Perma Pure is a leading manufacturer of gas conditioning products.

HaA took on the design and development the O2asis with challenges ahead, including the testing involved with a respiratory device involving rigorous biocompatibility and safety analysis. Other factors to assess was the design and manufacture of a device with electronics, heat, oxygen and a water reservoir.

Mixing electronics, heat, pure oxygen and water together can be a recipe for disaster. That’s why when designing the O2Asis, HaA needed to be disciplined and careful, while still keeping their fresh design sensibility. One of the biggest challenges faced was the line coming from the device to the consumer. It carries humidified oxygen, and has to be heated to an ideal temperature to prevent “rain out” (condensing) of the water. Also, this is a critical area of the device, as the heat is derived electrically, and a factor of safety is required. This was accomplished by utilizing a special wire that we sourced, and low voltage electricity. Another roadblock to overcome was the heating pad for the water reservoir itself. By integrating electronics into a printed heating pad, we were able to precisely control and define the heat profile to work in synchrony with the heated line.

The O2asis Humidifier is a safe prescription device intended to add warmth and humidity to breathing gases for administration to a patient and is for use with oxygen concentrators or gas sources in homecare, hospital, extended care facilities, and hospice environments. The O2asis Humidifier is a non-sterile device intended for patients who require humidification of supplemental breathing gases between 0.5 and 6 lpm and is for single patient use, although it may be used by multiple patients. This is the case if the consumable water well cartridge is replaced prior to transfer of the device to a new patient.

This palm sized device provides comfort when used with home oxygen, while humidifying & delivering warmed air through the cannula. Users can carry the device or place it alongside them when plugged in at home or revive hours of humidification on-the-go. The O2asis provides so much more humidification than a bubbler without the associated drawbacks.

Radiadyne works closely with HaA to develop advanced medical devices, including life changing transformation in Dosimetry Monitoring. After eight years and millions of dollars invested in research and development, OARtrac is the first of its kind radiation dose monitoring platform providing gold standard accuracy without correction factors, real-time pinpoint measurement, and dedicated intracavitary delivery devices to measure where it counts.

OARtrac monitors multiple cancer treatment modalities within the same treatment center, as well as reduces overall treatment costs related to routine patient dose monitoring through a reusable dosimeter. The OARtrac system provides dose data for the radiation oncologist to decipher and use to adjust a patient’s treatment plan accordingly, therefore providing true adaptive radiotherapy for personalized cancer treatment.

Eric Hyman, HaA's VP of Engineering, was heavily involved with the overall product development, engineering and manufacturing process of the OARtrac, receiving a 2018 MedTech Engineering Award.

Insulet was about to change the industry with a revolutionary insulin management system. HaA helped that revolution become a reality.

The OmniPod is the first tubing-free insulin pumping system. It is discreet, durable, wireless, watertight and incredibly easy to use. The Pod holds and delivers insulin. The OmniPod is unique with ability to be adhered almost anywhere on your body. It is simple to use, robust and safe. The PDM (Personal Diabetes Manager) wirelessly programs, personalizes insulin delivery, calculates suggested doses, and has a convenient, built-in blood glucose meter. (To read more - www.myomnipod.com) As a company, Insulet invested substantial money defining the overall look and feel of their product. The did a great job with the UI/UX. The next step was to engineer and manufacture a cost effective high volume disposable product (the POD) and a relatively low volume electronic device using the same design/development controls. Our experience and numerous personal connections expedited this process.

Personal Diabetes Manager (PDM) As individual contributors and as a Team, we were tasked with the engineering, DFM, FMEA, Environmental Testing Specifications, Full Documentation Package (CAD drawings) and initial Manufacturing Fixturing and Manufacturing processes. We also supported the documentation for UL and CE submissions. The aggressive schedule required engineering CAD to be completed in 10 weeks and have a full function unit within 5 months. This was successfully completed! In summary, the PDM was engineered from a concept drawing to a fully functioning manufacturable design within one year. (Of course, the manufacturing line and testing/certifications took equally as long to complete)

Addition tasks and successes Introduction of the 2 shot molding process for the electrical Chassis of the OmniPod. (MGS acted as initial engineering consultants) Engineered the OmniPod outer shell taking into consideration the many internal parts, built-in insulin reservoir, angled infusion set, automated inserter, pumping mechanism and power supply etc. This also included defining how development

Work was performed by Steven Lepke while at Insulet with HaA supporting the work required to meet schedule.

Project Details

Medical
Insulet Corporation
Engineering & Manufacturing Support

The Boston Scientific eXcelon Transbronchial aspiration needle is a minimally invasive procedure used to collect tissue for the diagnosis and staging of lung cancer. It is a safe, economical device with a low incidence of complication, it lowers the need for invasive surgical procedures and also reduces healthcare costs.
As the global leader of less-invasive medical devices, Boston Scientific wanted to simplify Transbronchial Needle Aspiration (TBNA) –The original Boston Scientific needle assemblies were two-handed devices, with multiple pieces that often detached, bent or kinked. Leaks in the wire assembly would dislodge biopsy samples from the needle, necessitating a repeated procedure. In short , these needles were difficult to use, expensive to manufacture, and sometimes failed during the procedure. Our main goal was to improve the UI/UX and if possible reduce the overall manufacturing costs. The schedule was to complete a production ready version within two months.
From initial research, it was determined that the original needles were not only a two-handed operation, they were commonly a two-person operation. This required clear communication and coordination between the doctor and the scrub nurse. Time tracking helped us prioritize feature requirements.
With research phase complete, the HaA team then focused on concepts with a syringe locking feature that allowing single-handed actuation. With the understanding that a single handed actuation was necessary it became apparent that their existing assembly methods were not optimal. HaA recommended the needle actuation and syringe vacuum to be offset. This enabled us to eliminate most of the tight tolerances and drastically reduce cost. The new Swordfish form evolved quickly from there.
In summary, the freeing of the hands of the surgeon set this device apart from competitors. The new UI was intuitive and quickly learned by its users. The procedure time was reduced and the issue of dislodge biopsies was eliminated. Manufacturing costs were drastically reduced.
This award winning product has been very profitable for Boston Scientific!

Project Details

Medical
Boston Scientific
Engineering, Test Development, Manufacturing Support, Usability

Creating a pediatric solution for a revolutionary mobile scanner:

Neurologica, the maker of a revolutionary movable CT scanners faced a challenge. Having developed their scanners with the brain injuries of adults in mind, they realized that they were also ideal for pediatric care.
Neurologica faced a problem. It needed a design solution that would communicate that it’s machines were designed with pediatric care in mind. Being new to the industry Neurologica did not have a brand that was known within pediatrics. In addition, CT scanners are pieces of equipment that are needed at a time when children and their parents are stressed, afraid and unwell. Due to cost constraints the Neurologica CereTom unit was fabrication from sheet metal and did not look approachable or communicate the modern and sophisticated technology that was inside it.
The designers considered the whole experience for all the stakeholders involved. Patients that needed to be distracted, parents that needed to be calmed and caregivers that needed story lines with which to engage their parents. The design team decided to develop graphic solutions that could be applied to the outside of the CT scanners. This provided a cost-effective solution that could work for a range of children’s ages from infants to toddlers and preschoolers.
For infants a calming sea scape would reassure parents and would provide medical staff with opportunities to engage the infants through a variety of images and references.
For toddlers and preschoolers, the designs presented friendly caring cartoon animals in engaging environments that would intrigue and entertain the patients.
The new designs transformed the scanners into products that could easily be associated with the pediatric environment and showed that Neurologica was serious about addressing every aspect of the scanning experience for patients, parents and caregivers. Within weeks of the first design being completed Children’s Hospital of Boston became the first pediatric care unit to install one of Neurologica’s pediatric CT scanners.

Project Details

Medical
Neurologica
Industrial Design & Graphic Design

Back pain is a common complaint due to osteoarthritis, herniated discs and stenosis. To repair damaged discs and provide relief from pain, surgeons were manually injecting fluids into spinal discs but had no real way to gauge feedback other than patient pain. The procedure was painful, slow and inaccurate.

The HaA designed CDS System offers physicians a more reliable, consistent and accurate tool. It is lightweight, portable, and easy to use. A touch-screen panel displays patient, procedure, and physician reference data, while the system monitors all critical parameters during the procedure.

Coupled with an adjustable flow rate and pressure sensors, the system ensures reliable, accurate performance, as well as reduced patient pain, faster recovery and more successful procedures.

Project Details

Medical
Smith and Nephew
Engineering, Industrial Design, UI, UX, GUI, Introduction to Tooling Vendors,Manufacturing Support

illumia®lite is a robust, sphere based, hand-held spectral flux analyzer. The analyzer has self-absorption correction that is both reliable and affordable. The illumia lite performs equal or better than the more commonly used bench units. It is the leader of hand held analyzers.

Labsphere is an internationally recognized photonics company. They manufacture precision standard, custom radiometric and photometric products addressing specific needs of the aerospace, automotive, electronic imaging, laser diode, LED, lighting, medical imaging and optics industries. They also provide custom integrated solutions for customers who require superior optical calibration services.

Labsphere came to HaA for help in designing a low cost, human factors friendly product, that was durable, customer serviceable (light replacement) and that would meet their strict performance requirements. The difficulty in this type of product was that the unit needed to be completely light tight. If the unit wasn’t reliability sealed during manufacturing, the readings from the unit would be inaccurate. The combination of needing to be light tight and the customer bulb replacement, required the HaA design and engineering teams to work closely to be innovative with how the system as a whole would function and be manufactured.

The output was a device that met Labsphere’s specifications and met all of HaA’s UI/UX standardized requirements. Customers liked the look of the integrated unit and stand, the compact size, balanced feel and its overall UI. They felt the product is very intuitive to use.

Project Details

Medical
Labsphere
Industrial Design, Engineering, Cost Reduction and Manufacturing Support, UI / UX Overview