How a Cutting-Edge Wound Therapy Device Was Developed

A wound care company enlisted the help of Logic PD design and manufacture their next generation ultrasound treatment device. The two companies worked together to create the UltraMIST therapy platform, which is designed to be easier to use than older technologies, while also being more effective at treating chronic wounds.

Logic PD

Logic PD recently helped Celleration Inc. (Eden Prairie, MN) create a smaller and more user friendly version of its MIST Therapy painless ultrasound treatment.

The technology delivers low-frequency ultrasound through a saline mist to speed up the wound healing process by simultaneously reducing inflammation and bacterial counts on the skin surface while stimulating cells within the wound. The low-frequency ultrasound of MIST Therapy has been clinically proven to stimulate cells within the wound to promote pain-free healing--something of value in the increasingly cost conscious U.S. health market, where $25 billion is spent annually treating chronic wounds, which affect upwards of 6.5 million patients each year.

Alliqua BioMedical (Langhorne, PA) acquired the MIST Therapy technology via its $30.4 million acquisition of Celleration Inc. and its UltraMIST and MIST Therapy systems just this month.

Before that milestone, Celleration officials planned on driving the growth of their business by developing a product that could help them expand into new markets. Making their next-generation technology more ergonomic and simpler to use could help expand the user base of the technology.

To accomplish this, they required a well-integrated design, engineering, and manufacturing team to develop a system platform to support future applications of the MIST Therapy system. They chose to partner with Logic PD (Minneapolis, MN) to help design, engineer, and manufacture their next-generation device and platform to easily transition the treatment to new markets and improve therapy efficacy.

A Major Redesign--and More

The Logic PD design team began in the discovery phase by working with the device's maker to conduct a study of competitive and analogous products to get a sense for the opportunities and expectations of the device. Field observation activities were conducted at several healthcare facilities to learn about healthcare professionals and patient experiences with the existing product.

These exercises included a workflow assessment that identified the need to move the display on the console to a new pistol grip-style treatment wand. By moving the user interface to the treatment wand, the user could focus on the patient without having to look over their shoulder at the console, improving the patient experience and ease of delivery of the therapy. The redesign also moved the saline control function to the treatment wand, providing clinicians with better control over the precise delivery of the treatment.

Creating a new system platform began with the design of the ultrasonic driver board, which interfaces with what is now Alliqua's ultrasonic transducer assembly used to deliver the therapy. The system's electronics (software and hardware) were developed for improved control and greater flexibility while allowing more efficient driving of the transducer assembly. Furthermore, a tightly coupled feedback loop allowed the ultrasonic driver board to ensure the device kept within the specific resonance required for optimum functionality. By creating a more efficient system, Celleration and the Logic PD team could reduce the cable size, making the treatment wand more ergonomic and easier to use. Engineers also developed the ultrasonic driver board to be modular to support a range of power levels and frequencies so the treatment can be integrated into new applications and markets efficiently.

Monitoring reuse of equipment and disposables was another major challenge, as it is with most medical device companies. To deter the reuse of the custom applicator, the Alliqua and the Logic PD team selected a short-range radio frequency identification tag (RFID) technology for use with each disposable applicator. The treatment wand reads the RFID tag prior to use and writes to the tag during treatment. Therefore, if a used applicator is placed on the treatment wand a second time, the system will disable itself and will not function until a new applicator is inserted, reducing the potential for reuse of the applicator and misuse of the product.

Verifying a New Technology's Commercialization Prospects

Throughout design and development Celleration was engaged with the Logic PD new product introduction and manufacturing teams. This collaboration ensured that the final solution was optimized for ease of manufacturability and release into the marketplace. The Logic PD team worked with critical suppliers to select the right components and resolve any issues throughout the process to create a smooth transition from development to manufacturing. The product was successfully launched into production and the first completed units were delivered in the fall of 2014.

The UltraMIST is a Class II next-generation MIST Therapy platform device that responds to modern healthcare demands. As the cost of treating chronic and non-healing wounds spirals ever upward, technologies such as the UltraMIST System that help reduce the time to heal are becoming more valuable as a way to reduce these costs and improve quality of care.

After months of development and testing, Celleration received FDA clearance for the new UltraMIST Therapy system launched the product into the wound care market in March of 2015. With Alliqua, Logic PD continues to help manage the supply chain for the UltraMIST Therapy system to proactively address issues to ensure continued on-time delivery of completed units.

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