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.

World-Changing Dreamer: Ismael Cendejas

By Aurelien

IFWEFollowing our previous blog post on IF WE Challenge third winner Andjelic Zoran, the turn is now to our second prize winner Ismael Cendejas. Ismael is coming from Mexico, but has recently studied in University of Victoria, BC, Canada. His winning IF WE Dream was: “IF WE design more exoskeletons we can help more people with different capacity”.

As a matter of fact, Ismael is working on two projects in this domain:

I have two projects about Exoskeletons. The first is about the Design of an Exoskeleton for training people with Parkinson’s Disease, which is part of a thesis of a bachelor. The second one is a Design and Matlab simulation of a portable exoskeleton for hand rehabilitation. [...] The most critical engineering discipline in these projects I think is Systems Engineering because all the diseases and patients are different, in that way they need to be treated personally, implying the necessity to develop a program for each one.

Ismael was kind enough to share the following pictures with us :)

Ismael has been using CATIA and SIMULIA for his project. As a winner of the second prize, we’re happy to provide Ismael with a high performance laptop (shown above) coming with 3DS software, thus adding our small contribution to this project with a great social impact potential.

Keep up the good work, Ismael!  :D

 

How Social Innovation turns into Mobility for all

By Jacques

Last week I was at the French startup event LeWeb’12 to get some fresh ideas about digital marketing trends on the startup scene. The theme of this year was the IoT aka the “Internet of Things”, so you could find many connected devices : smartphones, thermostats, watches, drones, headsets, weight or blood trackers that were all mobile and connected things. So why not connect these geeky devices to more familiar transportation & mobility products? IF WE connect internet and transportation, can it offer innovative and profitable mobility concepts?

I was there in my reflexions when I saw the Renault booth at LeWeb and just decided to chat with them to share ideas. And since I had my smartphone with me, I used it to record this impromptu one shot video, so pardon its low quality.

YouTube Preview Image

Getting people back to work thanks to the Mobility community

I met with Florent d’Yvoire, who is project manager on the Renault-MOBILIZ Social Business project to know more about mobility innovation. Our main discussion was about the Renault-MOBILIZ which I found very innovative but not on technology as we usually expect, but more on the business side: This project was born at the Corporate Social Responsibility department of Renault with a vision: looking for sustainable ways to help the poorest benefit from an affordable mobility, so that they can find work and get out of poverty. Beyond that, the innovation is also in the business model that is inspired by the microcredit concept developed by Muhammad Yunus so that it can ensure the financial viability of the project.

In this context the Renault-MOBILIZ program is looking for more connections within the transportation and mobility community of professionals: they are looking for partnerships with entreprises and citizens on providing products, services, and assistance in getting driver’s licenses. Dassault Systèmes can certainly help with its communication to transportation & mobility professionals. More to come on this…

A car-sharing pilot with electric cars

Renault also launched Twizyway, an innovative car-sharing concept in the Paris area with 50 Twizy. These 100% battery-driven cars are beautiful, fun and safe to drive. They are available all day and are tracked and booked via smartphone apps. People use these cars then leave them in the location of their convenience to ensure maximum flexibility for drivers. Customers just scan a QR Code on the windshield and go. So this is quite similar to the Autolib project deployed near there in Paris, but with less constraints at first glance.

Digital apps on the dashboard of your car

The final topic presented by Renault was the second edition of their “call for apps” that will be installed on the dashboard of future cars in a tablet called R-Link. New Zoe and Clio models will benefit from them , Renault was there to call for startups willing to develop new services on their infrastructure.

Renault’s motto is “Drive the change”, now you can see why!  What about you, how would you match internet and transportation yourself? Do you see the digitalization of the world as an opportunity for new mobilities?

Thanks for posting your view in the “comments” field below

Jacques

 

Jacques Bidault is Industry Marketing Director, Transportation and Mobility at Dassault Systèmes

 

 



Page 1 of 512345
3ds.com

Beyond PLM (Product Lifecycle Management), Dassault Systèmes, the 3D Experience Company, provides business and people with virtual universes to imagine sustainable innovations. 3DSWYM, 3D VIA, CATIA, DELMIA, ENOVIA, EXALEAD, NETVIBES, SIMULIA and SOLIDWORKS are registered trademarks of Dassault Systèmes or its subsidiaries in the US and/or other countries.