Challenges and opportunities for MedTech software development experts

The MedTech industry continuously pushes the boundaries of innovation to improve patient care. Patients can receive better treatment and diagnosis with new devices and software development. However, implementing these new technologies can pose challenges in complying with safety regulations and meeting industry standards. 

We’ve talked to our expert Embedded Software Research engineer, Patryk Monarcha, to get an additional insiders perspective on what helps deliver a successful medtech innovation.

The importance of medical understanding in developing software for healthcare applications

One key to navigating these challenges is working closely with medical professionals, including doctors and specialists.As our Embedded Software Researcher, Patryk Monarcha, explains: “It is essential to know what you are programming – you must have some medical knowledge. For example, if our team analyzes a heart signal, we definitely should know how the signal should look, how the heart works, why everything goes down on the graph etc.”

qrs complex with irregularities

For example, a common external disturbance to a software developer could be a significant characteristic point on the graph, indicating the presence of some disease to a doctor. We must consider this significant difference to ensure the device serves its purpose, as it may directly impact the patient’s safety and well-being.

Therefore, having ongoing medical contact, preferably with a facility or doctor for whom the project is being created, can help ensure that the product meets the needs of medical professionals and many patients.

“Effective communication with the client’s team is an ongoing and continuous process in our work, especially when we aim to develop the devices for the next generation of medicine. This is crucial as our team strives to meet medical standards and ensure that our technology aligns with the needs of clinicians and patients.” – our Senior Engineer emphasises.

PM - Developer - Doctor mutual communication diagram

Meeting medical devices regulatory standards

The healthcare industry is a highly regulated sector, and organizations must adhere to numerous laws and regulations. Among these, the following statutes are some of the most significant:

Regulatory and compliance considerations

Regulatory and compliance logos - FDA 21 CFR 820, ISO 13485:216, EU-MRD 2017/745, Medical Class 1 Device, ISPE GAMP

In addition to manufacturers, importers and distributors of medical devices in the EU, the new regulations are also relevant for compliance or quality management professionals for example.

The General Data Protection Regulation (GDPR)

The General Data Protection Regulation GDPR recognizes the unique nature of health data and has taken steps to provide comprehensive protection for this type of information. For example, the regulations governing clinical trials and mobile medical technologies are subject to strict data protection rules to ensure that patients’ privacy rights are respected while fostering innovation and advancing the field of medicine.

Map of Europe where Regulation (EU) 2017/745 applies

Health Insurance Portability and Accountability Act (HIPAA)

HIPAA is the federal Health Insurance Portability and Accountability Act of 1996, initially passed to protect healthcare for workers transitioning between jobs. Today, HIPAA is most commonly associated with safeguarding the privacy and security of confidential patient information. The legislation outlines how medical professionals can store, use, and share patient information and imposes civil and criminal penalties for violations.

The HITECH Act

The HITECH Act mandates regular audits of healthcare providers to ensure they comply with HIPAA privacy and security requirements. The HITECH Act sets high standards for information security, and MedTech providers and associated businesses may face financial penalties if they fail to protect patient information. The primary regulation governing medical devices in the European Union is Regulation (EU) 2017/745, which you can find at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32017R0745.

The Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) is a recently implemented regulation that manages the production and distribution of medical devices. As of May 26th, 2021, all medical device manufacturers who wish to market their products in the EU must comply with this regulation. According to the EU MDR, software designed for medical purposes is considered a medical device.

Food and Drug Administration (FDA)

In the U.S., medical device products are subject to regulation by the FDA, which monitors the safety of all regulated medical products.

Complying with safety regulations is essential in the MedTech industry, and every device must meet the necessary standards to ensure the safety of the users. This process is lengthy and costly, requiring significant financial investment from the client.

US FDA medical device approvals chart

(Table source: Pulse of the industry medical technology report 2022, EY.)

ISO 13485

Apart from the mandatory regulations, there are also compliance certifications medical products can acquire, to confirm their compliance and reliability. An example of such a certificate is ISO 13485, which attests to the device’s compliance with regulatory requirements.
Although acquiring a compliance certification isn’t mandatory, it might make an excellent selling point. The product gains necessary credibility and helps save time in proving that it meets all the required standards, so it’s a welcome asset to consider in every MedTech project.

On average, a medical project takes between 3 to 5 years to complete.

Due to the complexity of medical devices on the regulatory level, building a team with that in mind is always good. Someone who can understand legal nuances can be invaluable during the entire development process, as they can set the rest of the team on the right course to meet the necessary regulation in both the early and later stages of the project.

5-step process to develop a medical device - 1 discovery and risk analysis, 2 concept and feasibility, 3 design and development, 4 final validation and launch, 5 production and market introduction

“Our software is developed to meet the highest standards and be approved by regulatory bodies to guarantee its safety and effectiveness. Before it goes live, it is thoroughly tested by medical professionals to ensure that it meets the requirements and ultimately achieves the goal of early detection and improved patient outcomes.”- says Patryk Monarcha.

Ensuring the quality of clinical trials is an essential aspect of developing life-saving treatments. Implementing real-time tracking and reporting mechanisms can help reduce the risk of faulty incidents and facilitate timely improvements.

A look into the future of medical innovation

The future of the MedTech industry is looking brighter than ever, with great freedom for innovation and new measurement methods that will revolutionize patient care.
Patryk Monarcha highlights the need for the MedTech industry to embrace innovative tools: “instead of relying on old, clunky equipment, we can propose better tools for patients, like using smartwatches for simple heart readings.”

“As we move forward, machine learning, artificial intelligence and data analysis will continue to support the advancement of medical expertise and the development of more effective treatments,” says Embedded Engineer Michał Gorgon. “And who knows, maybe one day, robots will even replace doctors, allowing them even more accurate diagnoses and treatment options. The possibilities for the future of MedTech are endless.”

A look into the future of medical innovation

In the MedTech world, innovation is the leading focus as we strive to treat patients with better tools and advanced science. Working closely with medical professionals is essential to developing solutions that meet the needs of patients and ensure their safety. In today’s world, cutting-edge technology has opened up new possibilities for researchers to create products that can save lives in many cases. The key to success in this field is prioritizing the products’ quality and their impact on patients.

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