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.

Spotlight on Morphosis Architects’ Kerenza Harris: Teaching the Value of Parametrics from Concept to Fabrication

By Akio

Perot Museum of Nature and Science in Dallas

 

Morphosis ArchitectsFounded in 1972, Morphosis took its name from the Greek word meaning “to form or be in formation.” While the name alludes to the firm’s “dynamic and evolving practice,” today it might also apply to its innovative use of parametric design tools.

Since joining the firm in 2008, Kerenza Harris has been a key part of Morphosis’ development and integration of these new technologies into design work.

Today, she is helping Morphosis to develop automation systems and parametric tools that can be integrated from the earliest concept design stages through fabrication.

Raising Expectations

Owners, fabricators, and contractors are expecting highly specific information earlier than ever. “It is a bit of a challenge because it forces us to have more complex models earlier on,” Harris notes.

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Click to tweet: “Higher expectations from
owners require more complex models earlier”

In addition, some owners are beginning to expect highly sophisticated models as a baseline for design presentations. While Harris notes that modeling makes it easier than ever to show owners precisely how a project will work, it is creating new expectations about the designer-owner relationship.

Lost in Translation

Embedding such sophistication into models so early can also prove challenging later in the process—should the model need to translated into another format.

“Every time we need to communicate with someone, be it a contractor, fabricator or client, there has to be a phase of translation,” Harris explains.

When this translation occurs, there is always the risk that embedded information could be lost in the shuffle. By bringing contractors and consultants onto the same software and encouraging closer collaboration, such shuffles can be reduced.

The Intelligence of Parametric Design

Having detailed information from the earliest stages is the beauty of parametric design, Harris notes. Using one program from the first line creates an intelligent model with a history.

“We go from simple geometry; a line, a surface, a plane, a solid, to architecture; a room, a building, a door, a window. As we move forward, the window, for example, becomes embedded with additional information: it has a certain size and uniform specification,” Harris says. “As the idea becomes more cemented, it becomes architecture.”

Tweet: #ParametricDesign turns simple geometry into #architecture. @Dassault3DS @M0rphosis #AEC #BIM http://ctt.ec/4v3PB+

Click to tweet: “#ParametricDesign turns
simple geometry into #architecture.”

Along the way, models are imbued with an “intelligence” that can be linked to methods of fabrication, specific materials, assembly processes and so forth. This can prove especially valuable, Harris notes, when changes are necessary.

When information is imperfect or incomplete, it is possible to embed new information into the model without breaking down the entire system.

The Tools Make the Design

Tools such as CATIA have given Harris an edge in explaining the need for specificity to the students she taught in her former position at Texas Tech University, as well as in her lectures today.

Such software allows students to begin working with simple forms and shapes, and then develop those shapes into complex projects with specific materials and systems.

“We then have a model that has history, which allows us to add information without having to start over,” she points out. Having the right tools in the classroom also has helped Harris to emphasize the importance to students of moving from the “big idea” to the materiality of the future assembly.

“The idea has to be complete and you have to use these tools to develop it and make it a reality,” Harris says. She adds, “That’s how we’re able to have a lot of our projects built in the end: because we are very conscious of the materials and assemblies and reality of what these things are. If that can work with the big idea, that’s perfect for us.”

A Big Idea Realized

AIA seems to agree with Harris’ philosophy. Morphosis Architects won the AIA 2014 BIM Award in the categories of Stellar Architecture Using BIM and Delivery Process Innovation for its work on the Perot Museum of Nature and Science in Dallas.

Perot Museum of Nature and Science in Dallas. Photo credit: Roland HalbePerot Museum of Nature and Science in Dallas. Photo credit: Roland Halbe

Morphosis used parametrics in creating the museum’s façade, which is comprised of pre-cast concrete modules that are repeated and reorganized to form a highly complex geometrical pattern.

The software enabled the team to achieve an effect that appears random and unpredictable, but in actuality emerges from a rationalized, pre-fabricated system allowing for a more efficient construction and installation process.

The AIA jury noted that the project stood out “by how it leveraged BIM not just in design but in the shop drawing process, and in the fabrication and installation they achieved things in a time that would have been unimaginable otherwise. BIM assisted in fabrication, documentation, and implementation. The submitter had a willingness to share their digital files to better improve the project.”

In its submission, the project team revealed that the museum’s success depended on this integrated process. The accuracy of the early design allowed the team to share highly detailed 3D models with the owner, fabricators, and contractors who used them to develop shop drawings and even a framework for installation.

The result: a world-class museum delivered on budget and ahead of schedule.

3DEXPERIENCE Forum 2014

Kerenza Harris is a featured speaker along with Becher Neme at the upcoming 3DEXPERIENCE Forum in Las Vegas, November 11-12, 2014.

Learn more or register for this event.

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Related Resources

Morphosis Architects

Watch an 8-minute demo of the Dassault Systèmes Industry Solution Experience Façade Design for Fabrication

Façade Design for Fabrication Industry Solution Experience

3DEXPERIENCE Forum Las Vegas, November 11-12, 2014

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FDA’s Unique Device Identifier: 4 Steps To Successful Implementation for Medical Device Companies

By Jennifer

The Unique Device Identifier (UDI) for medical devices was introduced by the United States Food and Drug Administration (FDA) in 2007 to improve medical device traceability and performance.  FDA published the UDI final rule detailing the regulatory requirements in September 2013 and provided further guidance in July 2014. Class III medical devices were required to have UDI compliance in September 2014, and deadlines for Class II and I will be in 2015 and 2018, respectively. It is likely that global adoption of FDA unique device identification, or similar regulatory requirements, will occur. UDI implementation may seem to be yet another “regulatory hoop” that medical device companies must support, however in our view it is an opportunity to improve the patient experience by providing a more holistic approach to launching and tracking medical technologies pre-market and post-market launch.

Unique Device Identifier

Figure 1. Unique Device Identifier Shown in the Context of a Product Label. Source: UDI Conference 2012 Jay Crowley, Senior Advisor for Patient Safety, FDA. (Click to enlarge)

Follow our 4 key steps for UDI compliance, complete with the challenges you’ll face as well as solutions provided by the Licensed to Cure for Medical Devices industry solution experience powered by the Dassault Systèmes 3DEXPERIENCE© platform.

  1. Prepare the device identification (DI, see Figures 1 and 2) records by acquiring all the relevant data from various sources and documents. Data for the DI include elements like Device Identifier Type/Code, Make/Model, Brand/Trade Name, and Clinically Relevant Size. The data needs to be validated by departmental stakeholders to ensure that the information represents the final released product for the UDI submission.
    Challenges: Data aggregation may be difficult because it is in different forms, and medical device companies need to collect between 70 and 120 different product attributes to meet regulatory requirements. Of these data attributes, 55 DI attributes are submitted to the FDA GUDID.
    Solutions: Manage DI records collection as a project, using an enterprise process workflow to assign tasks to different parties to provide information from across your organization.
  2. Submit and Publish the DI record to the U.S. FDA global unique device identifier database (GUDID). After filling out the FDA forms and submitting to the FDA GUDID, the Regulatory Manager must wait for the acknowledgement of acceptance. If the submission is not accepted, the issues identified are addressed and the DI resubmitted to the FDA GUDID.
    Challenges: The UDI labeling process, which is already lengthy due to data aggregation, formatting, and coordination of cross-functional teams, is lengthened further by this process. Waiting for acknowledgement, and the possibility of needing to resubmit, adds to time pressures to meet deadlines and to coordinate with the product launch.
    Solutions: Improve project management efficiency by maintaining a “single version of the truth” medical device database. Review and approve DI record using electronic signatures to stay compliant. Receive and record acknowledgement from FDA GUDID when a submission is successful or record rejection notices for invalid DI record submission.
  3. Maintain and Monitor the device status throughout the product lifecycle to keep the U.S. FDA product registration and GUDID up-to-date.
    Challenges: Ensuring total traceability of the UDI implementation.
    Solutions: Store all device attributes (based on a pre-formatted data model aligned with U.S. FDA guidelines) in one enterprise medical device database (device information, packaging and secondary information, and device characteristics).
  4. Bridge Information between medical device reports and DI records to build root cause analysis of data and any issues. The Regulatory Manager needs to associate device/patient issues with identified product to accelerate post-market surveillance activities (for example, adverse event reporting/aggregation, medical device recalls, tracking and tracing, and patient notification).
    Challenges: Growth of medical device companies, sometimes through acquisition, make it difficult to track and manage uniformity, accuracy, semantic persistence, stewardship, and accountability of label identifiers, as well as other device data elements needed for regulatory compliance.
    Solutions: Increase information sharing throughout the enterprise using a centralized repository of DI records. For root cause analysis, perform “where used” analysis to highlight relationships with other databases, such as complaints (internal/external).
Unique Device Identification

Figure 2. Unique Device Identification (UDI) required by the FDA for Medical Devices. The UDI is designed for electronic identification (bar code) and to provide information to consumers (bottom numerical region). In the numeric region, the left part (Global Trade Item Number or GTIN) is a static code for a product and is also referred to as the Device Identifier (also DI). The remainder of the code on the right, the Production Identifier (PI), is more dynamic and is comprised of the expiration date, lot number, and serial number. (Click to enlarge)

Medical device companies face many challenges in meeting the FDA UDI requirements. Dassault Systèmes has a long history in the Medical Device industry, helping leaders create and launch breakthrough innovations. For Class I, II, and III devices, from small organizations to global enterprises integrated with suppliers, our solutions help companies accelerate innovation to market safely, more quickly, at a lower cost while maintaining quality and reducing regulatory risk.

Listen to a recent webinar featuring former-FDA and UDI regulation author, Jay Crowley and partner Kalypso by clicking here.

See Dassault Systèmes’ life sciences solutions page and the Device Regulatory Excellence solution white paper for more details.



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