LivaNova [NASDAQ:LIVN]

Marco Dolci

Medical device companies face an interesting challenge when approaching product innovation. How do they innovate in a truly meaningful way to address the evolving needs of their customers while honoring the legacy and historical success of their signature products? Companies have traditionally involved the customer at some point in product development, however it has tended to be during the final phases of development when testing occurs. What if companies employed a broader approach that made the end user a focal point in all phases of the development process – from product ideation to final delivery?

LivaNova, a global market leader in heart-lung machines and cardiopulmonary equipment for nearly 50 years, is one company that recently employed this emerging, comprehensive “user-centric design” approach. One of its primary customer groups – or users – are perfusionists, who play a critical role on cardiac surgery teams. They ensure patients receive proper support from extracorporeal devices to maintain vital functions during a procedure.

As the company looked to upgrade and advance its cardiopulmonary platform, LivaNova asked an important question, “How do we elevate a perfusionist’s clinical wisdom as a more vital component within the operating room (OR)?” The company knew this would have to be more than a system upgrade. Employing a comprehensive, user-centric design approach, LivaNova worked hand-in-hand with more than 300 perfusionists worldwide during every step of development to address their changing needs in the OR, with an emphasis on patient safety and risk management.

The first step was an in-depth discovery phase, where perfusionists participated in one-on-oneinterviews, focus groups and surveys to offer open and honest conversation with the LivaNova product development team. The perfusionists weighed in on everything — from the smallest ergonomic details to ensure the proper visibility of the operating field to complex software data management features. In short, LivaNova gave perfusionists a blank piece of paper to share their experiences, minimum requirements and ultimate desires.

Among all the feedback collected during the discovery phase, “access to comprehensive data”reigned supreme – a must for perfusionists to make more informed decisions that fuel improved and individualized health outcomes for patientsduring life-saving procedures. Perfusionists are commonly quiet enablers in the OR. But with advanced data, they can be critical contributors to successful patient outcomes.

Understanding this vital need for data, LivaNova moved into the design phase. The main goal was always to build on the existing features of previous generations of the Company’s heart-lung machine, while adding a layer of advanced technology and intelligence to improve the user experience. The company asked perfusionists to get creative and build the new system using cardboard boxes, Post-it notes and virtual reality. As LivaNova finished hardware and software prototypes, perfusionists challenged the creations. As a team, the company and the perfusionists derived hundreds of ideas on how to improve the existing cardiopulmonary platform and worked jointly to test each one.

“ This approach – involving the end user throughout all stages of the development process – has the potential to become a new standard within the medical device industry ”

LivaNova believes the Essenz platform would not be developing into what it is today without the very intentional, comprehensive, user-centric design strategy. LivaNova knew perfusionists would more than likely enjoy a seat at the design table. Their willingness to participate and their level of openness far surpassed company expectations. The result will be the Essenz™ Perfusion System, which aims to combine the power of data with intuitive technology and a fully supportive service proposition. Essenz is in final stages of development and will soon be launched, after receiving appropriate regulatory approvals.

This approach – involving the end user throughout all stages of the development process – has the potential to become a new standard within the medical device industry. It transcends simply approaching a customer to sell a product with tangible components. Rather, it advocates a point of view and strengthens relationships between manufacturers, clinicians and hospitals. Ultimately, it results in all parties collaborating to attain the most important, shared goal – offering patients the best possible outcomes during life-saving cardiac surgery procedures.

Marco Dolci leads the Cardiopulmonary business unit for LivaNova. He joined the company in 2017. Dolci has more than 30 years of experience working in the healthcare and medical device industries.

The Essenz™ Perfusion System is not available for sale. It is currently in development and is intended to be approved by relevant authorities Information around the Perfusion System is only available in selected geographies.