The Living Heart Project: Remarkable Progress Achieved Through a Common Goal to Improve Cardiovascular Disease Outcomes

By Helene

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Steve Levine, Chief Strategy Officer for SIMULIA Dassault Systèmes, is passionate about bringing cutting edge technologies from different disciplines to doctors and the patients they treat. In a recent recorded presentation at the 3DEXPERIENCE Forum in November 2014, Levine outlined the need for utilizing these technologies to build better human anatomical models, stating that 95% of all medical devices released to the public have never been tested on the human body.

The Living Heart Project was launched publicly in May 2014 to develop the world’s first realistically functioning computer model of the human heart. This project has made tremendous progress, and the video referenced above includes Levine and Dassault Systèmes President and CEO Bernard Charlès announcing a 5 year collaboration with the Food and Drug Association to develop cardiovascular testing paradigms.

The Living Heart Project relied on Dassault Systemes 3DEXPERIENCE platform to bring together more than 100 cardiovascular specialists from 30 organizations to develop and test the model. In the video, Levine commented that at the outset, bringing together researchers, doctors, medical device companies, and regulatory agencies was a challenging task as information is siloed. The 3DEXPERIENCE platform allowed the specialists to crowdsource the heart model, with each bringing their expertise without sacrificing intellectual property.

The video shows impressive visualizations of The Living Heart model that are, pardon the pun, heart stopping. Levine points out in his presentation that it is the first four chambered 3D heart model that is based on commercially available, validated technology. He also showed that the model can be viewed in different ways, highlighting mechanical stresses important for indications such as heart failure as well as visualizing electrical conductivity which is important for studying heart arrhythmia. Levine also showed how collaborations within Dassault Systèmes were instrumental to visualize The Living Heart in 3D, as a “walk in” model. Additionally, 3DEXCITE provided true to life coloring and features to aid medical students and surgeons.

Levine went on to tell the story of Emily, a girl born with a heart that is literally “backwards,” with right and left ventricles transposed. As the earlier 3D models Levine showed in the presentation illustrated, the heart is not symmetrical, so this defect has caused Emily to have 4 pacemakers by the age of 20. In May 2014 an animated video showed Emily’s story and how the The Living Heart would help diagnose and treat her. Emily’s story is particularly touching for Levine to relay, and the reasons are best explained by him, so we encourage you to watch the entire video of his talk to learn why.

Levine talked about the collection of resources available at 3ds.com/heart which helped to describe the vision of the Living Heart Project to collaborators and to illustrate their progress.  He sees the project as a model to unite other healthcare specialists, medical device companies and regulatory bodies to collaborate around aspects of human anatomy or disease models. The 5 year collaboration with the FDA will increase the number of participating organizations from 30 to 100 and will continue to involve the Medical Device Innovation Consortium of which Dassault Systèmes is a key sponsor.

Making Global Medical Device Product Innovation A Reality – Watch the Webinar Replay

By Helene

Technically and geographically diverse product development teams must work together more closely than ever to develop medical devices which will focus on the needs of patients and doctors globally. In order for medical device companies to compete, traditional voice of customer (VOC) approaches need to keep pace with healthcare consumers increasingly sophisticated product needs. Medical device product innovation can result from improved ideation which facilitates collaboration between all global stakeholders.

Medical device product development is a complex process involving research and development teams, designers, and the marketing and regulatory teams that gather requirements from customers and governing agencies. A 2012 report from Axendia titled “Walking the Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization” highlights the opportunities and challenges posed by increasing globalization. Medical device product opportunities lie in growing global patient markets and working with outsourced partners in a more collaborative role. Challenges include increasing data visibility and analysis as well as keeping track of regulations for each region.

Smart Watch Design for the Life Sciences Industry

Smart Watch Design for the Life Sciences Industry

Dan Matlis, president of Axendia, was one of three speakers at Dassault Systèmes (3DS) sponsored webinar during the December 3rd (now available on replay) discussing results from this report as well as ways medical device companies can address them. The webinar titled “Learn How Leading Medical Device Organizations are Driving Innovation in a Global Marketplace”  also included Cathi Crist, Partner and leader of the Life Sciences practice at Kalypso where she educated viewers on how product lifecycle management (PLM) facilitates innovation. Rounding out the webinar was Stuart Karten of Karten Design, where he shared his firsthand insights on how leading medical device organizations are leveraging design and innovation to improve and create new products. Click here to watch the webinar replay.

Today’s global consumers develop strong and sometimes very personal reactions about the healthcare products they experience, and are quick to discuss their likes and dislikes via social media. These tweets, Facebook updates, and Instagram posts in turn create more discussion and opinions among their network and beyond. These data create a rich product development resource for medical device companies. Focus groups and surveys have always been used by companies to gauge needs of their customers, but they can be time intensive and expensive. Innovative medical device companies realize that listening to customers first, in real time, rather than being reactionary when complaints arise, will be the winning strategy. Indeed, putting patients and doctors first, and even involving them in the product development process, will result in more customer satisfaction and sales.

The Dassault Systèmes Ideation and Concept Design for Medical Device Industry Solution Experience redefines medical technology workflow via social collaboration. Powered by the 3DEXPERIENCE platform, it is the first cloud-based, all in one innovation management system. This solution was highlighted during the webinar, and in keeping with social collaboration, we hope you can join the discussion, and leave any comments or questions below.

Medical engineering’s future frontiers

By Catherine

By Catherine Bolgar*

Future technology to detect and treat diseases is coming from some surprising sources. We talk about “fighting diseases” or “fighting cancer,” for example. Well, how about using military technology for medical devices?

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MelaFind, which is already on the market, uses innovative spectral imaging and software-driven technology born from missile-navigation systems to help dermatologists detect melanoma at its most treatable stage.

Melanoma accounts for only 5% of all skin cancers but is responsible for 75% of deaths. Caught early it’s almost 100% curable; however, by the time melanoma goes more than 1mm below the skin, patients have a 50% chance of dying, usually within a year.

“Dermatologists are probably the last group of physicians who don’t use imaging as a standard,” says Rose Crane, chief executive and president of MELA Sciences, the Irvington, New York, company that makes MelaFind. While dermatologists are very good at spotting melanoma vs. benign moles, many cases are difficult and ambiguous for them, she says.

MelaFind uses spectral light to illuminate the skin, and then provides the doctor with 3D images, as with magnetic resonance imaging. Then, the images are analyzed with proprietary algorithms that provide the doctor with data on the probability of the lesion being a melanoma based on the largest positive, prospective study ever conducted on the disease.

It’s able to non-invasively image and analyze irregular moles 2.5mm below the skin surface where a doctor can’t see unless he/she cuts,” she says.

Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) is another device that uses military technology for medical imaging. NIRF-LI stands for “near-infrared fluorescence lymphatic imaging,” and uses infrared military-grade night-vision technology to see the body’s lymphatic structures and flow for the first time.

Watching television coverage of nighttime operations during the first Gulf War, Eva Sevick-Muraca, now professor of molecular medicine at the University of Texas Health Science Center at Houston, or UTHealth, recalls that she “had the crazy idea that we could use near-infrared fluorescence for medical imaging. We don’t have any natural molecules in the body that fluoresce at these wavelengths, but if we could find a molecule that does and use it as a contrast agent, we could use harmless light for medical imaging.”

Indocyanine green, or ICG, fluoresces when illuminated with near-infrared light. Once a tiny amount of ICG is injected into the skin, the lymphatics draw the dye into the lymphatic vessels, through regional lymph nodes and beyond. When dim laser light illuminates tissue surfaces, the dye “lights” up, and NIRF-LI enables visualization of the ICG moving through the lymphatics, explains John Rasmussen, assistant professor at UTHealth. NIRF-LI can take pictures of this so quickly that it can image actual lymphatic flow.

The device is important because the lymphatics play a role in many diseases and conditions that are becoming more prevalent, including cancer, lymphedema, autoimmune diseases, asthma, chronic wounds, vascular disease and others.

Doctors typically check lymph nodes for cancer when removing tumors, but lymph nodes aren’t in exactly the same places in each person, so surgeons have to hunt for them. Once found, the lymph nodes are removed for biopsy to see whether they are cancerous. Eventually, using cancer-targeted imaging agents, NIRF-LI could be used for “image-guided lymph node dissection,” says Dr. Sevick, to determine whether they are cancerous before removing them.

Drs. Sevick and Rasmussen hope that they and their industrial partners, NIRF Imaging Inc., based in Montgomery, Texas, and Exelis Inc. of McLean, Virginia—the leading supplier of military night-vision goggles—will have NIRF-LI on the market as soon as next year.

Other futuristic devices aren’t linked to military technology. The MINIR robot, being developed by Jaydev P. Desai, professor of mechanical engineering and specializing in robotics at the University of Maryland, can remove brain tumors while causing minimal damage to healthy tissue. The robot is made of plastic so that it can be deployed in the brain while the patient is in a working MRI machine. A physician would view the brain and the robot on the MRI interface, and remotely control the robot toward the tumor. The robot would then electrocauterize the tumor and be guided back out.

The robot, whose prototype resembles a small finger, is called MINIR for “Minimally Invasive Neurosurgical Intracranial Robot.” Some tumors can’t be reached by common surgical approaches. “When surgeons try to get to a tumor, in the process you may cause trauma to normal brain tissue,” Dr. Desai says. “Our challenge is can we get to that location while minimizing the trauma and then can we get the tumor out.”

Another device Dr. Desai is working on is a special catheter. Physicians now use a catheter, which is thin and flexible, to get into the body, for example, into a vein.

What if you had the ability to control how to bend a thin robotic catheter with an integrated diagnostic or therapeutic device or both,” he says.

This steerable, robotic catheter could send in an optical coherence tomography probe for diagnostic imaging. That would let a surgeon better see what is happening inside the body. A catheter that can bend at a surgeon’s will “can get around structures in the body that you want to avoid,” Dr. Desai explains.

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



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