Guide to IoT Health Care Device Development

Health care — much like the rest of the world — is experiencing a digital revolution.

As the world of medicine shifts and evolves, people around the globe are living longer, with more complex health conditions. Consequently, health care industry professionals are seeking new technologies that enable them to improve health outcomes, reduce care costs and meet the increasing patient demand for access to their own medical information in a usable format.

Enter the Internet of Things. Health care industry innovation is happening at an extraordinary rate and at an unprecedented scale to accelerate global attainment of health and well-being. In fact, the global digital health market is expected to swell to a $158 billion valuation in 2022 as an increasing number of new health-tech devices, including fitness bands, scales, blood pressure cuffs and more, are developed.

By leveraging connectivity and technology to provide health care services, IoT health care devices maximize resources and provide increased, flexible opportunities for consumers to engage with care providers and better self-manage their physical and mental health. With health care delivery extending well beyond the walls of hospitals, it’s important to understand how the IoT is changing health care for the better, the challenges involved in IoT health care data integration and the steps that make up the IoT health care product development process. Let’s dive in!

How IoT Medical Devices Improve Health Outcomes

Applications of IoT technologies in health care range from environmental controls and security solutions to wearable sensors and cloud-connected medical equipment. Whether increasing patient comfort, facilitating improved clinician decision-making or making care environments safer for both patients and care providers, IoT health care devices are constantly evolving as technology becomes more powerful and sophisticated.

Let’s face it: Hospitals and other care facilities can be uncomfortable. IoT health care solutions provide greater comfort for patients and greater control for care providers. From smart thermostats and lighting controls to bed sensors and wearable technology, health care IoT products can make caregiving tasks and procedures easier while ensuring rooms are more tranquil and pleasant for patients.

Leveraging health care IoT gadgets for remote patient monitoring is one of the most common medical use cases. Connected devices and other wearables can automatically collect important health parameters from patients, such as heart rate, blood pressure, temperature, oxygen level and more, and send that information to a software application where care providers and/or patients can view it. In an ideal world, machine learning algorithms are used to analyze the data to recommend treatments or alert patients/caregivers to an issue. While medical IoT devices can provide continuous, automatic monitoring, thereby eliminating the need to keep records manually, it is important that these devices do not impair patient mobility.
examples of IoT health care devices
By providing timely alerts in the event of life-threatening situations, IoT in health care also helps care providers make well-informed decisions and deliver on-time treatment. Manually analyzing all of the data connected medical devices collect is a difficult, time-consuming endeavor for doctors and other health care professionals. IoT devices, on the other hand, can gather, report and analyze the data they collect in real time, delivering data-driven insights that speed the decision-making process and prevent harmful errors from being made. By facilitating real-time monitoring and alerting, IoT health care devices allow for improved accuracy of treatment plans and appropriate intervention by physicians, enhancing the results of patient care delivery.

A variety of smart sensors and systems are being used to make hospitals and health care facilities safer. Whether notifying building managers of potentially dangerous leaks or other hazards, ensuring safe storage of medications, monitoring waiting areas to notify staff when to divert critical patients elsewhere, disinfecting waiting rooms and common areas, or making massive facilities easier to navigate, using internet-connected devices in medical care settings can improve the safety of health care facilities and hospitals.

Through increased opportunities for improved safety, patient comfort, data analysis and remote assistance, health care IoT devices are driving improved health care outcomes.

The Challenges Associated With IoT in the Health Care Sector

Despite the numerous benefits they deliver, connected health care products also pose certain challenges:


Whether because of the highly sensitive nature of patient information or the imperative for medical instruments to adhere to a certain statistical accuracy, building IoT devices for the health care sector can come with myriad compliance concerns.

First, gaining Federal Drug Administration approval can be expensive because of the regulatory processes required for the development of FDA-approved health-tech devices. However, obtaining FDA clearance is not essential for consumer care gadgets. Plus, while Health Insurance Portability and Accountability Act regulations, specifically the Security Rule, examine the accessibility, integrity and confidentiality of all electronic health information, those rules do not govern Internet of Things health care devices. Even though the lack of necessary compliance minimizes some development challenges, devices still need to collect adequately accurate data to deliver user value.

Additionally, since health care is a highly regulated industry, many companies utilize a quality management system (QMS) to meet requirements and enhance satisfaction. With QMSs, however, your product development partner needs to design the product using your process while filling in all of the supporting documentation so you can get through the regulatory hurdles — and that can significantly slow development.

Patient Privacy/Data Security

Connected care devices obviously manage sensitive patient information, the value of which makes that personal health data susceptible to cybersecurity attacks. While there are no health care-specific security standards in place for IoT devices, new regulatory frameworks are being developed and deployed with increasing frequency. Check out this blog post for more information about the various privacy laws and regulations surrounding embedded security for IoT. Complicating the issue, the lacking health care IoT security standard often combines with disparate proprietary communication protocols, unclear data ownership regulations, and national and international mandates that fail to prevent data breaches to create a complex web of challenges regarding patient privacy and data security in the medical IoT space.

Data Integration and Usage

One of the most significant problems with Internet of Things in health care is the amount of effort and collaboration that would be necessary to integrate consumer health data from disparate devices into one unified view, thereby maximizing the value IoT can bring to the world of health care. Right off the bat, several different companies with varied expertise might need to partner with one another to integrate the necessary sensor technology, ensure the right path for data to travel to the cloud, and build and optimize the machine learning algorithm to analyze the consolidated data to provide the most valuable recommendations. As noted, health-tech device makers each have their own proprietary communication protocols, making information integration a significant headache for medical data dashboard manufacturers. Plus, the majority of organizations in this space justifiably believe keeping the consumer’s data in their “walled garden” is in their best interest as that approach tends to encourage customers to eventually buy add-ons.


Once IoT medical devices begin making recommendations surrounding our health and wellness, it raises concerns. If there’s a suggestion resulting in injuries, or even death, or a lack of guidance when advice should be given, problems will inevitably arise. Consequently, it’s important for IoT health care companies to understand the risk of a deficient design, manufacturing defects, product misuse or a failure to warn consumers about potential dangers related to use or misuse.

However, since the nascent health care IoT sector lacks comprehensive legal and regulatory structures to satisfactorily protect patient privacy and security, it also creates challenges for plaintiffs seeking damages. The sheer number of players often involved in the IoT health care device design and development supply chain makes it difficult to clearly allocate liability, with no understandable boundaries establishing which organization is at fault for a hack or breach.

Now that we’ve laid out the benefits and challenges, let’s dive into the IoT health care product development process.

Steps Involved in IoT Health Care Product Development


The first step in IoT health care device development is recognizing where your product fits in the market or the problem it solves. During this stage, designers and engineers research who their users are and what problems they’re encountering to understand their motivations and challenges — and how a new product can help.

During the earliest stages, it’s important to develop an initial estimate of the nonrecurring engineering (NRE) cost of a project — a rough order of magnitude (ROM) — and occasionally the bill of materials (BOM) to both point out cutting-edge design trends and advance technologies that will refine your feature set and to ensure everyone is on the same page regarding the statement of work (SoW).

Product Development

Once the idea has been generated and polished, and customers have been identified, it’s time to develop and refine the plans for the features or characteristics of a product. Most health care IoT product development companies will utilize an agile project management tool to break down and divvy up individual tasks.

These to-do’s are prioritized and executed in sprints so that all areas of development — hardware, embedded software, the mobile application and cloud interface — can progress in parallel instead of serially via sprints, the repeatable schedule blocks that make up a project’s completion process. This step entails assembling the hardware and software components according to engineering designs, models or renderings. Additionally, to ensure real-world functionality and that features are operating as expected, any necessary connections to a user interface or the cloud, security and third-party integrations are integrated during this phase.

To learn more about Cardinal Peak’s product development process, check out these blogs: ideation through SoW and project execution.

QA Testing

Ideally, each feature is tested as it is developed. When a ticket is assigned to the QA (quality assurance) team, a QA engineer tests that feature. If a feature passes, then the developer closes the ticket; but in the event the feature fails, the QA tester annotates the defect and how to recreate it, then reassigns the ticket to the developer. At the end of every sprint, QA teams should execute limited regression testing to confirm that all functionality remained intact when new features were added by the development team. By tailoring testing to target audiences when developing new IoT health care devices, product builders can improve engagement and accelerate time to market.

Read more about why Cardinal Peak builds quality testing into each step of the product development process in these QA blogs, part one and part two.

Commercialization and Continuous Support

Once the product design has been created, and the health-tech device has been developed, optimized and tested, it needs to be packaged and launched to market. Effectively introducing a health care IoT product to the public requires decisions about when and where to launch and approaches for pricing and marketing. Done right, health care IoT can unlock data to create interoperability and allow organizations to realize business value propositions.

To help ensure success in the long term, your IoT health care product design partner should either transfer the technology to your team or manage ongoing support. By building a scalable and robust solution that can be enhanced on occasion, medical IoT device makers both help ensure that systems don’t go down and conceive new ideas to improve existing solutions and add new features to them.


From enhancing patient comfort and making care environments safer for both patients and care providers to providing health care professionals with accurate, real-time and readily accessible data to make better, more informed decisions, IoT health care devices are revolutionizing the medical industry. As the world of medicine moves increasingly into the digital sphere, recognizing how connected devices are transforming health care for the better, understanding the challenges of IoT data integration and knowing how to work through the steps involved in the IoT health care product development process will only increase in importance.

Considering building a solution for IoT in health care? Now is likely a good time to get involved in this burgeoning space and your company might be the first to market with a unique, groundbreaking innovation. If you need assistance in determining how your idea could be engineered to benefit the health and wellness of the masses, overcoming the distinct challenges the health care IoT product design and development process poses, or expert guidance to bring your Internet of Things health care innovation to life, discover how Cardinal Peak can help!