administration) to the mix, and it’s a whole ‘nother story. This is the challenge faced by medical device and product firms, which not only have to make a fully functioning, well-designed product but also have to put it through several rounds of rigorous testing by the FDA and other regulatory bodies.

The AliveCor heart monitor, designed by Karten Design.

“They’re parameters. They don’t stop you from doing anything, but they do make you do it in a way that you, as a user, would probably think is a good thing,” says Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica,

an FDA-registered product development firm with an exclusive focus on medical products. On any given day, Ximedica is running 40 individual programs, overseeing the steps required to bring these products to market. “We don’t do anything that isn’t a FDA-regulated product,” says Petrie.

The timelines for these projects can run anywhere between two to six years. While time-to-market is not the primary driver, finding ways to close that gap can make a big difference in profitability. For companies like Ximedica and HS Design, closing that gap meant becoming International Organization for Standardization (ISO) 13485 certified. “There are so many regulatory and quality metrics that had to be put in place to satisfy those requirements that it made us a better and stronger company,” explains Tor Alden, Principal and CEO at HS Design (HSD). “It also put us to a level where we couldn’t just accept any client. We had to become more sophisticated as far as who our clients were and how we could say no or reach a point of compliancy.” By building those regulations into the design process, these companies are able to anticipate and plan for any potential timely obstacles from the get-go.

As the products become increasingly complex, so do the regulations around how they’re developed. Traceability of every decision is required for ISO and FDA compliance, ensuring that medical device firms have a standardized quality management process that they follow and document every step of the product’s development. Depending on the type of product, specialists are often brought in to advise different aspects of that process. “There are so many parts to the puzzle,” says Petrie. “We have a hundred and forty people, but we still need specialists all over the place. We have regulatory people on staff, but we also bring in other pieces that we need. While all the people we have in the building are experts in medical device development, when we need someone to develop some optics, we go outside for that. It’s very collaborative because nobody can do it all by themselves.”

As an FDA-registered developer and contract manufacturer, Ximedica takes products all the way through to clinical trials—a part of the process that comes with its own set of requirements all its own. Even a product as benign as a toothbrush, for example, calls for regulations under HIPPA (Health Insurance Privacy and Accountability Act) if it is being tested by people over the age of 65, under 18, or those living with certain medical conditions. Being able to connect these requisitions to product features in the beginning would allow a project manager to track deliverables and foresee any hurdles before the final design goes to Verification and Validation.

Concept design of a smartwatch

Companies like Dassault Systèmes hope to offer a holistic approach to these problems. Similar to how Ximedica has positioned themselves as the one-stop-shop for all of the components needed to bring a medical product to market, Dassault Systèmes’ Ideation & Concept Design for Medical Device creates a space for designers, marketers, specialists, and collaborators to bring an idea through all the phases of the design process. Powered by their 3DEXPERIENCE® platform, Ideation & Concept Design for Medical Device brings together automated market listening, 3D-drawing to 3D-design integration, traceability, and project management together in one program—in the cloud.

“It’s very challenging to get a medical product to market in less than two years,” explains Alden. “A lot of it has to do with how challenging it is from the FDA standpoint and getting it through the regulatory bodies, but a lot of it is making sure that everybody is working with the same sheet music. Most important is to capture the user needs upfront and translate them into quantifiable attributes.  Additionally we need to combine these user needs with the technical issues into a product requirement specification.  Managing all these aspects of a project, understanding all the players, and the regulatory milestones is vital to shortening the time to market.”

Check out Beyond the design of the Medical Device to dig deeper into this topic and access the “Ideation & Concept Design for Medical Device” information kit here, over on Dassault Systèmes’ site: Ideation & concept design for medical device.

Foamy Headphones and Smelly Clothes: Designing for the Second Moment of Truth

By Estelle

This post originally appeared at Core 77

High tech products

News about a bad product experience travels quickly. Maybe it’s because of the fact, according to a white paper “Designing for the User Experience,” that five times as many people will tell a friend about a bad experience than a good one, or that social media makes it easier than ever to share that negative message, but news of design shortcomings and failures spread fast.

If I’m buying a pair of headphones and the sound is good, but they’re not comfortable, they’re too small for my head, they are too foamy… I’m not going to have a good Second Moment of Truth with that,” explains Stuart Karten, Principal and Founder of Karten Design.

The same goes for a bottle of laundry detergent you may have purchased for its swanky packaging: if your clothes don’t come out smelling clean, you probably won’t buy it again. That Second Moment of Truth (SMOT) often relies on the user experience, what happens when a consumer actually uses the product. As more and more of those products move towards the digital space, that experience comes down to a digital interface, the intuitiveness of those interactions and ease of use. Karten elaborates:

In general, there are multiple trends that are happening in the consumer electronics arena. One is that things are becoming rectangular boxes with user interfaces. The “stickiness” and the appeal and the connection are moving into the digital space. That puts a lot of challenge on—not only the overall form factor of the product on that first level—but the second level of that digital engagement”.

There are other challenges as well when it comes to designing high-tech consumer electronics. “With High-Tech, the technology is usually brand new, so this thing that you are designing is actually morphing as you move down the development cycle because, as time is changing, the technology is advancing,” explains Rob Brady, CEO and Design Director at ROBRADY, which focuses on consumer, industrial, marine and medical products.

Both Karten and Brady agree that designing for that second level requires a user-centric approach, spending time with the target audience to anticipate and better meet their needs. For electronics and other high-tech goods, that means understanding the incentives behind why a consumer would want this product and the motivation behind their purchases. “People make a conscious decision that they want a new pair of headphones, a new laptop,” says Karten. “They want it to define who they are and the person they want to be.”

Watches rendering

Designing with a broadly aspirational approach often means putting a series of virtual prototypes in front of focus groups, simulating interaction and providing a realistic rendering that can then be iterated upon before even printing out a physical prototype. Once the limits of virtual prototyping have been reached, focus groups can be brought in and products are placed in their hands. As these products move into the digital space, however, so do those focus groups and companies like Dassault Systèmes are creating solutions that virtually emulate the product development process from coming up with a concept to testing it in a online retail or working setting.

Ideation & Concept Design

You build a model and you test it. You do an alpha and you test it. You do a beta and you test it. You prototype early and often,” says Brady. “At the end of the day, it’s all about humans interacting with products and designers making these different products approachable and accessible.”

Do not miss the new edition of MADEin3D contest “Cup of IoT”, featuring the theme of Internet of Things! Register to the MadeIn3D community to enter the contest now! Also, you will want to check out our white paper titled “Designing the User Experience”.

Enter the Cup of IoT contest!

Moment of Truth in Designing a Differentiated Product

By Estelle

This post originally appeared at Core 77

Watches

The MP3 player wasn’t a new thing when the iPod came out, nor was the iPhone the first smart phone,” observes John Maeda, Design Partner at Kleiner Perkins Caufield & Byers and former president of the Rhode Island School of Design. “But they were the ones that made you give a damn.”

What Maeda describes in that 2011 Huffington Post article is the First Moment of Truth (FMOT)—that moment when a consumer walks into a store, faced with several comparable products and has to make a decision. They pick up MP3 player one, MP3 player two, hold them in their hands and, in that FMOT, decide which one they will purchase. In a world where many products are relatively similar in terms of technology, price, performance and features, design is that differentiator.

That differentiator is what companies like Karten Design try to create. “How do you get mindshare? How do you stand out? How do you create “sticky” stuff? We use design research,” says Stuart Karten, Principal and Founder of Karten Design, a product innovation firm made up of scientists, sociologists, anthropologists, and designers who go out and spend time with the people for whom they are designing products.

CATIA Natural Sketch

We are trying to understand their habits and ceremonies, so that we can create products that fit in with the way people live their lives, making them easier to adopt,” explains Karten. “Most importantly, we are trying to find unmet needs—common needs that are persistent in people’s lives, but aren’t being satisfied through the current products, or even the product categories that are available on the market. We use unmet needs to drive new ideas.”

For consumer electronics, that means not only identifying a target audience and creating a product for them, but also following through on the promise of what the product does. That second piece, known as the Second Moment of Truth (SMOT), is vital to creating a positive, lasting impression with a consumer. “That’s the gauge that you have to use to make a truly successful consumer product,” shares Karten. “It has to look good to earn that first moment of truth, and then you have to deliver on it with a product that holds meaning and value in a person’s life.”

Watch

To ensure a positive FMOT and SMOT, Karten and his team go back to where they start the ideation process—with people. “Take things and put them in front of users quickly. That design principle is embedded in our company,” says Karten. “We want to get feedback from people earlier and quicker in the design process to find out what stands out, which ideas resonate functionally and emotionally. Go to the people.” Earlier feedback means faster iterations, shortening the timeline it takes to put a product on the shelf.

That process involves creating a series of virtual and physical low fidelity mock-ups, iterating and repeating, increasing the fidelity with each round. Virtual prototypes can give focus groups a very realistic visualization of the final product, saving time and money before moving on to physical prototypes. “Thanks to new technologies such as 3D printing, the iterative design process can now happen very quickly and cost effectively, so it’s taking off a lot of time in the product design process—across the board,” says Arieh Halpern, Life Sciences Industry Business Consultant Director at Dassault Systemes. Dassault Systèmes works to create solutions like *Ideation & Concept Design*, which keeps track of requirements and manages concurrent focus groups, helping shorten the timeline from research to market. “You’re now able to work on the same concept design with your focus groups in real time, do your drawings in real time, and then convert those into 3D prints,” explains Halpern.

Watch

Shortening that timeline makes a huge difference in the field of consumer electronics, where a shorter timeline means putting that product in the hand of focus groups for that FMOT and SMOT that much sooner. In a field where design is the differentiator [PDF], that time can make all the difference in the success of a product. “With a consumer electronic product, you have to create something that somebody wants. You have to steal the show,” says Karten. “That’s the first moment of truth.” If a product doesn’t deliver on that first moment of truth, it might be the last.

Want to create your Connected Object  ? Register to the new edition of  MADEin3D™ contest, “Cup of IOT”, the theme is Internet of Things !

CupofIoTThis time again, we are lucky to have cool sponsors & partners with us to organize this worldwide competition: Withings, Nodesign.net, Prodways, ES Numérique, and CapDigital. The winner’s will thus be nicely rewarded !

Register to the community to enter the contest now!

 



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