Designing for the Medical Device Industry: The Future – Connected Health

By Helene
Initially posted by CORE77

With the explosion of wearable technology and legislation like the Affordable Care Act, the medical product industry is rapidly evolving. Healthcare is seeing unprecedented changes, creating new opportunities for devices that connect consumers and doctors to information faster, easier, and more efficiently.

“It’s coming to a point where there are just amazing breakthroughs every day,” says Tor Alden, Principal and CEO at HS Design (HSD), where he has been directly involved in medical design for over 14 years. “[Technologists] are innovating and changing the landscape of how healthcare is going to be done to the point where we’re not going to recognize it in the next three or four years from where it is now.” It’s a changing landscape that has caught the eye of many innovative startups, who now make up half of HSD’s client list.

These new products have amazing technology, but it needs to be humanized and centered on user needs to be successful.”

HSD is positioning itself to be a bridge connecting the medical and healthcare startups with the investment banker communities. Alden predicts that if the growth continues at this rate, that number could be closer to 80% in the next few years.

The AliveCor heart monitor. Designed by Karten Design.

One of the factors opening the door for innovation in the medical device industry is the Affordable Care Act. As requirements roll out for health care providers, there is an increasing need for new tools and products that ensure patient compliance. Take a typical hip replacement, for example: Under the Affordable Care Act, if a doctor or hospital is not tracking the compliance and rehabilitation of that patient and they return within a year with no improvement, the hospital owes money to the government. There’s a financial incentive to make sure patients get better and, therefore, to track and evaluate their progress. This could spur invention around hip replacements—possibly leading to one with a chip (i.e., embedded UDI) to track rehabilitation or remind patients to get complete their physical therapy exercises.

“The Affordable Care Act is a great opportunity for the design community right now. Everybody is trying to figure out how to innovate increase patient compliance and allow caregivers tools to manage the healthcare services,” says Alden. “Between that and the iHealth generation of iPhones, smartphones, iPads, and everybody wanting to have more control over their healthcare knowledge, there’s a huge opportunity for new products.”

In the century of the wearable device, nearly everyone has some type of personal fitness tracker. For the medical device industry, this means a rise in connected health as consumers clamor to track everything from their steps to calories to sleep cycles. With that surge in technology comes an accelerated need for the design and development of interfaces between the technology and the consumer. “This is the most interesting space that a designer could work today. It’s fascinating,” shares Aidan Petrie, Co-Founder and Chief Innovation Officer of Ximedica, a medical product development company headquartered in Rhode Island. “We work between humans and the products they use and make sure that they are more usable, satisfactory and safer.”

Ideation & Concept Design

Despite the incentive for new and better products, the medical device industry remains a difficult niche to break into, due to FDA regulations, enormous amounts of capital required, the need for a high level of specialization, and timelines that span 2–6 years. All these factors contribute to a high failure rate, causing many of these projects to be cancelled before they even reach the prototype stage.

Dassault Systèmes is trying to lower that rate of failure by creating software applications that help these companies better understand and anticipate these challenges from the beginning of a project. The software company released an all-in-one program called Ideation & Concept Design for Medical Device industry solution experience, a cloud-based platform designed specifically to take a team through the entire product development process. From initial ideation and market research to verification and validation, the system tracks deliverables and traceable requirements demanded of the strict FDA and other regulations around this sector. With Ideation & Concept Design for Medical Device, Dassault Systèmes shortens the amount of time it takes to bring a product to market, which is critical in a quickly expanding market where there is no time to waste.

The medical device industry will explode for the next twenty years. It will be the place to be focused as a designer,” says Petrie. “It’s great doing things that change people’s lives, and a product can still look beautiful at the same time.”


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.

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.

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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