SaMD development @ warp speed

2022 has been a wild, unpredictable and eventful year in the history of Dawn Health. As a company we have leapfrogged from a small and specialized digital health start-up to a product-based global scale-up with accomplishments that speak for themselves:

• +100 new colleagues in 2022
• Incorporation of Dawn Health in Switzerland
• Significant new partnerships with Global Big Pharma
• Four quality audits from BSI notified body = 0 nonconformities in total
• Scaling our regulated Dawn platform to deliver SaMD products @ warp speed
• Submission of regulated SaMD products under EU MDR (celebration video below ??)

At the doorstep to 2023, digital health is at an inflection point where macro trends enable a shift in patient care from clinic to remote. Science and technology are merging and continuously expanding our care continuum.

Expectations for digital empowerment in healthcare is no longer nice-to-have but the norm and requested from all stakeholders in the disease eco-system.

In 2023, delivery mechanisms of Drugs will be empowered by novel Devices, Digital Interventions (DTx/SaMD), advanced Diagnostics and Data strategies driving real-world evidence to unlock value-based contracting.

At Dawn Health we are confident that medicine will increasingly become digitalised to support enhanced patient outcomes. To meet growing industry demands and support our life science partners, we have invested heavily in an innovation endeavour to transform the way we support patients in the future.

The Dawn Platform is a robust and regulated platform that accelerates speed to market of SaMD products from years to months, while ensuring full compliance with regulatory requirements from European notified bodies and the FDA.

The main components of our platform engine are the following:

1. Pre-qualified SaMD software modules ready for scale
2. Fully-fledged automated testing regimens of all SaMD modules
3. Continuous deployment driving agile SaMD development @ warp speed
4. Automated SaMD documentation for submission to competent authorities
5. ISO13485:2016 certified QMS infrastructure with Dawn as a Legal Manufacturer

The Dawn Platform will democratise access to regulated software development and support best-in-class products to drive clinically validated remote data points. This includes passively flowing data, patient support programs, integrations to in-clinic data, IoT connectivity, digital biomarkers, ePROs, sophisticated dosing algorithms and virtual clinic capabilities.

A central part of our platform is the advanced decision support engine for analysis of collected data to track disease progression, while supporting remote patient triage and enhancing clinicians in delivery of personalised medicine. In 2023, we look forward to deploy this engine to support patient pathways for people living with type 2 diabetes, multiple sclerosis and cardiovascular disease ????

Growing a company with +350% headcounts in less than a year has been an experience beyond the ordinary. Looking back I am proud that we have managed to maintain our culture and expand the size of our team with an untouched family spirit and a shared passion for the company vision “Code To Save Lives”.

The combination of excellent people, strong culture and competencies across quality, regulatory, software development, product strategy, design, research, clinical evaluation, marketing, business development, usability engineering, operations, post-market surveillance and medical affairs has allowed Dawn Health to excel within digital health and deploy numerous impactful solutions to aid people living with serious chronic diseases. This is the reason why we exist, and this is exactly why we come to work ignited by an unparalleled motivation to drive change in healthcare - day in and day out.

On a personal note, I experienced the greatest joy in my life on October 18th when my girlfriend Trine gave birth to our son William ??

Words cannot describe the wonders of parenthood and the love that bubbles in my heart when looking into the eyes of my newborn son. In 2022, more than 10 colleagues in Dawn Health became parents and it’s simply amazing to see new life blossoming as our company expands in size.

Becoming a parent intensifies both my private aspiration and our corporate ambitions to secure a better world for future generations. As an organization we are deeply committed to ESG and sustainability. Therefore, I’m pleased to announce, for the second year in a row, that Dawn Health has successfully fulfilled our commitment of having zero environmental impact via reductions in our carbon footprint and a strategy to offset 100% of our Co2 emissions - achieved via carbon offsetting projects in China and Madagascar.??

Combined with a strong corporate performance in growth of 333% since the origin of our company, it makes me proud to be part of a phenomenal and purpose-driven Danish company that deliver sound results across social, environmental and economic verticals.

We simply cannot wait to announce BIG news in 2023 on strategic partnerships that will allow Dawn Health to develop novel new digital health products targeting people living with multiple sclerosis, cancer, cardiovascular disease, hypoparathyroidism, COVID-19 and a larger portfolio of neurological illnesses.

Thank you to all who follow our journey, to our consortium of investors, to all our outstanding colleagues in Dawn Health and not least to our amazing partners in the life science industry.

Best wishes of a Festive Holidays Season and a Happy New Year. See you in 2023 ??

Dawn Health?“Code to Save Lives”