Case Studies

We're improving the quality of life for the 5.3 million Americans who suffer from an ABI with our innovative biofeedback device.

A medical device manufacturer released a medical instrument that combined glass and plastic components. The plastic component was made of polyether ether ketone (PEEK), which was joined to the glass component using a cured epoxy. Through Battelle’s Surface Science program we identified an atmospheric plasma treatment as an approach to solve the adhesion problem and avoid changes to the product design or manufacturing process

A pharmaceutical company was evaluating potential options for a combination drug and injection device for a highly viscous drug. The viscosity of the drug made it difficult to inject by hand. To improve safety and reduce hand fatigue, they needed to modify the flanges or thumb pad on the syringe. There were custom-made and commercial-off-the-shelf (COTS) options available. Our client came to Battelle for help in deciding which one modification option would be most likely to be accepted by their end users.

A sponsor organization developed a novel oncolytic viral therapeutic of genetically engineered herpes simplex virus type 1 (HSV-1) targeted to treat glioblastoma. Battelle was contracted to complete a GLP, IND-enabling study, evaluating the toxicity, biodistribution and efficacy of the therapeutic in a human orthotopic xenograft model.

A medical device manufacturer was experiencing an intermittent problem with an injection-molded plastic component. During startup, parts would come off the line with a small blister in the plastic. They came to Battelle for help in solving the mystery.

Environmental chemicals that may disrupt the hormonal or endocrine systems of humans as well as wildlife and other animals have been a concern since at least the 1960s. Many of the endocrine screening assays and other tests in use today are based on or supported by research that was led by Battelle.

Prestige Brands, the parent company behind the Efferdent™ brand of dental appliance cleaners, wanted to extend their market opportunities by offering consumers a new on-the-go option for cleaning dentures, retainers, clear braces, and mouth guards. Prestige Brands asked Battelle to develop and test a cleaning formulation that could be impregnated into a disposable, textured wipe.

Although lead exposure among U.S. children is declining, significant exposure and subsequent effects remain and harm children disproportionately in certain communities. To address this challenge, Battelle developed a blood-lead prediction model that is applicable at the census tract level across the U.S. The model relies upon predictors available nationwide and can be applied to provide useful, population-level estimates of BLL in areas without available surveillance data.

The Centers for Disease Control and Prevention’s (CDC’s) has contracted with Battelle to perform formative research for this next iteration of Tips from Former Smokers anti-smoking campaign. Battelle researchers are conducting a literature review and environmental scan to evaluate emerging issues in tobacco user behavior (e.g. e-cigarette use, other alternative delivery mechanisms, and changing consumer attitudes and behaviors).

Each year, MD+DI invites innovators, entrepreneurs, students and the broader healthcare community to submit ideas for the medical device of their dreams. The “Dare to Dream” contest asks entrants to envision a new medical device uninhibited by financial or regulatory concerns. The goal is to spur bold, innovative ideas that will push the industry to rethink what is possible in the medical device realm. Entries are judged on creativity and design, market viability and their potential impact on healthcare.

Changes in electric potential and impedance of human skin can cause significant errors in biopotential measurements such as electrocardiograms (EKGs) and electroencephalograms (EEGs). Battelle researchers started with a literature review in order to find the latest research on how the structure and chemical makeup of materials impact ionic transport.

Open burning is often used in combat zones to quickly discard of waste produced during military operations. Battelle supported toxicology studies for the Naval Medical Research Unit–Dayton to better understand the health effects associated with the inhalation exposure to these emissions.

The U.S. Army Public Health Center (APHC) is responsible for informing decision making for 50+ programs that are implemented in the PHC wellness centers. Battelle provided technical assistance, training, program and policy evaluation expertise to help APHC evaluate and improve their readiness programs related to behavioral health outcomes resulting from CBRN and hazardous material exposure.

Gynecological cancers—including cervical, ovarian, uterine, vaginal and vulvar cancers—are responsible for nearly 100,000 new diagnoses and more than 30,000 deaths in the United States annually. Battelle researchers designed and executed the study to evaluate the process, reach and ultimate outcomes of the CDC campaign.

Semivolatile organic compounds (SVOCs) encompass a broad group of chemicals including flame retardants, plasticizers and stain-resistant fabric treatments, which are added to various consumer products. The Environmental Protection Agency (EPA) is seeking to better understand whether exposure to SVOCs from fabrics and other articles of commerce could impact human health.

CMS needs quality measures that can be used to determine the value of a treatment or service. These quality measures define the patient population and characteristics, the treatment or service provided and the expected outcomes for the treatment or service. With hundreds of measures in need of development, CMS came to Battelle to find a better way.

The high-profile Zika virus outbreak in 2016 proved that the disease causes serious birth defects in humans and highlighted an immediate need for an approved vaccine. Based on our successful track record in vaccine testing, Battelle was chosen to evaluate the systemic toxicity, local tolerability and immunogenicity of a Biopharma company’s purified recombinant protein vaccine candidate. The vaccine was under a clinical hold order from the FDA, which prevented it from going to clinical study in humans.

Read on how Battelle was tasked with performing preclinical safety studies to determine cause of toxicity in preclinical models of a nerve agent antidote for the DOD.

Medical equipment maker Stereotaxis collaborated with a team of Battelle medical device designers and engineers to analyze and improve how surgeons interact with heart catheters and related therapies. Battelle developed the Stereotaxis Vdrive, a technology that allows the complete heart catheterization process to be conducted remotely with a joystick control.

Our client needed a comparative formative study of two different devices for administration of glucagon in rescue situations (i.e., diabetic severely hypoglycemic and going into shock). It was critical to determine how well users were able to use the devices when under extreme stress and develop risk/safety profiles for each device.