PROJECTS
Ear-Worn (Hearables)
Hearables are medical devices (hearing aids) or consumer devices (audio playback) worn in or around the ear. Some devices have been associated with skin irritation (rash, discharge, pain). BOHLD consulting has fielded skin related questions for in-ear, around-the-ear and over-the-ear type devices. We examine individual case reports and generate diagnostic summaries detailing the likely diagnoses. Our current breadth of experience includes fifteen different hearable devices designs produce by various companies. Our work has changed manufacturing practices to eliminate possible allergens, re-design devices to enhance comfort and wearability and revised protocols for device care and use to minimize skin irritation risks.
Wrist-Worn
Wrist worn devices include consumer products such as smart watches, fitness trackers and medical devices. BOHLD has consulted on over twelve different wrist-worn sensor platforms and many different wrist strap materials from multiple companies. We examine individual case reports and generate diagnostic summaries detailing the likely diagnoses with particular focus on irritant contact dermatitis, allergic contact dermatitis and thermal injuries. BOHLD has participated in prototype design regarding how to redesign watch bands to minimize skin irritation. BOHLD has partnered with a leading academic institution to help identify common triggers of skin irritation between the device and skin. To aid these evaluations, novel material testing of watch band materials has been completed to identify ideal breathability for watch band materials. BOHLD has also helped develop consumer tools to clarify optimal tightness with which device should be worn to reduce skin irritation risks.
Medical Devices
Medical devices that are worn or adhere to the skin have been associated with skin irritation. BOHLD consulting is assisting medical device companies to help identify possible triggers for skin irritation associated with their skin worn sensing devices. BOHLD is also helping to develop wear protocols for their devices to ensure patient comfort while achieving optimal signal to noise ratios for the device sensors.
Microneedle Arrays
Microneedle Arrays are at the cutting edge for diagnostic testing and drug delivery. These involve arrays of microscopic needles that pierce the top layers of skin in order to sample the interstitial fluid or deliver medications. BOHLD is assisting a medical device company developing a microneedle array patch.
Patch Testing Protocols
Patch testing is a skin test which assesses the sensitivity of individuals to particular allergens or materials. When a device causes skin irritation concerning for allergic contact dermatitis (ACD) potential allergens are often identified by extractable and leachable chemical analysis. Patch testing with purified, validated allergens can verify if the identified allergens cause skin rashes in the sensitize users.
An alternative test to assess whether users are sensitized to a particular material or device component is called use-testing. In use-testing, materials from the device that has triggered the skin irritation are placed directly on the skin of the sensitized user. Skin reaction to particular device materials or component can confirm the presence of an allergen and permit a focused analysis to more rapidly identify the culprit allergen.
BOHLD has worked with multiple companies to generate patch testing or use-testing protocols and can partner with credentialled medical providers to assist in performing these tests.
Threshold and Predictive Diagnostic Tools
The questionnaires designed by BOHLD are used by our consultants to generate accurate medical assessments of underlying causes for skin irritation. They are also design to be quantifiable so that skin irritation cases can be assigned a unique score which corresponds to a clients particular threshold for concern. The threshold can be based upon different clinical criteria which are selected by the client and based upon data analysis of a representative cohort of completed questionnaires. This can reduce the number of skin irritation cases that undergo high level review, leading to significant savings in manpower and resources. The scoring can be automated to generate instantaneous, first pass analysis.
For some clients, BOHLD has developed predictive diagnostic tools (PDT) that allow automated, instantaneous analysis as questionnaires are completed. The PDT assigns specific diagnoses based upon the profile of questionnaire answers allowing a greater level of first pass analysis specificity compared to threshold analysis. This can further reduce the number of cases that require high level medical review or destructive failure analysis, likewise generating cost and manpower savings.
These types of analysis tools are particularly beneficial for companies that experience large volumes of skin irritation reports, companies with small customer experience staffs or companies that only have non-clinical support staff.
Medical Risks of Chemically Strengthened Glass
The screens of smartphones, smartwatches and tablets are made of chemically strengthened glass with a special conductive chemical coating (aka smart glass). BOHLD has assisted in assessing the fracture pattern of smart glass that occurs when dropped, predicted the types of injuries that might occurs with shards of smart glass, determined how detectable smart glass shards might be if imaging studies are necessary to located embedded glass fragments and reviewed the medical literature to predict its immunogenicity.
AR/VR Skin Irritation Survey
AR/VR next-generation devices are close to release. BOHLD has developed a skin safety survey to best capture information about skin irritation with users of these devices should it occur.