What if your MedTech idea could turn into a certified device in under a year? iOrbit’s 360° ecosystem is striving for that. Bipin R R, Benoy and Sandeep Zende of iOrbit speakers to EFY’s Nitisha Dubey on redefining healthcare through design, AI, cloud and compliance.
Q. Could you give us a brief introduction to iOrbit?
A. iOrbit, founded in 2016 as a private limited company by me and Raji (our Chief Technology Officer), is now in its 10th year of continuous growth. Headquartered in Bengaluru with additional offices in Pune and Thiruvananthapuram, we also have operations in Atlanta to serve the United States (US) market and in Rotterdam for the European Union. As a MedTech-focused product development company, we provide 360-degree solutions spanning medical devices, associated devices, software, cloud, artificial intelligence (AI) integration, regulatory compliance, and certification, driven by our vision of building a strong end-to-end MedTech development ecosystem from India for both domestic and global markets.
Q. What is the idea or vision that led to the name iOrbit?
A. The genesis of the name came from the way we see the future of data in healthcare. Traditionally, data has been entered manually into information technology (IT) systems such as hospital management software and electronic health records. But increasingly, machines themselves are generating and transmitting data directly to the cloud: diagnostic equipment, patient monitors, ventilators, anaesthesia machines in operating theatres, and so on.
So, what we see is a convergence of IT data (from hospital systems) and operational technology (OT) data (from medical devices). Together, they create what we call an ‘intelligent orbit’ of data, enriched further by AI. That is why we named the company iOrbit, as it represents this new intelligent orbit of connected healthcare data.
Q. How do you differentiate yourself from typical product engineering firms?
A. We were very clear from the start that we did not want to be a one-trick pony offering just hardware, firmware, or software. Many firms provide such horizontal services across multiple industries. Instead, we positioned ourselves as domain experts, 100% focused on MedTech, with a 360-degree service model.
Our design division, iZen Design, is completely MedTech-focused. Our hardware and cloud integration capabilities are also specialised for MedTech. We have even achieved our first US Food and Drug Administration (FDA) certification in collaboration with a client, which validates our approach of building certifiable, robust products.
Q. What does this 360-degree perspective look like in practice?
A. Our work spans printed circuit board (PCB) design, electronics blocks, industrial and user experience design, and the companion apps that today’s digital health products require. We also have our own homegrown cloud platform, iTouch, which provides the digital infrastructure for connected healthcare solutions. On top of that, we have a dedicated AI department, ensuring we stay ahead of the curve in applying AI both in our execution and in the products we develop for customers.
Q. Do you take ideas from concept to launch?
A: Exactly. We cover the entire product development lifecycle: electronics and hardware design, firmware and software, cloud enablement, compliance, and certification. Whether it is outsourcing part of the research and development (R&D) or executing the full cycle, our role is to ensure the customer has a market-ready product.
Q. How do you speed up MedTech product development?
A. MedTech products require much more than just electronics. Once the base hardware and electronics are ready, we need industrial design to house the product, cloud-connected software if required, and eventually, clinical validation and regulatory approvals. This makes the cycle extremely long. Our role as an organisation is to provide an end-to-end pathway, right from product design, hardware, and software to certification, so we can accelerate time-to-market for our clients.
Q. Can you give an example of the kind of projects you execute?
A. Recently, a client approached us to design a solution involving bedside monitors connected to electrocardiogram (ECG) patches and wearable sensors. The requirement was to wirelessly transmit patient vitals to a cloud system, allowing continuous remote monitoring. We handled the complete process, including hardware design, software and firmware development, cloud integration, and regulatory documentation, resulting in a certified, ready-to-manufacture product.
Q. Do you also build devices along with iTouch?
A. At present, we do not have a dedicated manufacturing facility. Our core strength is in design and development, and we typically leverage our customers’ or partners’ manufacturing setups to produce the devices. Eventually, having our own manufacturing line is part of our roadmap.
Q. Can you share examples of products you have developed?
A. In cardiology, we have built wireless patient monitoring solutions. In respiratory care, we have designed continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) devices for sleep apnea. We have also worked on fall detection pendants and Wi-Fi-based temperature sensors. Each project has unique complexity, but the approach remains end-to-end.
Q. How do you handle testing and compliance?
A. Beyond performance, safety and compliance are central. Medical devices must meet international standards like International Electrotechnical Commission (IEC) and International Organization for Standardization (ISO), and in some cases, FDA requirements. We conduct internal testing to mitigate risks, and only when products meet every requirement do we release them to customers. To give an example, one of our recent products received FDA clearance, which opened the US market for our client. This process involves rigorous checks on design, risk, cybersecurity, wireless interference, and regulatory compliance.
Q. Do you provide white-label products or market them under your own name?
A. We mostly work as a product development partner. Clients bring us ideas, often from universities or research labs, and we convert them into regulatory-compliant medical products. These are usually white-labelled, with the client owning the brand and handling marketing and production. At present, we do not manufacture in-house, but we collaborate with our ecosystem partners for production. In the future, we may set up our own facility to give clients a one-stop solution.
Q. How do you keep solutions affordable for budget-strained hospitals?
A. Affordability is central to the design approach, achieved by eliminating reliance on costly third-party integrations and instead using a cost-effective in-house hub device. This hub aggregates data across local area network (LAN), Wi-Fi, and Bluetooth protocols and transmits it securely to the cloud. The cloud layer is equally flexible. US hospitals typically prefer Amazon Web Services (AWS), European clients lean toward Microsoft Azure, Indian hospitals often choose the more economical DigitalOcean, while very small clinics can even operate on local Linux servers.
This adaptability ensures that healthcare providers of all sizes can adopt cloud-based patient care solutions within their budget. Adding to this, the iTouch platform helps device makers cut product development costs by providing ready-to-use cloud infrastructure on a software-as-a-service (SaaS) model. This not only makes connected solutions more affordable but also accelerates time-to-market for original equipment manufacturers (OEMs).
Q. Can you explain how you manage the engineering and component side of this process?
A. Many of the solutions we work on involve advanced, niche technologies that must be converted into tangible products. This involves PCB design, component selection, and prototyping with state-of-the-art sensors and electronics. For sourcing, we often rely on global distributors such as DigiKey and Mouser since some of the advanced components are not readily available in India. That said, we are actively exploring local sourcing options for specialised components. Once components are selected, we collaborate with electronic manufacturing services (EMS) vendors for board assembly. We thoroughly test them against performance and reliability parameters, and only then integrate them into the final product.
Q. What kind of engineering team powers your work?
A. Our team is highly technical, with about 90% being engineers. We have specialised departments for hardware, firmware, software, testing, validation, and regulatory affairs. Each is critical for building safe, compliant medical devices. Most of our work cannot be outsourced, so we rely on permanent employees with deep domain expertise. Currently, we are about 100 employees, spread across three Indian offices in Bengaluru, Pune, and Thiruvananthapuram. We also maintain global offices in the Netherlands and the US. Around 95% of our workforce is based in India.
Q. How do you manage project timelines, given the regulatory and technical hurdles?
A. Customers always ask about cost and deadlines. Typically, MedTech development takes two to three years, but we aim to deliver within 12 months, from concept and prototype to regulatory approval. That speed is our differentiator. We achieve this because we do everything in-house, including hardware, firmware, cloud, and industrial design, so there are no long handovers between different partners. We also embed regulatory considerations right from the design stage, preventing costly redesigns later.
Q. How do you ensure data privacy compliance?
A. Unlike generic Internet of Things (IoT), our Internet of Medical Things (IoMT) platform is built from the ground up with compliance in mind. We designed it to segregate private and medical data according to Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) standards. Any hospital or client adopting iTouch automatically inherits compliance, which gives them confidence in both security and legality.
Q. How do you ensure patient data security?
A. Cybersecurity is non-negotiable in healthcare. One of our platforms even achieved FDA certification, which required rigorous third-party testing and validation. Our approach is 360-degree cybersecurity. It starts with threat modelling and risk management, followed by embedding security into design, development, and testing. Post-release, we have systems for identifying new threats, addressing vulnerabilities, and releasing patches. We also subject our products to independent third-party penetration testing before deployment.
Q. Who are your main customers?
A. We cater to three groups: MedTech product companies of all sizes needing R&D support, hospitals using our iTouch cloud platform for digital health integration, and startups seeking a partner to turn healthcare ideas into market-ready products.
Q. How do you tackle interoperability issues?
A. That is exactly the problem our platform solves. In hospitals today, a GE monitor might only talk to a GE system, while a Philips device will not integrate seamlessly. Our platform is vendor-agnostic and multi-protocol, designed to pre-integrate devices across multiple manufacturers. Hospitals can choose the vendors they want, and we ensure smooth integration into a single digital ecosystem.
Q. Integration often causes deployment delays. Have you faced such issues?
A. Integration is a journey. We have pre-integrated many devices, so deployments are faster. Occasionally, when hospitals buy a new vendor product, sometimes with closed protocols, we face delays. But once we integrate it at one hospital, it becomes a pre-built module for all others. So, over time, the process keeps getting smoother.
Q. What happens in regions with unstable internet?
A. Connectivity is a real challenge. That is why our hub is designed to handle multi-mode connectivity and data caching. If the internet drops, data is stored locally and automatically uploaded once the connection is restored. We also support offline and private-cloud deployments for hospitals that want backup or want to host everything within their firewall. This flexibility ensures patient care is not compromised, even in low-connectivity areas.
Q. Given regulatory complexities across regions, have you faced product launch delays?
A. Regulatory approvals are always challenging. In our case, one product cleared FDA certification in just five months, slightly delayed, but still much faster than industry averages. Our proactive approach, working closely with regulators, designing with compliance in mind, and maintaining high-quality documentation, has helped minimise delays. While projects occasionally face delays due to client-side changes or added features, about 80 to 90% of our projects are delivered on time, which is considered very strong in this industry. More importantly, every project we have started has been completed and successfully certified.
Q. Are you actively working with vendors or partners to scale?
A. The MedTech industry is very partner-driven, and strategic collaborations are central to our growth. For example, in Europe, we work with firms such as Q-Tech that specialise in regulatory consulting. We support their clients in product development, and in return, we rely on them for regulatory support in European markets. Similarly, in the cloud space, particularly hospital-based platforms, we have partnerships for device integration and pre-integration into our solutions. These alliances ensure that we can deliver comprehensive, end-to-end solutions to clients across the ecosystem.
Q. How do OEM partnerships support your growth?
A. We have built strong partnerships with equipment vendors and OEMs whose devices we can seamlessly integrate into our cloud platform. This interoperability is a major differentiator. As for growth, we are scaling aggressively in the coming years, but entirely through organic expansion. We are not venture-capital backed, nor do we plan to be. Our focus is on identifying strategic areas of growth and expanding sustainably.
Q. Where does your development work happen, and how do you approach global expansion?
A. Most of our development takes place in India, but whenever a client project requires local presence, we evaluate setting up teams in that region. Currently, we are active in three countries, and expansion, both within India and globally, is very much on the roadmap. Our growth is client-driven: as opportunities arise, we establish local presence while ensuring our current structure remains efficient. With its end-to-end MedTech development model, iLogix bridges electronics, software, and compliance, embedding regulatory design early, sourcing advanced components, and delivering within compressed timelines to help clients accelerate innovation and bring cutting-edge medical technologies to patients faster.
Q. How has the company performed in recent years, and what is your revenue outlook?
A. The last two years have seen modest growth, especially in the post-COVID environment. We have been focused on completing ongoing projects and consolidating our niche positioning rather than chasing aggressive scale. Our sweet spot lies in projects where we can combine electronics, firmware, design, and cloud connectivity, particularly in areas such as electrical stimulation devices, ECG, electromyography (EMG), and connected diagnostic solutions.
We are not into designing very large machines such as X-ray or magnetic resonance imaging (MRI) systems. Instead, we focus on devices that demand intricate, high-value technology in a manageable form factor. This approach has helped us stay selective and build strong credibility. Looking ahead, the next two years will be about scaling aggressively. We have spent a decade building 360-degree capabilities across design, hardware, firmware, software, cloud, and regulatory compliance. Now, with partnerships and global clients in place, the stage is set for growth.
Q. How do you manage revenue and payment structures across geographies?
A. All payments are routed through our India entity, but what really defines us is our outcome-driven model. About 99% of projects follow a milestone-based structure, where clients pay only when tangible outputs are delivered, typically monthly or quarterly, rather than for hours spent. We begin with a small kickoff fee to ensure commitment, then align payments to engineering milestones. This approach builds trust, accountability, and ensures clients see clear value at every stage.
Q. What about intellectual property, does iOrbit hold patents?
A. We do have patents in the data domain. But since much of our work is product development for clients, we do not always pursue patents ourselves. Our focus is more on delivering end-to-end innovation for customers rather than building a large patent portfolio.
Q. How do you see the company evolving in the next phase of growth?
A. The foundation has been laid, with our clients spanning the US, Europe, Singapore, and India. We have built strong regulatory and clinical partnerships, and we have proven our end-to-end capabilities. Now, the focus is on scaling, branding, and deeper penetration in global markets. We have launched a rebranding initiative, refreshed our website, and strengthened our partnerships with organisations such as Pure Clinical, MDR Data, and Qutex Group. With these steps, we are well-positioned to achieve significant scale in the next two years.
Q. Where do you see the company’s business model evolving?
A. Right now, most of our revenues are project-based. But in the next five years, our SaaS revenues from cloud-based platforms will become the major growth driver. The iTouch platform is central to this strategy, as it allows device makers and hospitals to go digital at a fraction of the cost, while giving us recurring revenue streams. It is clear that iOrbit is not just building connected medical devices but also shaping the future of affordable, compliant, and interoperable healthcare technology.
Q. How would you describe the company’s long-term mission?
A. Our mission is to be the trusted MedTech development partner globally, bringing together electronics, software, AI, and cloud to build safer, smarter healthcare solutions. We want to empower both established players and emerging startups to bring innovative healthcare products to market faster and with full compliance.
