Biodesign

From Ideation to Prototyping to Clinical Evaluation 

We provide our students the hands-on experience of conceptualizing, designing, building, and clinically evaluating a working prototype of a medical technology that addresses an unmet clinical need.

Biodesign projects span the entire length of the one-year program and are the cornerstone of the MTM program. Alongside industry and/or clinical sponsors, our students work in multi-disciplinary teams to utilize the technical, business, clinical, and regulatory principals they learn in the core MTM curriculum.

Teams are purposefully comprised of students from a variety of STEM academic backgrounds such that everyone has the chance to learn from each other’s expertise and is surrounded by a diverse group of thought and ideas.

Fall

Teams identify an unmet clinical need, develop multiple design concepts and work with faculty and sponsors to select the concept that best addresses the need.

Spring

Teams build a working prototype of their technology and explore initial market response and customer discovery.

Summer

Teams collect initial data and user feedback to guide refinement of their design.

In their final semester, teams enter the clinical setting to collect initial data and user feedback to guide refinement of their design. At the conclusion of the program, teams may explore opportunities to pursue further development of their prototype. In addition, each team evaluates the opportunity to file intellectual property surrounding their technology.

At the conclusion of each semester, teams take part in a comprehensive project review that is modeled after the Stage Gate process commonly used in the medical technology industry. During these reviews, senior faculty and administrators join industry and/or clinical sponsors to provide feedback to the teams and ensure that they remain on track to successfully complete their project. As part of the final grade, each team is required to file a comprehensive report at the conclusion of the program to document the details of their project.

Dermi

Dermi:Avi S. Albeg, Brandon May, La Shawn Pearce, Priotush Talukder, Shane Mayack
Project Sponsor: Galderma

Blood and needle intolerance affects upwards of 15 million adults and 5 million children in the US. The quality of care of patients with blood and needle intolerance decreases due to an increase in procedure time, as well as some patients avoiding blood draws and doctor visits altogether. Current available solutions are insufficient to provide the care these patients need. The use of interstitial fluid as a reservoir of physiological data allows for a shift away from a traditional blood draw. Dermi is developing a less invasive device-based collection method for dermal interstitial fluid, with on board biomarker detection and analysis.

.

EntreDerm

EntreDerm: Lesly Polanco P, Zachary Werner, Victor Adedara, Lourdes Endara
Project Sponsor: Galderma

Pressure ulcers form as a result of soft tissue compressing between a bony prominence and an external surface, causing necrosis and ulceration to the area. They affect 2.5 million people and cost $9 to $11 billion to the healthcare system annually. The current standard of care involves visual inspection and repositioning the patient every two hours. EntreDerm’s goal is to develop a device-based solution to predict the progression of pressure ulcers before Stage 1 in patients who are unable to independently mobilize. This remote monitoring tool will notify nursing staff before the development of Stage 1 pressure ulcers to help reduce their incidence rate.

Excelsior

Excelsior:Michael Balangue, Leonard Chavannes, Philip Coatl, Tawai Gbollie, & Chaya Sussman
Project Sponsor: Galderma

Approximately 76% of patients with atopic dermatitis experience sleep disturbances due to nocturnal pruritus. These sleep disturbances have a negative impact on the general quality of life with poor outcomes such as daytime fatigue, poor overall health perception, mood disturbance, increased levels of stress and depression, and impaired neurocognitive functioning. HYPNOS is a wearable device used to reduce the occurrence of sleep arousal caused by nocturnal pruritus of patients affected by atopic dermatitis. Excelsior’s solution will provide automated treatment via TENS technology to add an additional sleep cycle that would amount to up to 90 minutes of sleep.

Occam Medtek

Occam Medtek: Abdul R Abdulai, Danna Cruz, Oliver Brannigan, Wasem Khalid
Project Sponsor: Galderma

Atopic Dermatitis (AD) affects 9.6 million people in the US, with itching percisisting for >12 hours a day for patients with mild to moderate AD. Occam Medtek is developing a device-based intervention to help adult AD patients manage their chronic itch symptoms by limiting the amount of time spent scratching using thermoelectric cooling technology. Current treatments are limited in frequency of use such as topical steroids and UV therapy. DermaFrost is a lightweight, portable, ergonomically designed thermoelectric cooling device that will be used as an adjunctive to common AD therapies.

Skin & Bone

Skin & Bone: Airagha J Aldefri, Daniel Villarroel, Marin Sabu, Cory Crew, Ahmed Ramadan
Project Sponsor: Memorial Sloan Kettering Cancer Center

Blood cancer patients are often put through a trial-and-error treatment approach. Skin & Bone worked to develop a device to facilitate the shift towards a more personalized treatment plan.The team designed a multiple tissue biopsy collection tool to be used by clinical oncologists. By collecting a diseased bone marrow sample and a healthy skin sample, clinicians could compare the genetic data to determine a more effective treatment course, aiming to reduce the incidence of relapsed patients.

Shikatech

Shikatech: Anuoluwapo Bolarinwa, Alex Chalco, Luis Marin-Gomez, Tasnim Islam
Project Sponsor: Memorial Sloan Kettering Cancer Center

Patients who undergo radiotherapy to treat head and neck cancers often develop trismus as a side-effect. Trismus affects a patient’s ability to open their mouths beyond a few millimeters, making it hard to maintain good oral hygiene. Dentists are unable to treat complications as they arise, since they aren’t able to access the mouth. Shikatech developed a specialized toothbrush, designed for even the most extreme trismus cases. They focused on prevention; establishing a strong oral hygiene routine for the patient would lead to fewer downstream complications, and therefore a better quality of life.

DermaSee

DermaSee: Cira Cardaci, Chaya Edelman, Bo Guan, & Mican Meneses
Project Sponsor: Galderma

Menopausal women often experience symptoms such as hot flashes and dry or itchy skin. With the goal of improving the quality of life and health literacy of menopausal women, DermaSee is developing a pendant that contains temperature and moisture sensors that will detect and track hot flashes and changes in skin moisture. The user can access their measurement data, educational information, a symptom diary, and a support group via an iOS app.

SkInsight Health

SkInsight Health: Ashley Abid, Jeremy Kaplitt, Mohammed Rumon, & Thandiwe-Kesi Robins
Project Sponsor: Galderma

The pediatric atopic dermatitis patient population is known to not adhere to their treatment, which is crucial for symptom management and reduction of the severity of the condition.  SkInsight Health aims to help this population with their atopic dermatitis care and management by increasing treatment adherence through a personalized and holistic approach along with therapeutic education. The team will achieve this goal by integrating the quantitative measurements of skin hydration and ambient humidity/temperature with a personalized gaming app.

Motion2Movement

Motion 2 Movement: Zena Ahmed, Ralph Hertz, Janine Medina, & Ankush Thakur

Project Sponsor: Motion2Movement

Knee osteoarthritis (KOA) is a chronic knee joint disease that affects approximately 20 million Americans and often leads to pain, swelling, and joint stiffness that eventually necessitate a total knee replacement. Excessive joint forces are a common problem among KOA individuals. Motion2Movement is developing a device that is worn above and below the knee to monitor how KOA patients walk and help them prevent excessive forces on the knee joint to reduce their pain and symptoms.

PapeRid

PapeRid: Neela Qadir and Wahaj Patel
Project Sponsor: Burke Rehabilitation Hospital

When a clinical study is being designed, one of the steps involved is planning how data will be handled and collected.  Electronic Data Capture (EDC) systems allow for the acquisition, storage and analysis of clinical data in electronic forms as opposed to paper. Compared to paper forms, EDC systems improve data integrity, increase cost-savings and lead to faster study closures. The use of EDC systems in clinical settings has increased since the 1990s, however there is continued use of the traditional method, paper forms, to collect data.

There was a need at Burke Rehabilitation Center to increase the use of electronic data capture systems and enable the clinicians/researchers to transition from paper to electronic forms. The project focused on improving an Android tablet application that interfaces with REDCap. Improvements include adding a login screen, saving protected health information (PHI) to an encrypted SD card and facilitating addition of new evaluations onto REDCap through a data dictionary feature.

SenseAbility

SenseAbility: Marwah Jihad and Sadiq Rahman
Project Sponsor: Burke Rehabilitation Hospital

According to the Centers for Disease Control and Prevention, approximately 800,000 Americans suffer a stroke annually.  Approximately 88% of stroke survivors suffer from a chronic condition in which half of the body is weakened with partial loss of movement, known as hemiparesis. In addition to this physical disability, stroke survivors experience neurological deficits leading to loss in motor cognition and function. Proprioception, often defined as the body’s “sixth sense”, allows an individual to sense the relative position of their extremities in space and is vital for everyday movement.

None of the standardized assessments to evaluate proprioception have been integrated into devices to eliminate subjective and reliability issues. After analyzing various problems underlying the current methods used for proprioception assessment, there is a need to develop a more accurate/reliable method to measure sensorimotor function. This project aims to develop a system that focuses on the quantification of assessing and training the proprioceptive ability of the hand, as it is the one of the most heavily involved extremities used in daily living.

Elbonix

Elbonix: Evan Azoulay, Israel Nemet, Mehnaz Shaid and Sana Tahir
Project Sponsor: Hospital for Special Surgery

Elbow stiffness is assessed subjectively by clinicians (in conjunction with a Range of Motion measurement), and very few new technologies have emerged in the field. Elbonix sought to remove the guesswork from the equation by developing an instrumented elbow stiffness diagnostic tool. The team developed a quantitative metric of joint stiffness, allowing clinicians to accurately track pre and post-surgical recovery, as well as the effects of physical therapy or any other intervention.