Enterprises and startups have acknowledged the significance of custom medical software development and have intensified their investments in this area to cater to evolving healthcare needs.
Both the public and private sectors in Europe and the US have expedited the implementation of new digital healthcare initiatives. Notably, venture capital investment in digital health has experienced a substantial growth of 66%, rising from $8+ billion in 2019 to $14+ billion in 2020.
Considering the increasing influence of digital technologies in everyday life and the disruptive impact of COVID-19 on lifestyles, healthcare providers are leveraging digital platforms not only to enhance their workflows but also to meet the demands of consumers and patients regarding their care and well-being.
Therefore, we present you with a comprehensive guide to custom medical software development in 2023, taking into account the prevailing trends and challenges within the healthcare industry today.
The concept of medical software
When software is used to diagnose, monitor, prevent, predict, treat, or alleviate disease or other pathological conditions, it may be considered part of a medical device or a medical device in its own right. Also, software designed for fitness and wellness purposes is not considered a medical product.
There are several international IMDRF (Medical Device Regulators Forum) recommendations for medical software. Compliance with these recommendations greatly facilitates the registration process for medical software, as Digicode explains.
MDRC and the worldwide requirements for custom medical software development
In the European Union, medical software, whether it is part of a medical device or a stand-alone medical product, may be subject to two EU Regulations depending on its purpose and functionality. In both cases, when developing and launching products on the market, it is necessary to take into account the requirements of the EU Guidelines for the information security of medical devices MDCG 2019-16.
The FDA identifies three types of software: software that is part of a medical device (Software in a Medical Device), software that is itself a separate medical product (SaMD – Software as a Medical Device), and software used to manufacture medical devices.
Each of these three options has its requirements set out in the relevant parts of the US Code of Federal Regulations. If your target market is the US, following the IMDRF guidelines can greatly speed up the registration process.
MDRC helps manufacturers of medical devices, medical devices, and other medical devices to register and launch products in the markets of the European Union, the United States, and Latin America, regardless of the complexity of the products. Software, both as part of medical devices and as stand-alone products for medical use, may require simple regulatory notification procedures.
Gadgets for medical applications
Gadgets used for medical purposes may be considered medical devices by a country’s regulatory authorities. In some cases, a medical device is not the entire gadget, but rather its parts – most commonly software. To understand whether an entire product is subject to medical product regulatory requirements or only parts of it, it is necessary to determine whether the entire product is intended for medical purposes or only parts of it.
For example, a smartphone on which an application is installed to diagnose, monitor, prevent, predict, treat, or alleviate disease or other pathological conditions is not itself a medical product because the intended use of the smartphone is not medical.
And an application installed on a smartphone constitutes a medical product because it meets the criteria defining medical products in most countries. Often, determining whether a gadget and its components belong to the category of medical devices and determining the risk class of a product can be quite a complicated process.
In turn, conducting this process correctly will ensure faster product registration and avoid unnecessary financial losses.
Depending on their purpose and functionality, gadgets for medical applications or parts thereof fall under Regulation 2017/745 (medical devices) or EU Regulation 2017/746 (in vitro diagnostic products).
The regulatory requirements in the EU for gadgets or parts thereof and the product classification principles that apply to them correspond to the requirements and principles that apply to conventional medical devices or in vitro diagnostic products.
In the US, gadgets for medical use are subject to portions of the Code of Federal Regulations that apply to medical products.
The functionality of medical software required by every clinic
In clusters of medical centers that require mandatory automation and modernization, the following functionalities are crucial:
1 – Reporting. The medical software should have the capability to generate various reports, including financial and statistical documents, as well as reports related to laboratory tests.
2 – Information integration. The software should seamlessly integrate with online cash registers, federal systems, and other relevant services to ensure efficient information exchange.
3 – Payment for medical services. The software should be able to interact with different funding channels. For instance, it should handle both paid and free services, maintaining personalized records for each channel.
4 – Information database maintenance. The program should include templates for standard documents such as consent forms for personal data processing and contracts for medical services. This ensures proper documentation and compliance.
5 – Specialist management. All information entered by doctors into the system should be saved in electronic format and automatically considered when generating invoices or handling billing processes.
6 – Online patient registration. The software should provide an interactive grid with a schedule of doctor’s appointments, enabling patients to conveniently register online.
By considering these functionalities, clinics can make informed decisions when selecting medical software. Be sure, Digicode can develop software that will align with your specific requirements to enhance the overall operations.
Custom medical software development has become increasingly significant in meeting evolving healthcare needs. Both public and private sectors in Europe and the US have accelerated digital healthcare initiatives with substantial growth in venture capital investment in digital health.
Digital platforms are leveraged by healthcare providers to improve workflows and meet patient demands. Compliance with international recommendations greatly facilitates the registration process for medical software.
The EU, the US, Mercosur bloc countries, and Mexico have specific regulations that need to be followed. Determining whether a gadget and its components belong to the category of medical devices and determining the risk class of a product can be complicated.