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Orthogonal

Orthogonal

Software Development

Chicago, IL 4,926 followers

Accelerating SaMD Development to Improve Patient Lives | ISO 13485 & HIPAA Certified | Class I-III Device Experts

About us

Orthogonal accelerates the development of Software as a Medical Device (SaMD) and connected devices that improve patient outcomes. As a specialized software development consulting firm, we help MedTech companies bring SaMD, digital therapeutics (DTx), and connected medical device systems to market faster and more efficiently. We combine modern software development approaches - including Agile, Lean Startup, and DevOps - with deep expertise in medical device regulations and safety requirements. For nearly 15 years, we've partnered with industry leaders including Medtronic, Eli Lilly, Google, and Bose to successfully launch innovative medical technologies that make a difference in patients' lives.

Website
https://orthogonal.io
Industry
Software Development
Company size
11-50 employees
Headquarters
Chicago, IL
Type
Privately Held
Founded
1998
Specialties
Medical Software Development, Agile Software Development, User Experience Design, Regulatory Compliance, Healthcare Data Analytics, Lean Innovation, Data Visualization, Customer Acquisition and Retention, User Experience & Human Factors, Medical Mobile Application Development, iOS & Android, Cybersecurity, Digital Health, Bluetooth & Cloud Connectivity, FDA & EU Compliance, AI Algorithms, Patient Engagement & Analytics, 13485, 62304, Digital Therapetuics (DTx), Software as a Medical Device (SaMD), Connected Medical Devices, Cloud Computing, and Patient Engagement

Locations

  • Primary

    222 West Merchandise Mart Plaza

    Suite 228

    Chicago, IL 60654, US

    Get directions

Employees at Orthogonal

Updates

  • At the LSX World Congress in Boston, Orthogonal’s Randy Horton spoke with Darwin Shurig, Founder of Top Talent Accelerant, Inc.. Darwin shared how branded candidate portals, video, and cultural assessments can: ✅ Boost offer acceptance rates to 94% ✅ Improve retention and promotion rates ✅ Save hiring managers from wasted interviews ✅ Shift focus from skills alone to mission and culture fit He also reflected on the tough MedTech hiring market of recent years, why it’s finally showing signs of recovery, and how AI in recruiting can help or hurt, depending on how it’s used. Read the full article here: https://lnkd.in/gmDqdQVM 

  • We’re excited to have Mike Alvarez, CEO of Glooko, join our December 17 webinar on what MedTech teams learned in 2025 and how they’re planning for 2026. We recently spoke with Mike as part of our MedTech Spotlight Live about what it takes to scale a regulated SaMD platform across more than 35 countries, 22 languages, and millions of patients. You can read/watch the interview here: https://lnkd.in/gN3YHSnU His experience running the world’s largest diabetes data platform offers a clear view into the operational and regulatory complexities behind global digital health. He brings experience in: 🔹 Scaling global digital health platforms 🔹 Turning device, cloud, and data strategies into real products 🔹 Leading teams through shifting operational demands 🔹 Keeping innovation steady without losing discipline Mike will share what he saw across the industry in 2025 and what he believes will shape digital priorities in 2026. Save your seat: https://lnkd.in/gxJJrCPt

  • What if routine cervical cancer screening could happen at home with no stirrups, no clinic visit, and no barriers? At the LSX World Congress in Boston, Randy Horton spoke with Trena Depel, VP of Regulatory, Clinical, and Quality at Teal Health, for our MedTech Spotlight Live series. Teal Health developed an FDA-approved at-home self-collection device for cervical cancer screening, supported by telehealth services that guide users from prescription to results. Trena shared: 🔹 Why 1 in 3 women still delay or skip cervical cancer screening and how at-home testing can change that. 🔹 How FDA collaboration and a de novo approval created a new pathway for at-home molecular devices. 🔹 Why early engagement and human-factors testing are key to safe, effective home use. Her insights show how patient-centered design and regulatory transparency can expand access to life-saving care. Read the full article here: https://lnkd.in/e6wSYpdD

  • We spent the past few weeks connecting with people who are doing thoughtful work in SaMD and MedTech. Here are the highlights: 🔹 How teams get real value from AI when they define its role, validate behavior, and keep human judgment close. 🔹 Jenny Barba’s take on early-stage MedTech and why capital-efficient milestones paired with regulatory depth matter. 🔹 How Australis Scientific moved clinic-grade PTNS into daily life with careful engineering and real-world data. 🔹 Highlights from our DC MedTech Roundtable where leaders compared notes on SaMD and digital ecosystems. 🔹 How 👩🏻💻 Beth Arnold guides teams through complex digital health work with service experience and a people-first approach. 🔹 Why cybersecurity strengthens MedTech when treated as core architecture, including insights from Randy Horton on secure updates. These conversations point to a common theme. Building thoughtful digital ecosystems helps teams move with clarity and support safer connected products. Read the full newsletter here: https://lnkd.in/gsu32QP6

  • A therapy that works shouldn’t be held back by the way it’s delivered. That’s what Australis Scientific’s CEO, Nicky Agahari, and CTO, Martin Jensen, kept seeing with Percutaneous Tibial Nerve Stimulation. The treatment helped people, but the weekly clinic visits made it hard for many to stay on track. They set out to fix that and created a discreet, waterproof patch that lets patients use the therapy at home. Their personal experiences with incontinence pushed them to design something that fits into real life. Here’s what makes their approach stand out: 🔹 A microarray needle array that uses far less power while staying clinically accurate 🔹 A wearable patch that blends into daily routines 🔹 Software and cloud infrastructure built for compliance, scale, and real-world data It’s an example of how patient stories and thoughtful engineering can turn a proven therapy into something more accessible. Read the full article: https://lnkd.in/g-W5rF-m 

  • 🌟 Spotlight on 👩🏻💻 Beth Arnold, Delivery Manager at Orthogonal Beth’s path into tech is anything but conventional. After years in service and operations roles, she gradually taught herself full-stack development and later made the leap into software during the 2020 pandemic. That mix of people-focused experience and technical curiosity eventually led her to Orthogonal, where the Delivery Manager role matched both her strengths and her interest in work that genuinely helps patients. At Orthogonal, Beth supports teams building Software as a Medical Device (SaMD), bringing clarity, leadership, and a thoughtful approach to problem-solving. She’s especially interested in how emerging technologies can support clinicians and patients when used responsibly. With close family members working in healthcare and others managing chronic conditions, the impact of this work is personal for her. Outside of work, Beth leans into creativity and comfort, reading nearly 90 books this year, spending time on digital coloring, and developing ideas for her “productverse”. She’s also rarely without Yogi, her 100-pound doodle who joins her for most workdays and provides companionship. Beth, we’re glad to have you on the team and appreciate the heart, thoughtfulness, and leadership you bring to Orthogonal!

  • Millions of women silently endure treatable pelvic floor conditions. Materna Medical is changing that. At the LSX World Congress in Boston, Orthogonal’s Randy Horton spoke with Tracy MacNeal, CEO of Materna Medical, about innovations in women’s pelvic health, as part of our MedTech Spotlight Live. Highlights from the conversation: 🔹 Milli: patient-controlled expanding dilator for vaginismus; modernizes a 19th-century approach. 🔹 Ellora: used in active labor to prevent pelvic floor injury; expands only as tissue relaxes and records force data. 🔹 Design refined by feedback from hundreds of patients and thousands of clinicians (e.g., “baby bumper” visual alert). 🔹 First real-world pelvic floor force curves, enabling better education and future predictive models. Read the full article: https://lnkd.in/g3tEUsz9 

  • Many MedTech teams started 2025 with clear digital plans. By the end of the year, those plans often shifted. Device functionality improved in some areas, cloud capabilities matured, and a few unexpected workstreams kept teams busier than they expected. On December 17 at 11 AM CT, Orthogonal is hosting “Lessons Learned from 2025, Plans for 2026 for Digital. We’ll take a practical look at what moved forward this year, what forced teams to adjust, and how leaders are shaping their 2026 roadmaps. ✔️ How 2025 digital objectives played out in practice ✔️ Real progress in device, cloud, and ecosystem maturity ✔️ Challenges that reshaped priorities ✔️ Work that surfaced unexpectedly ✔️ What leaders would do differently in hindsight ✔️ How lessons from 2025 are shaping next year’s plans If you’re preparing for 2026 and want a grounded read on where digital work is headed, this session will help clarify the path. Save your seat!

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  • For millions with Restless Leg Syndrome (RLS), sleepless nights can last for years. At the LSX World Congress in Boston, Orthogonal’s Randy Horton spoke with Shri Raghunathan, CEO of Noctrix Health, Inc., for MedTech Spotlight Live about Nidra, a FDA-cleared wearable therapy bringing relief to RLS patients. Interview highlights: 🔹 How Nidra uses gentle neurostimulation to ease RLS symptoms without drugs. 🔹 Why Shri built a focused digital ecosystem to support patients and track outcomes. 🔹 How Noctrix is leading a real-world study on sleep and quality-of-life improvements. 🔹 Why rigorous science, not shortcuts, drives sustainable reimbursement. Shri’s story shows how disciplined design and evidence-based innovation can turn technology into restorative sleep. Read the full article here: https://lnkd.in/gxzsNAVj 

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