Grand Prize Winner

ChemoPatch

Alydaar Rangwala, Nikhil Mehandru,
Aaron Perez, and Brandon Sim
Theratech, Loudonville, NY

Existing methods for administering chemotherapy drugs have been primarily through intravenous delivery via a complex and costly pole-based infusion pump setup. These setups are needed to administer complex drug schedules, and, as a result, infusion pumps have prevented treatment for early-stage cancers from becoming widely accessible.

To find a better solution, four Harvard University students from several disciplines have founded Theratech, and introduced the ChemoPatch™, a low-cost, disposable, and electronic patch-base cancer chemotherapy device designed to be simple, automated, and easy-to-use by cancer patients outside of the hospital, yet cutting-edge in its ability to deliver early-stage chemotherapy.

Iontophoretic electronic technology was first introduced to the market in the 2000s as an alternative to infusion-based set-ups, but was never proven to adequate for two main reasons: it requires chemotherapy infusion drugs to be reformulated for storage in the iontophoretic patch reservoir, and it only allows for one drug at a time.

The ChemoPatch fills both of these technology gaps at a much lower price. Chemotherapy drugs can be loaded as they currently exist and the ChemoPatch is able to administer up to three different chemotherapy drugs in select doses and at specific time intervals. Additionally, drug delivery is automated, allowing patients to reduce the frequency of hospital visits.

This innovative technology is the result of employing cutting-edge microfabrication resources at the Harvard School of Engineering and Applied Sciences. Specifically, the ChemoPatch costs of four components:

  • a novel, patent-pending micropump for drug delivery,
  • a drug reservoir that contains up to three separate chemotherapy drugs,
  • a microneedle array for painless administration of drugs, and
  • a simple microcontroller-based electronic circuit for complex programmable delivery scheduling.

At the heart of the ChemoPatch is the patent-pending plastic-based and low cost micropump technology. Theratech has developed the first highly accurate micropump that is completely plastic-based, allowing for the first truly disposable micropump- based patch technology for drug delivery.

In order to demonstrate the viability of the ChemoPatch, Theratech is conducting a pilot study of early-stage breast cancer in India within the next 12 months. With more than 115,000 new diagnoses in India each year, there is a sizeable need for better treatment. The company plans to introduce the ChemoPatch in the US pending regulatory approval. The end goal is to bridge the gap between technology and costeffectiveness in high-quality first-line cancer care, making it accessible for all.

For more information, visit: http://contest.techbriefs.com/grand-prize .


Medical Category Winner

Vitalflo

James Dieffenderfer, Mike Brown,
and Leigh Johnson,
North Carolina State University,
Raleigh, NC

More than 25 million Americans have been diagnosed with asthma, and it ranks as one of the top five most expensive diseases, costing the US more than $63 billion annually. While more than 60% of asthmatics own a peak flow meter (PFM); only about 35% actually it. Regular use of a reliable PFM and monitoring of one’s respiratory vitals would create a better asthma management plan, and in turn, reduce the effects and severity of their asthma.

The Vitalflo device offers a reliable monitoring solution to help consumers monitor their breathing, while delivering an education solution showing the best ways to manage and treat changes in their breathing through integration with their smartphone. It fills current unmet needs by utilizing the most accurate lung capacity measurements, reducing overall device size for ease of transport and storage, integrating wireless technology to seamlessly transmit data to any smart phone or PC, functioning fully as a standalone device, and offering a dashboard of additional features and benefits.

James Dieffenderfer, team leader, said: “The problem of asthma treatment and prevention stood out to us because of the vast amount of people that are affected by this disease. We wanted to somehow bridge the apparent gap that exists between patient and physician to increase the efficacy of treatment. After a series of interviews, we narrowed our focus to creating an improved peak flow meter, one that meshed well with current technology. It wasn’t until halfway through the design process that we discovered that Vitalflo could also be used as a spirometer. This enables us to help an even larger amount of people, including those suffering from COPD. We started on this project with the belief that we could improve the lives of millions of people and it remains our motivation to this day.”

This project was backed by the Nanosystems Engineering Research Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) at North Carolina State University (http://assist.ncsu.edu ). Dieffenderfer explained that the entire Vitalflo project actually started from the Product Innovation Course, which allowed the research team to be mentored by faculty at the ASSIST Center. The device was conceived using situational analysis tools, moved to product development, then engineering through technical advancements.

For more information, visit http://contest.techbriefs.com/medical-winner . To see a video of this technology, visit www.techbriefs.com/tv/vitalflo.

Honorable Mentions

OrthoSensor™ VERASENSE™ Knee System

Carlos Gil
OrthoSensor, Inc., Sunrise, FL

The VERASENSE is an intelligent single-use surgical device used during total knee arthoplastic (TKA) surgery to help the surgeon balance and align the knee. The device uses a sensor to give the surgeon feedback on load on the knee as well as mechanical alignment of the patient’s leg.

The device uses RFI to communicate to the non-sterile field where a graphic user interface provides the surgeon with real-time quantitative data to enable evidencebased decisions regarding component position, limb alignment, and soft tissue releases to achieve balance and stability through a full range of motion.

VERASENSE is compatible for use with multiple knee implant systems and utilizes proprietary sensor and accelerometer technologies to sense dynamic loads and femoral contact point in the medial and lateral compartments of the operative knee through a full range of motion, and to verify limb alignment.

The device is intended to address the leading causes of early implant failure in TKA: instability, malrotation, and malalignment. Research published in the HSS Journal, the musculoskeletal journal of the Hospital for Special Surgery, has shown that instability and misalignment cause approximately 36 percent of all orthopedic implant failures.

For more information, visit http://contest.techbriefs.com/verasense . To see a video of this technology, visit http://www.techbriefs.com/tv/orthosensor.


Exo Dynamics LLC – ExMS

Jorge Sanz-Guerrero, Dan Johnson, Sam Beckett,
Alejandro Catalan, and James Buquet
Exo Dynamics LLC, Ann Arbor, MI

Exo Dynamics is a medical device startup dedicated to creating the next generation of innovative spinal orthoses, devices meant to provide support and mobility. Its first product is based on PhD work conducted by its Chief Technology Officer Daniel Johnson. Exo Dynamics currently has an option agreement with the University of Michigan to use the IP for further business development.

Its first product is the ExMS-1, an “electromechanically activated” back brace. Unlike current braces, our device focuses not on increasing abdominal pressure, but on transferring the weight of the torso to the hip. This gives support to the back muscles, thus reducing their effort. By changing its shape as the user moves, it allows for free motion of the user, maintaining support through a wide variety of postures, thus substantially reducing the strain on the lower back muscles and spine.

The ExMS-1 is able to provide these features due to active mechatronic technology, which incorporates an electronic control system that takes input from a network of sensor elements around the back brace and then adapts the controls and actuators in real-time to maintain a pre-programmed level of support for its user. As the user moves, the orthosis tracks this motion, calculates the new parameters needed for the desired pre-programmed back support, and adapts the device accordingly.

As the patient recovers, a clinician could remotely adapt the orthosis mechanical response (range of motion, mechanical stiffness/damping) that gradually reintroduces motion while lowering support, thus leaving the patient with a more normal level of spinal mobility and reduced need for further physical therapy. Additionally the device could also be programmed with prescribed exercise routines, helping with the compliance of a patient’s treatment.

For more information, visit http://contest.techbriefs.com/exms . To see a video of this technology, visit http://www.techbriefs.com/tv/exms-1.


Medical Design Briefs Magazine

This article first appeared in the November, 2013 issue of Medical Design Briefs Magazine.

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