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.

Challenges and Opportunities of Feeding an Expanding, Aging Population

By Catherine

Written by Catherine Bolgar

Food has its fashions, with form and function battling for dominance. Convenience, low-calorie, locavores, organic, functional food, indulgent excesses…what’s next?

Personalized nutrition, nutrition density, immediacy and alternative proteins are some of the key words for the future.

Personalized nutrition

Salad

We’re going to see even more diversity of choices, as well as products aimed at specific population groups, says Gerhard Rechkemmer, president of the Max Rubner Institut, a food and nutrition research organization in Karlsruhe, Germany.

In the future, that will go into what we call personalized nutrition,” he says. “You will have the genetic or metabolic design of a person and provide food for their needs.”

The microbiome—the bacteria in the gut—is even more genetically diverse than the genes in our own bodies. These bacteria “have a metabolism as we do, but it’s something we don’t much understand yet,” says Peter Weber, a medical doctor and nutritionist in Kaiseraugst, Switzerland. “In the future, we will understand better how the different systems in the body interact.”

While the outlines of a prudent diet are known, new research results in adjustments to details like recommended daily requirements for various nutrients. That’s likely to go further, with adjustments based on individuals’ genetic makeup.

Nutrition density

Two rapid changes are affecting our relationship with food that will make nutrition density a key trend in the future. First, our lifestyle has become much more sedentary, even within the past few decades. Second, we are living much longer.

In both cases, we are eating more calories than we need. The result is the explosion in obesity—a 28% increase in adults and 47% increase in children in the past 33 years, with the number of overweight and obese people hitting 2.1 billion in 2013, according to the Global Burden of Disease Study 2013, published in The Lancet.

Yet even though we’re eating too much, we aren’t getting the nutrition we need. “When we talk about nutritional challenges, we typically start off with developing countries because that’s so obvious,” Dr. Weber says. “But in affluent societies we also have micronutrient inadequacies.”

On a global level, about 37% of people have insufficient vitamin D serum levels and only 12% are within the desired range, Dr. Weber says, adding that about 90% of Americans aren’t getting enough vitamin E. The World Health Organization estimates 250 million preschool children lack enough vitamin A, which puts them at risk of blindness.

As people age, their bodies absorb less of the micronutrients in food. The challenge in the future is “how we can make appropriate food which is micronutrient dense, with not too much energy and which tastes good,” Dr. Weber says.

Immediacy

Snacking in the U.S. represents half of all “eating occasions.” While people say they are looking for something healthy for more than half of those snacks, “planning is hard. People are time-stressed. Their lives are hectic,” says Laurie Demeritt, chief executive of The Hartman Group, a food research and consulting firm in Bellevue, Washington.

People prefer to make decisions about food close to the eating occasion, to choose based on their mood at the moment. “They don’t like to plan. They eat on a whim. It changes how we view food,” she says.

As a result, retail formats are adapting to serve people who want to buy something to eat at the last minute, by serving freshly prepared offerings. Food-service operators also are making it possible for people to call in an order that they can run in to pick up. It’s a trend that’s likely to grow.

Twenty or 30 years ago, there were certain places where you could buy food,” Ms. Demeritt says. “Now there are more options for food procurement, and not so much pressure for planning.”

Even though 60% of millennials say they enjoy cooking, they aren’t talking about cooking from scratch, she says. “They want to get a sauce that’s prepared, but they’ll choose the vegetables, for example. They’re looking for the manufacturer to be the sous-chef and still let them have choice and creativity.”

Alternative proteins

As the world population climbs toward an expected peak of nine billion, there’s a question of how people will get enough to eat, especially as people who enter the middle class in developing countries tend to adopt the same kind of meat-heavy, processed diets common to affluent societies.

When the Chinese began to drink more milk, it had an impact on the global milk supply,” Dr. Weber says. “If we have three billion more people to feed in the future, from where should we provide protein? From even better farming? From plants? From artificial proteins that you grow in a lab? These are opportunities and challenges.”

Protein ties into the aging of society as well, because older people need to consume more protein to deal with muscle wasting.

senior woman cutting vegetables on chopping board in kitchen

However, in Europe and the U.S., vegetarian and vegan diets are becoming more popular, says Dr. Rechkemmer of the Max Rubner Institut. India shows that “a vegetarian diet supplies sufficient protein if you have products available. It remains to be seen whether that trend will continue.”

However, in Europe and the U.S., vegetarian and vegan diets are becoming more popular, says Dr. Rechkemmer of the Max Rubner Institut. India shows that “a vegetarian diet supplies sufficient protein if you have products available. It remains to be seen whether that trend will continue.”

For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.



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