Healthcare & TechnologyDelivery Management in Medical and Healthcare Software Development

Author: Diana Oprean | SMEDIX Delivery Manager

During the past couple of years, medical and healthcare software development has been growing due to the digital transformation of the healthcare industry. The growing trend of digitalization in healthcare is driven by consumer demand for efficient and advanced treatment solutions.

The overall spending on healthcare is expected to grow by the year 2023, according to Deloitte. And after the lockdown experience, the demand for healthcare software development solutions has also increased. The COVID-19 healthcare IT market impact consists of an increase of 16.7% market growth between 2019 and 2020.

We are now able to integrate big data, IoT, artificial intelligence and machine learning algorithms into our medical software development, which is furthermore fueling the market growth.

Does Agile work for medical software development?

There is no short answer to this question. Taking an iterative, incremental lean approach to streamline the delivery of projects applies in medical and healthcare software projects, as well. Most of the projects I helped deliver here at SMEDIX have used the benefits of Agile methodologies. 

The delivery frameworks we used the most are:

1.Basic Agile model for small- to medium-sized projects. 

We mostly used the Scrum methodology, but Kanban may also apply for certain type of projects.

2.We took advantage of full-scale SAFe processes for enterprise projects that have multiple teams working on a common backlog.

Specific milestones for medical software development

Some of the particularities of the medical software projects, if they impact the patient’s wellbeing, are getting the software approved by a regulatory body. There are several international regulatory bodies: for instance, in the U.S., the software must pass FDA (U.S. Food and Drug Administration) approval, while for Europe, it must pass the EMA (The European Medicines Agency). In preparation for submitting the software to receive these approvals, a great deal of documentation must be provided for all the SDLC (software development life cycle) phases of the project. We are affecting patient’s lives; therefore, the verification and validation efforts are crucial and need to be traceable. 

Here are some of the most common milestones found in medical software development:

Identify the software requirements. 

• Clinical and user information is used to create proper requirements for the software.

Research and propose a medical software solution. 

• Data collection, feasibility reports and prototyping are parts of this phase.

Design and development of the software.

• In this stage we develop, test, and document the solution. One of the specific characteristics we must pay attention to is the usage of 3rd party software (Off-the-shelf software) as they may compromise device safety and pre-market approval by regulatory agencies.

Software verification and testing. 

• In addition to the testing done during the development phase, this milestone ensures that the software is built is according to the requirements and does not have any deviations or bugs.

Software deployment and validation. 

• Deploy and deliver the medical software solution.

FDA/EMA approval

• If we are developing software for a medical device, this is a mandatory phase before the software can be used in the field.

People growth in medical software development

Developing features and fixing bugs for a medical software project may directly affect a patient’s life. For most of the team members, this is a very motivating factor. Contributing to a piece of software that improves someone’s life is one of the greatest intrinsic motivators I have discovered while working in software development.

Developing software for medical instruments may require the development teams to support older technologies as the hardware is not always as easy to upgrade. This might be seen as a demotivator in some cases, but in other cases, the development teams might encounter some challenges that allow them to grow in different areas such as: implementing performant algorithms, different communication protocols, direct interactions with the OS. 

Conclusion

The medical and healthcare software development as a vertical of software development is going to continue growing in the following years. While there are a lot of similarities with basic software development, we must be aware of the specific milestones needed for medical software projects so that we can deliver on time. The tech stack may vary a lot from older to state-of-the-art technologies so a delivery manager must be prepared for these types of challenges when staffing the projects.

References

https://www.scrum.org/

https://www.scaledagileframework.com/

https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/global-health-care-sector-outlook.html

https://www.fda.gov/

https://www.ema.europa.eu/en