How Sofwave Implemented a Cloud-Based Proactive Postmarket Surveillance Method and a New Business Model - 'Pay Per Pulse' - Securely Through BioT

Dermatology tech innovator and multiple award winner, Sofwave™, has developed a breakthrough technology for lifting the eyebrow, submental, and neck, and reducing fine lines & wrinkles, as well as mitigating cellulite artifacts. Its Synchronous Ultrasound Parallel Beam Technology, which is FDA and CE cleared, revitalizes the skin through the stimulation of the production of new collagen.

‍

Scaling to Full Commercialization

To propel the company to the next level of commercialization, Sofwave's vision was centered on transforming the standalone Sofwave machine into an edge component within a global connected Sofwave system. This interconnected platform caters to a diverse range of users, including patients, dermatologists, clinic supervisors, and Sofwave's internal regulatory, operations, business, and data analyst teams.

For the regulatory and operations users, an end-to-end solution for proactive postmarket surveillance was essential. This involved constant monitoring of the machine's activity and integrity, as well as the capability to deploy immediate fixes through remote software updates and/or remote configuration. Additionally, tracking treatment efficacy through automated analysis of incoming patient data and correlating it to the machine's activity on the patient was deemed critical.

Addressing the needs of business users, Sofwave sought an automated pay-per-pulse business model. The solution needed to seamlessly span from the online e-store where pre-paid usage licenses are purchased to the system backend, where alerts on low levels are managed, and further extend to the machine, ensuring reliable loading of new licenses.

For their data analysis efforts, they pursued an ability to collect and visualize business intelligence (BI) insights.

‍

The Challenge

Sofwave faced the imperative of fully capitalizing on their time-to-shine window as a cutting-edge groundbreaking technology, making time to market a major concern. However, they understood that developing the necessary functionality to cater to patients, dermatologists, clinic supervisors, and their internal regulatory, operations, business, and data analyst teams would be a time-consuming process.

Recognizing the importance of not only delivering a minimal viable product (MVP) solution on time for launch but also designing for future scalability, Sofwave sought an architecture that could guarantee short development timelines for both initial and subsequent evolutions. They understood that their system needed to serve them for many years to come, evolving with advancements in technology.

Regulatory compliance and cybersecurity posed significant risks. Being a class II medical device provider, Sofwave required a cloud solution that would adhere to worldwide regulations, including HIPAA, GDPR, FDA, MDR, and others.

Initially, building the infrastructure in-house seemed like an option, but Sofwave swiftly realized it was not efficient for several reasons. It would cause delays in time to market due to building from scratch, and the system would face cybersecurity and privacy risks during its early stages. Moreover, it would divert the focus of R&D efforts from creating data-driven unique value propositions for patients and dermatologists to building infrastructures.

Instead, Sofwave sought an existing platform that could help them rapidly construct a state-of-the-art, fully-fledged, connected therapy system. They needed a platform that met their specific requirements, which included:

• Compliance with all necessary regulations.
• Postmarket Surveillance modules for tracking device activity.
• Managing a large volume of incoming data as log files for analyzing operational and treatment efficiency.
• Support for a pay-per-use business model.
• Firmware update capabilities.
• Proven scalability.

‍

The solution

‍Sofwave made the strategic decision to leverage BioT's unique self-service IoMT platform to build the global Sofwave system. BioT stands as an open regulated platform for constructing cloud-powered medical devices, offering ready-to-use cloud-based medical device modules in four categories: postmarket surveillance, patient outcomes, clinical evidence, and business operations. By leveraging these modules, Sofwave could swiftly create end-to-end digital health solutions for medical devices, all while ensuring a secure, robust, scalable system that complies with global regulations now and in the future.

In addition to the benefits of ready-to-use modules, BioT introduced a groundbreaking 'no-code' interface to the regulated medical device space. Through BioT's drag-and-drop administration console, users could teach the platform about their device and ecosystem data model in less than a day. This technological breakthrough significantly reduced the time required to build medical-grade compliant cloud-based devices compared to other methods.

With BioT, Sofwave experienced significantly reduced in-house development efforts and associated costs, as well as ongoing expenses related to maintaining a medical-grade system in a rapidly changing cyber-threatened environment. Notably, no cloud DevOps expertise was required when building on BioT.

By partnering with BioT, Sofwave's team was relieved of the day-to-day maintenance of cybersecurity, regulatory compliance, and high availability. BioT's expert team is continuously monitoring changes in the regulatory and cybersecurity landscape, ensuring that the BioT platform is consistently evolving to meet these challenges. Erez Panir, R&D Director at Sofwave, expressed, "You can develop anything in-house, but don't bury your head in the sand – our product is not a mere proof of concept. With regulation, cybersecurity, and scalability in mind, you may encounter complex challenges that you are unsure how to overcome. Where instead you can opt for something reliable and much more cost-effective. The risks involved are not worth it."

To deliver the ultimate cutting-edge experience to its customers, BioT's software leveraged the AWS cloud. The breadth of cybersecurity and data privacy regulations AWS complies with worldwide empowered BioT to prioritize the security and privacy of the BioT medical device application modules themselves, without having to worry about the cloud infrastructure.

‍

Results

BioT's solution empowered Sofwave to realize its vision of a global Sofwave system, delivering value to patients, dermatologists, clinic supervisors, and Sofwave's internal regulatory, operations, business, and data analyst teams.

By providing an out-of-the-box cloud solution that perfectly matched Sofwave's requirements, BioT enabled the company to accelerate its time to market almost instantly. The highest level of regulatory compliance, medical-grade cybersecurity, and ongoing device and cloud management from BioT alleviated much of the regulatory burden for the Sofwave team.

BioT's proactive postmarket surveillance modules provided Sofwave with valuable insights into how their devices were being used in the field, offering a systematic, non-anecdotal approach.

"The BioT platform's proactive Post Market Surveillance capabilities have made a remarkable impact. With this innovative technology, we have been able to identify potential issues with our devices and swiftly address them." said Panir.

‍

Moving Forward: Growing Partnership

BioT has streamlined Sofwave's efforts in taking the company to the next level of commercialization by transforming the standalone Sofwave machine into an edge component within a global connected Sofwave system.

Sofwave is not content with stopping at the MVP stage. They aim to continue delivering value to patients, dermatologists, clinic supervisors, and their internal teams. Proactive post-market surveillance capabilities, including geo-location and warranty management, are currently in the pipeline.

With the winning combination of their breakthrough skin therapy device, generating unique patient data, and the BioT platform expertly processing it, Sofwave is progressing towards becoming a data company focused on leveraging its vast collected data to drive breakthroughs in skin therapy. Working in partnership with BioT, Sofwave is confident that all their cloud medical device needs will be efficiently handled at every stage, without the need to invest in any in-house infrastructure.

‍