Orthogonal

Ready to level up your QMS—fast? metaMe Health tapped Orthogonal’s expertise to streamline their #QMS creation and accelerate their path to greater productivity. For growing #MedTech teams, it’s a strategic shortcut to both compliance readiness and forward momentum. Danny Bernstein #medicaldevice

When big tech companies need help with the details, they come to Orthogonal. We engaged in #UX Design and #HumanFactors work that met the needs of parents of newborns for our client’s infant jaundice diagnosis app. That’s how we help #medicaldevice companies of all sizes design products that fit seamlessly into users’ lives.

?? Redefining Emergency Medicine: AI-Driven Innovations in Real-Time Data Capture At the 2025 MD&M West Conference in Anaheim, the MedTech Spotlight Live videocast brought insights from industry leaders. We sat down with Rachel Wong, a seasoned veteran with a rich biomedical engineering and R&D background from St. Jude Medical and Inari Medical. Now, venturing into AI-driven emergency medicine, Rachel is reimagining how critical patient data is captured and shared. Here’s what Rachel shared: ?? Seamless Data Continuity: Imagine a scenario where a patient’s vital signs, captured by paramedics at the scene of an accident, are instantly transmitted to the receiving hospital. This real-time data flow bridges the communication gap and ensures physicians get a complete picture even when every second counts. ?? Transforming Battlefield Medicine: In high-stakes environments with limited medics, streamlined data capture enables medics to focus on immediate patient care. Rachel’s approach could be a game-changer in ensuring swift, accurate treatment from the point of injury to the ICU. ?? User-Centric Design in Challenging Environments: With a UI/UX optimized for dark settings, think color-coded displays visible even in low light. This innovation minimizes cognitive overload, ensuring medics can operate in austere environments. How do you see AI transforming the emergency medicine landscape? #MedTech #AI #MedicalDevices

? FDA PCCP for AI/ML Medical Devices Webinar TOMORROW! Join Orthogonal and industry experts for a deep dive into Predetermined Change Control Plans (PCCP) for AI/ML medical devices! Key takeaways: ?? PCCP essentials: Simplify AI/ML device regulatory submissions ?? Leverage PCCP for AI/ML updates without full resubmission ?? Real-world PCCP implementations in medical devices ?? Latest FDA guidelines for AI/ML software updates Why join? ?? Get actionable PCCP strategies from industry veterans ?? Stay ahead of evolving FDA regulations ?? Live Q&A with Brendan O’Leary & Megan Graham Don’t let regulatory complexities slow your innovation. Join us to understand PCCP and accelerate your AI/ML device approvals! ?? Last-minute registration: https://lnkd.in/giga-fGe #SaMD #MedicalDevices #FDA #PCCP #Webinar

?? Spotlight on Randy Horton, Chief Solutions Officer at Orthogonal ?? Randy’s tech journey began at the dawn of the internet, and for over two decades, he’s helped organizations navigate “what’s next” with a strong focus on healthcare. After first crossing paths with Orthogonal’s founders as a customer, he officially joined five years ago to accelerate our mission of Improving Patient Outcomes Faster. At Orthogonal, Randy plays a key role in bringing Software as a Medical Device (SaMD) solutions to market and co-chairs an AAMI standards Working Group on safe cloud computing for medical devices. He believes healthcare must shift from traditional “points of care” to “points of living,” where people manage health anywhere, enabled by AI and digital tools. Outside work, Randy stays curious by attending conferences, mentoring startups, and even diving into a new passion: postcards. He sends one daily to his kids who’ve “grown and flown,” fascinated by how postcards were the original social network. He’s also a movie buff and a full-time emotional support human to a very affectionate dog. A natural problem-solver, Randy thrives in complexity and embraces a “no box” mindset to tackle MedTech’s biggest challenges. His motto is Move Faster. Break Nothing. Randy, we’re grateful for your leadership, insight, and relentless drive to push boundaries in MedTech. #EmployeeSpotlight #TeamOrthogonal #MedTech #SaMD #AIinHealthcare #Innovation

As the MedTech industry continues its digital transformation, effectively leveraging data has become a requirement. At our January webinar, industry leaders shared insights on best practices for using data to drive efficiency, innovation, and regulatory compliance in medical device software development. Key takeaways from our discussion: ?? Digital transformation in MedTech is now a competitive necessity, not an option. ?? Successful companies will treat data as a core asset, not an afterthought. ?? Regulatory navigation requires both technical expertise and proactive engagement. ?? Investing in software talent is crucial for long-term success. ?? Innovative business models are redefining how MedTech companies generate value. #MedTech #SaMD #MedicalDevices Venk Varadan (Nanowear), Bernhard Kappe (Orthogonal), Randy Horton (Orthogonal)

Arriving at the right design for your #medicaldevice software requires thoughtful iteration. Orthogonal’s Agile development methods allowed us to quickly identify the best image collection method for our client’s #MachineLearning diagnostic algorithm. For #MedTech companies embarking on clinical trials, we create software systems designed for usability and efficacy.?

Join Megan Graham, Orthogonal’s VP of Regulatory & Quality, to learn how PCCP slashes submission timelines and budgets for AI/ML devices. She brings 25+ years of software and regulatory expertise to the table. Megan will share insights from her extensive experience in: ?? Navigating complex AI/ML regulatory landscapes ?? Developing effective risk management strategies for digital health ?? Balancing innovation with regulatory compliance Don’t miss out! Register Today: https://lnkd.in/giga-fGe #SaMD #MedicalDevices #FDA #PCCP #Webinar

Last week at Maggiano's Little Italy in Boston, during the THT conference, we had the privilege of hosting an incredible roundtable dinner alongside Ami Bhatt, MD, Chief Innovation Officer of the American College of Cardiology and Akshay Desai. It was an evening of open, insightful conversation as we reflected on the evolution of digital cardiology, the challenges of scaling innovation, and the barrier to integrating data, connectivity and workflow solutions into patient care. Key Takeaways from Our Discussion: ?? The Evolution of Digital Cardiology – Early experiences with telemedicine trials and handheld ultrasounds paved the way for today’s digital cardiology, showing how technology has steadily become essential to patient care. ?? From Prototype to Scalable Solutions – While early digital health innovations generate excitement, the real challenge lies in sustaining long-term engagement and successfully scaling solutions to have a lasting impact. ?? Data Integration & Democratization – Home-based data collection has potential, but trusted clinical insights still come from large hospital systems, leaving smaller or rural practices at a disadvantage. Closing this gap remains a critical priority. ?? Connectivity, Access & Policy Issues – While many underserved populations actively use smartphones and digital platforms, policy and infrastructure challenges, such as bandwidth limitations, continue to hinder effective adoption. ?? Engagement, Workflow Integration & Patient Advocacy – For digital health solutions to be effective, they must seamlessly integrate into clinical workflows, provide actionable insights, and prioritize patient advocacy to ensure technology serves real needs. A huge thank you to everyone who joined us and contributed to this engaging and thought-provoking discussion. The exchange of insights was invaluable, and of course, the food and company made it even better! We look forward to continuing the conversation and driving meaningful progress in digital cardiology. Venk Varadan, Mary Aggarwal, Samir Awasthi, Juuso Blomster, Alexander Blood, MD, MSc, FACC, Don Crawford, Moha Desai, Jeff Gombala, Martin Gomez, Kim Guibone DNP, APRN, FACC, Raghav Gupta, Jennifer Joe, MD, Patricia Keegan, Giovanni Lauricella, Olivia Lew, Andrew Marshall, Peter Meyer, Maitri Patel, PharmD, BCACP, Sasha Khursheed Said, Himabindu (Hima) Vidula, Amir Z., Randy Horton, Bernhard Kappe, Ben Trombold, MBA #Cardiology #MedTech #DigitalHealth

Excited to share insights from our recent MedTech roundtable dinner at Il Fornaio Beverly Hills, co-hosted with MedTech Impact Partners. This gathering brought together brilliant minds from across the MedTech industry for a night of great food, stimulating conversation, and invaluable insight sharing. Here are the key takeaways from our discussion: ?? Regulatory Guidance & Information Overload: Constant FDA updates can be overwhelming, so many of us use focused weekly catch-ups and selective news intake to filter the “noise.” ?? Med Devices Outlook: Strong FDA relationships give us confidence that medical devices will face only minor tweaks compared to sectors like pharma or food. ?? Generative AI Integration: Companies are leveraging AI using high-performance GPUs, tools like Microsoft Copilot, and internal AI sandboxes to boost product development, streamline operations, and even improve internal communications. ?? Global Operations & Supply Chain Resilience: With potential tariff increases and supply chain challenges, there’s a growing need to rethink sourcing strategies and balance work models between in-office and remote arrangements. ?? Enhancing Patient Outcomes: Innovations such as sensor-enabled implants for post-surgical monitoring and the ethical use of anonymous patient data are key to driving real improvements in patient care. A heartfelt thank you to all participants and MedTech Impact Partners for their partnership. Sonal Matai, Jaime Wheeler, MBA, CPhT, Juliana Elstad, Bisrat Woldemichael, PhD, Dan Gober, Yael Swerdlow, Naresh Menon, Kwame Ulmer, Cyrus Safavi, Jeremy Koff, Jessica Jung, CSPO, CSM, SA, Nima Shiva, Christian Johnson, Natasha Lepore, Randy Horton, Ben Trombold, MBA #MedTech #MedicalDevices #SaMD