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Helping to heal patients with ultrasonic therapy.

ALLIQUA BIOMEDICAL // UltraMist

This wound care solutions company came to Logic PD to design, develop and manufacture their next generation ultrasound treatment device. Leveraging Logic PD’s user-centered approach and ultrasonic capabilities the team created the UltraMIST therapy platform that is easier to use, more efficient, and helps to reduce the time it takes to heal chronic wounds.

CHALLENGE

Alliqua BioMedical is known for developing advanced wound care solutions including MIST® Therapy, a painless ultrasound treatment that accelerates the natural wound healing process. The low-frequency ultrasound of MIST Therapy has been clinically proven to stimulate cells within the wound to promote pain free healing. With a plan for expansion into new applications and new markets, Alliqua knew they had to address different user and business needs while creating an updated platform for growth. To accomplish this they required a well-integrated product realization team to develop a system platform to support future applications of the MIST Therapy system. Alliqua chose to partner with Logic PD to help design, engineer and manufacture their next generation device and platform to easily transition the treatment to new markets and improve therapy efficacy.

SOLUTION

The Logic PD design team began in the Ideation and Discovery stage by working with Alliqua to complete a study of competitive and analogous products to better understand 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. From these exercises, Alliqua and the design team were able identify requirements for the redesign of a new pistol grip style treatment wand. This included a significant workflow assessment which pointed to the need for the display on the console to be relocated to the 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 Alliqua’s Ultrasonic Transducer Assembly used to deliver the therapy. The system’s electronics (software and hardware) were developed using an innovative technology 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, Alliqua 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.

Like most medical device companies, monitoring reuse of equipment and disposables is becoming a big challenge. To deter the reuse of the custom applicator, Alliqua and the Logic PD team selected a short range radio frequency identification tag (RFID) technology that would be used 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.

Throughout the Development phase Alliqua 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 to Alliqua in the fall of 2014.

RESULTS

The Logic PD team helped Alliqua to create UltraMIST® a Class II next generation MIST Therapy platform device that is easier to use, more efficient, and provides opportunities for growth and expansion. As the cost of treating chronic and non-healing wounds continues to grow, technologies like the UltraMIST System that help reduce the time to heal are becoming increasingly more valuable as a way to reduce these costs and improve quality of care.

The UltraMIST System offers clinicians a pistol-grip treatment wand and smaller cable to make the user experience and delivery of the treatment easier and more precise. Additionally, the display was moved to the treatment wand eliminating the need to look back at the console and full attention can be on the patient and the treatment area. The development of the new Ultrasonic Driver Board provides the capability and flexibility to allow for use in other therapies and can be used in a wider range of applications than ever before. After months of development and testing, Alliqua received FDA clearance for the new UltraMIST Therapy system launched the product into the wound care market in March of 2015. 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.

CUSTOMER PROFILE

Alliqua BioMedical is a leading provider of advanced wound care solutions. The company’s focus is to provide physicians and practitioners with a greater ability to deal with the challenges of healing both chronic and acute wounds.

The UltraMIST and MIST Therapy systems were developed by Celleration, Inc. Celleration has since been acquired by Alliqua BioMedical in June of 2015.

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