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.

Stop Using Digital Duct Tape for Multi-CAD Solutions

By Ron

 “I love Rube Goldberg” by Todd Van Hoosear, used under a Creative Commons 2.0 license.

While pondering the challenge of companies managing multi-cad environments (yes, I know, this is what geeks do…) I couldn’t help but to imagine a Rube Goldberg device. Often, creative and resourceful workarounds (what I like to call “digital duct tape”) are deployed, but the opportunity for improved collaboration and productivity is missed.  The rule of thumb for data management is that as your CAD systems double the complexity quadruples.  In the absence of strategy and planning, data management problems can quickly get out of hand.  The “digital duct tape” can only stretch so far…

Most of us (Rube Goldberg aficionados excluded) do not purposely create complex environments…But there are reasonable explanations as to how companies ended up needing multi-CAD solutions:

  1. Mergers and Acquisitions: Organizational and cultural assimilations require rationalizing and connecting different technologies. Engineering departments especially often have multiple MCAD and ECAD authoring tools in place.
  2. OEM Supplier Relationships: Particularly in automotive and aerospace, suppliers must submit MCAD and ECAD data to an OEM in a prescribed, proprietary format.  Suppliers must have multi-CAD authoring tools on site to do business with multiple OEMs.
  3. Departmental Decisions: Today, global competitiveness demands that all departments collaborate and maximize their intellectual property. Gone are information silos.

The inability of multi-CAD authoring tools to collaborate and share information outside engineering, coupled with the resulting inaccurate Bill of Materials (BOM) potentially is damaging to any company (and your job!).

Transforming a multi-CAD challenge to a multi-CAD opportunity is the business of Dassault Systèmes ENOVIA®.  Companies such as Eaton, 3M and Toshiba use the ENOVIA Multi-CAD solution to increase productivity and gain PLM benefits.

Sign up for a 12 minute pre-recorded seminar and learn how the ENOVIA Multi-CAD solution can help you at http://emailing.3ds.com/dsx/lpv2.jssp?template=LDP14510&refcode=socialmedia.

Building Lifecycle Management Fosters a BIM Level 3 Approach for End-to-End AEC Collaboration [Whitepaper]

By Marty

Industrialization techniques have been commonly used in Manufacturing industries for decades. Now the use of Industrialized Construction in AEC is expanding to help improve planning, design, construction, and assembly for increased sustainability, optimized operations, lower costs, and greater safety.

Whitepaper

With the growing adoption of BIM, companies can further benefit by implementing a Building Lifecycle Management (BLM) system. BLM puts into practice a BIM Level 3 approach that enables a highly efficient Extended Collaboration model based on Product Lifecycle Management (PLM) and Manufacturing industry best practices.

Dassault Systèmes has just published an industry paper proposing an Extended Collaboration model for AEC, based on Manufacturing industry best practices.

Extended Collaboration Model for Design, Construction & OperationsClick to expand

The concepts covered include:

  • How a Design Review process helps connect architects and building product system manufacturers to reduce the number of issues that must be formally clarified by RFIs and submittals during project delivery
  • How Process Simulation can reveal even minor integration errors, illustrate which processes are the most cost- and time-effective, demonstrate how prefabrication will affect a project, and generate highly accurate sequence data
  • How collaborative processes and advanced technologies streamline operations and improve project outcomes, illustrated by examples and client case studies
  • How to unlock BIM data, making it “transactable” across the extended project team, to achieve BIM Level 3
  • The limitations of BIM Level 2 point solutions
  • BLM system benefits, and features of the Dassault Systèmes 3DEXPERIENCE® platform and applications
  • How to approach the implementation of a BLM system

… and more.

Download the paper: “End-to-End Collaboration Enabled by BIM Level 3: An Industry Approach Based on Best Practices from Manufacturing”

Tweet: Building Lifecycle Management Fosters #BIM L3 Approach for End-to-End #AEC Collaboration [Whitepaper] @Dassault3ds http://ctt.ec/B9X97+Click to Tweet this article




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