How Medicine Makes Sense of Big Data

By Catherine

Written by Catherine Bolgar*

Big data for Medical

Big data is a game-changer for medical research. The ability to analyze vast sets of information, thanks to bigger and faster computers, is helping researchers to understand diseases, tease out genetic factors and spot patterns.

More researchers are looking at big data and understanding how we can utilize [it] in a better manner,” says Ervin Sejdic, assistant professor of electrical and computer engineering at the University of Pittsburgh, U.S., and founder of its Innovative Medical Engineering Developments lab.

In the past, clinicians would get data from patients and hold it up to metrics to try to see something by looking among different patient groups. “What they’re doing is flushing out the details. But the devil lies in the details,” Dr. Sejdic says. “The details are where we start understanding things. What’s really shifting in medicine is the fact that, yes, there is data, but let’s look at whole data sets.”

At the same time, better and smaller electronics, from smartphones to sensors you can wear, can compile more information at a detailed level and over bigger populations. “Researchers are looking at the interactions between different physiological systems. Sometimes these interactions break down in people with various diseases. Sometimes you have to look at the level of a minute, or an hour, or a day,” Dr. Sejdic says. “What big data is going to enable us to do is finally look at a human system as a system, rather than as individual components put together.”

Big data also is helping doctors and researchers to view diseases in shades of gray, rather than with a purely black-and-white outlook.

In the past, diseases were viewed in a simplistic way: a person is healthy or a person has disease. We would get specific information about the two states and compare the difference,” says Sergei Krivov, research fellow at the University of Leeds, U.K., who recently published research on the monitoring of kidney-transplant patients using big data techniques.

With transplants, he says, “There are two outcomes: perfect or problems. We are trying to find a single parameter to describe where you are between these two stages and what is the prognosis.” Based on the indicator, doctors can decide at an earlier stage whether to intervene into the process.

What I would like to see in the future is the following picture,” Dr. Krivov says. “A sizable part of the population frequently gives blood for analysis, for example during regular visits to their doctors. This would go to a data center. Based on this data for five or 10 years, we could determine indicators describing the degree of progression or the likelihood to occur for different diseases. We will give back this information as numbers, which is easy to interpret. This, in turn, will encourage patients to participate.”

One indicator patients might get with this approach is their biological age. “So you’re 30 years old, but your biological age is 20—or 40,” Dr. Krivov says. “Changes in your diet, exercise or lifestyle affect biological age. You might get younger, biologically. That would be reinforcement to the patient that he or she is doing well.”

DNA moleculeSome recent uses of big data include predicting the future of metabolic syndrome, advancing neuroscience, identifying dangerous pathogens, and conducting cancer research, among many others. DNA sequencing is getting cheaper thanks to big data, and genetic sequencing with big data is becoming a key part of epidemiology, because it helps trace chains of infection. Big data is helping researchers not only to understand the different genetic mutations in cancer, but also to personalize medicine: different mutations respond differently to treatments, and getting the right treatment straight away spares patients from side effects of treatments that aren’t effective for their particular kind of cancer.

However, challenges remain for big data to reach its full potential of analyzing many kinds of information from many patients. With computers, it’s “garbage in, garbage out,” so data needs to be structured to ensure consistency. Information often isn’t shared because organizations lack procedures or systems for communication. Advances in technology are helping to overcome some of those challenges, according to “The ‘Big Data’ Revolution in Healthcare,” a study by McKinsey & Co.

Big data is still a work in progress in medicine. “If a certain number of people have a disease, the task of searching for them will take minutes instead of days,” Dr. Sejdic says. “But for other things, it will still take days because you need to develop software first for analyzing the data.”

Too much data can be a problem, too. “When you know what you want to find out, it’s a much easier problem,” he says. “But if you’re looking for new patterns, it’s more of a fishing expedition. Whenever we do clinical trials, we are flushing out the details. There’s so much information that it’s hard to track it. Until we do that, we won’t have a good understanding. The major change will occur in the next 10 to 15 years.”

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

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.



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