Medical Device Software
Embedded and Stand-Alone Medtech Software Solutions
Software in and as a Medical Device (SiMD and SaMD)
Leveraging agile design, dynamic software development and cutting edge engineering can give medical technology companies a competitive advantage in the increasingly consumer-focused and regulated medtech space.
Nerdery helps medical device manufacturers develop software processes and solutions (software in a medical device, or SiMD) inside and around medical devices that reduce time to market, improve quality, and deliver differentiated value across the entire device lifespan. Nerdery also has experience developing approved stand-alone software and mobile apps that can be prescribed like medications to treat, diagnose, cure, mitigate, or prevent disease or other conditions (software as a medical device, or SaMD) on their own.
Our Medtech Expertise Includes:
Bluetooth Low Energy (BLE) Integrations
From our experience with both proprietary and standard BLE protocols, we know effective integrations with hardware will consider battery consumption, prioritize reliability of obtaining connections, and ensure data is not lost due to unexpected disconnections or lack of internet connectivity.
Security is only as strong as its weakest link, which is often the mobile device. Our team builds in encryption at rest and in transit, and can advise you from our experience with third-party tools that guard against tampering.
Process and Testing
We adapt and align our processes with the clients’ to achieve the best outcomes within complex requirement structures and reporting, including supporting the necessary steps for the validation of testing/reports required for FDA 510k, Class I and Class II approvals to meet IEC 62304 and other standards. Nerdery also helps clients redesign their own R&D processes through business process redesign, agile coaching and embedded collaboration teams.
Mobile User Experience Design
Our native mobile design specialists will help you take advantage of iOS and Android capabilities while offering best-in-class user experience and future-thinking functionality. We’ll bring your innovation to life while also considering maintainability, usability and accessibility.
Mobile Engineering and Accessibility
We’ve been developing mobile apps since smartphones entered the market, with expertise in integrating proprietary and standard BLE protocols, offline usability, understanding of background behavior and experience meeting test coverage and traceability requirements. Nerdery will help you take full advantage of iOS and Android accessibility tools and best practices to ensure your app meets WCAG AA / AAA guidelines.
Our IoT-enabled solutions automate data transmission so physicians and clinicians can access data quicker and earlier with the goal of improving device users’ outcomes through remote patient monitoring.
Get started with embedded and stand-alone medical device software.
Transforming Patient and Clinician Experiences
We partnered with a leading medical device company to offer patients a better experience when tracking cardiac symptoms. Our app pairs with an implantable Bluetooth cardiac device that tracks a patient’s heart rhythm and transmits it to their doctor, along with any logged symptoms. A carefully designed setup process and simple, easy-to-use daily experience builds confidence in patients, even if they are otherwise unfamiliar with using a smartphone.