Challenges & Keys to Success in Digital Health Tech Development

Over the last 10 years, market disruptors and technological innovations have radically transformed the way we live and work – and healthcare is no exception. The rapid pace of digitalization in the spheres of digital health and medical devices has the potential to completely transform patient experiences and the relationship between patients and providers.

Since the onset of the COVID-19 pandemic, consumer behaviors and expectations when it comes to digital healthcare have skyrocketed. They have much higher standards when it comes to flexibility, convenience, access, and personalization. With the line between consumer and medical-grade devices becoming more and more blurry, manufacturers are well-positioned to take advantage of this market shift by creating innovative solutions for healthcare providers and patients, revolutionizing their business operations and company culture in the process. 

What exactly is digital health? 

Digital health refers to the intersection between technology and healthcare. It is a broad and multi-disciplinary field that aims to improve experiences, the precision of care, and overall health outcomes. It does this by leveraging the ever-growing power of computer software, Internet of Things (IoT), augmented reality (AR), blockchain, and more. 

Stakeholders in digital healthcare include: 

• Patients 
• Healthcare practitioners 
• Researchers 
• Software developers 
• Medical device manufacturers 

The idea behind digital health innovations is generally to boost accuracy and efficiency while saving time and providing the best care possible. For context, let’s take a look at some examples of digital health technology that are already in use: 

• Mobile health (mHealth): The use of mobile and wireless technology to support health objectives. For example, Remote Patient Monitoring uses medical devices to capture patient data in one location and transmit it to healthcare providers in another for them to review and make decisions. 

• Electronic health records (EHRs): EHRs are digital records of health information that enable a patient’s data to move with them wherever they go. These can be shared with other healthcare providers or labs for example. 

• Digital twins: These are virtual models that leverage AI, machine learning, and real-time data from wearable devices and patient records. In the context of digital health, these models can be useful for diagnosing and treating patients, as well as improving health as a whole. They can be used to show how devices would function under different conditions. 

• Wearable devices: These are devices like smartwatches or implants that are worn by the user and provide health-tracking services like heart rate measurement, calorie counting, and sleep monitoring due to being in contact with the wearer’s body. Nowadays, some wearable devices can even manage electrocardiography, glucose monitoring, and pulse oximeters. 

• Telehealth: It refers to applications of communications technologies by doctors to provide care to patients without an in-person office visit. Some innovative examples of telehealth include virtual doctor visits, sensors that alert caregivers if a patient with dementia leaves their house, and surgeons using robotic technology to carry out procedures from a different location than their patients. 

What are the challenges in digital health tech development? 

Technological innovations over the last 10 years have opened a myriad of doors when it comes to the potential of digital health technology. However, in this highly regulated and safety-critical field, there are certain challenges that come along with this digital transformation. 

Regulatory compliance

Achieving regulatory compliance in the field of digital health and medical devices is a complex endeavor. Manufacturers are under considerable pressure to ensure that their existing business operations, quality management systems, and software development efforts can measure up to ever-changing and increasing standards. 

For example, until 2021 medical device development in the European market was regulated by the Medical Devices Directive. Originally introduced in 1992, this directive was designed to align laws relating to medical device production in the EU. However, with the MDD, each country within the European Union was able to create its own laws to carry out the guidance in the document, creating problematic inconsistencies that some companies took advantage of and resulting in subpar products entering the market. This is one of the reasons the EU introduced the EU MDR, or the European Union Medical Device Regulation, a much stricter and more rigorous standard that developers now need to adhere to. 

Privacy and security concerns

Cyberattacks and data breaches in digital healthcare are rising. While traditional embedded devices could be completely isolated from the rest of the healthcare ecosystem, new digital health technology prioritizes data accessibility and mobility and is highly connected to the rest of the healthcare ecosystem as a result. 

This huge, often vulnerable amount of personal and sensitive data is a tantalizing prospect for hackers. 2023 was the worst-ever year for breached healthcare records with breached records that affected more than 133 million records, a 156% increase from 2022. Since the onset of the pandemic, healthcare facilities, hospitals, and research centers have been targeted by malicious cybersecurity attacks more than ever before, making data breaches a huge concern for digital healthcare providers who want to provide the best possible experience for patients and also avoid non-compliance fines. 

Data quality

New software like Electronic Health Records and mHealth has made it easier for providers to access medical data and histories, generate price patient overviews, and seamlessly transfer patient data. However, not all organizations are prepared to continuously manage and monitor data quality. Without data integrity, this seamless data transfer, accurate analytics, and even compliance journeys can become extremely challenging. To address these issues, many organizations are investing heavily in API solutions and data interoperability over the next three to five years. 

What are the keys to success in digital health tech development? 

Consumers nowadays are taking charge of managing their own health and expect improved access to healthcare across the board. In order to meet evolving customer expectations, digital health technology providers should consider the following keys to success: 

Finding (and keeping) the right talent 

Digital transformation initiatives in the health and medical device fields require the right quality and quantity of talent. 47% of respondents in a Deloitte survey stated that workforce staffing challenges and shortages were the second biggest barriers hindering the organization’s ability to reach an ideal digital state. The same survey stated that there was a consensus among interviewees on the need to not only hire more skilled talent but also to reskill and upskill their existing workforce to use digital tools effectively. 

Getting management buy-in 

Having an executive champion and the right organizational leadership is essential for the success of digital transformation initiatives in digital health companies. They accelerate digital transformation efforts by providing the right resources, talent, and empowerment to make key decisions. This helps software development teams speed up product development cycles, while the executive champion works on changing the organizational culture and focuses on change management throughout the process. An effective executive champion helps build a digital company that emphasizes excellent communication, collaboration, and transparency across all levels of the organization. 

Incorporate risk management from the start 

The more digital healthcare and medical devices become, the more risk they open themselves up to, in what is already a safety-critical industry very wary of risk. Regulations and standards are becoming increasingly complex to mirror the increased level of risk - in turn, this makes compliance efforts challenging. Incorporating risk management from the start of product inception and using application lifecycle management can significantly help when it comes to mitigating risks, rather than doing it in a piecemeal fashion through product development.