As the healthcare ecosystem rapidly shifts towards value-based care, the need for innovative and data driven software is being felt more than ever. Teams developing healthcare software have traditionally followed the waterfall model of software development.
With linear step-wise approach which consists of fixed sequential procedures and upfront planning that requires all the requirements and expectations to be laid out before the project commences, the waterfall model is fairly restrictive.
Agile software development on the other hand offers a chance for incremental development which mitigates risks, fosters innovation and enables faster time to market for the software products developed. By eliminating the top-down approach of waterfall development, following Agile methodology for healthcare software development has proven benefits.
The highly regulated environment in healthcare software development and the need to meet the numerous compliance requirements were initially thought to be challenges for adoption of Agile methodologies in the healthcare niche.
However, FDA’s endorsement of Agile for healthcare software development proves that it can effectively be used to develop compliant healthcare software.
Core Elements of Agile Methodology in Healthcare
1. Sprint Planning
A sprint is a short, time-boxed period when a scrum team works to complete a set amount of work and focuses on delivering a set amount of features. One sprint usually runs between two to four weeks.
Prior to the execution of the sprint, the entire team gets together and commits to a set of user stories to be worked upon in that particular sprint. This is called as sprint planning.
2. Sprint Demonstration
At the end of every sprint, the scrum team holds a demonstration of the work accomplished in it. The product owner provides the feedback on the development completed, which ensures that the product is scalable and matches the current requirements.
3. Sprint Retrospectives
Retrospective are meetings to identify what went well during each sprint and what can be improved upon further. This results in a cyclic review and feedback that facilitates improvement in the process in real time.
Sprint retrospectives also give the scum team a chance to track the Agile metrics and get a comprehensive view of the progress the team is making.
These are short, status check meetings within the scrum team, held everyday at a predefined time to bring everyone up to date on the information that is vital for coordination. The team gets to know the current status of the team members working on the scrum tasks and can brainstorm together to overcome any roadblocks that may have come up.
User stories are defined as a set of requirements and acceptance criteria that define a feature or scenario from a user’s perspective. The backlog gives the scrum team an insight into the list of prioritized user stories.
The product owner defines which user stories need to be prioritized and included in the backlog based on product vision and business requirements.
How is Agile Software Development Implemented in Healthcare?
Healthcare is heavily regulated by a variety of government and non-governmental organizations. Even though these rules are in place to ensure patient safety, they have the unintended consequence of complicating the process of designing and building software.
Just like with Waterfall, you will need to adhere to numerous regulatory standards (such as HIPAA compliance) when delivering a healthcare application utilizing Agile. There are many advantages to employing an agile development technique, such as fostering innovation and delivering functionality more quickly. A medical device classification will necessitate stringent regulatory restrictions for the software product.
It is not common for an Agile approach to begin development sprints without first identifying all of the regulatory requirements that you must adhere to, becoming educated on them, and then developing an approach and a set of processes that will meet those requirements something that is not typical with an Agile approach.
When employing the agile process, requirements are typically defined as the project progresses. Identifying the methods needed to meet regulatory standards begins with an awareness of the unique jurisdiction where the application will run. Consult with a regulatory specialist, or if your organization already has a set of processes in place to satisfy the legal standards, use those.
Whether you create software using an Agile or Waterfall approach, the regulatory obligations will remain the same. Regulatory needs can be specified as non-functional user stories and added to the queue once they have been determined. This makes the needs access to the team and allows them to be treated the same as functional user stories in the queue.
To ensure that the team adheres to rules and can detect any potential safety issues with the product being built, usability testing, also known as formative testing, can be implemented into sprint cycles.
Benefits of Agile Methodology for Healthcare Software Development
1. Faster development timelines
The healthtech market is transforming at a rapid pace. While arenas for opportunities and innovations are coming up quickly, so are the competitors. Agile reduces the time to market the software product, allowing for faster development timelines and accelerated delivery of medical software into the market.
2. Improved development quality
There existed a significant communication gap between the business team, the developers and the quality assurance teams which prevented the communication of feedback and impacted the overall development quality. Agile, on the other hand, embeds testing and validation as an integral part of the process.
A test-driven development approach ensures that the product built meets the specified user needs, integrates with other components, and functions as intended.
3. Agility due to iterative development
With agile, healthcare software is developed iteratively. This means that instead of developing one large set of requirements, smaller, frequent releases with fewer requirements assigned to each are used. The development plan is divided into small cycles called iterations.
Scrum comprises sprints which make use of week- or two-week-long cycles. The team has to execute a usable version of the product after each sprint. The product owner reviews the product developed at the end of each sprint to receive regular feedback, validate a working product, and request changes if necessary.
4. Improved collaboration between various stakeholders
Agile takes a collaborative approach towards healthcare software development. Multiple stakeholders such as doctors, patients, medical administrators, all need to give their input to the software developers.
Each of these stakeholders may have different perspectives and market goals for the final product developed.
All Agile teams have a product owner who not only reviews the product through the planning and development stages but also views the development from the business perspective.
Regular check-ins with the stakeholders ensures that the functionalities being developed match the business user expectations and facilitate better collaboration.
5. Flexibility in project’s scope
In waterfall development, the project scope remains fixed and any changes in it require more team members to be added or timelines to be extended. Both these add to the overall development costs. In case of Agile development, the project scope remains flexible but the team is fixed.
After every sprint release, feedback on the existing features and possible improvisations is received and Agile gives you the flexibility to incorporate it. It also makes it easier for the team to adapt to market changes, changing user requirements, and budgetary changes.
All this results in development of a product that better meets the user specifications and adapts well to the current market scenario.
6. Compliance with regulatory requirements
Medical software development requires regulatory compliance to laws such as HIPAA and HITECH. Agile can deliver the necessary process control, traceability, and documentation which is a huge advantage for ensuring compliance with regulatory requirements.
Developers can incorporate compliance requirements into specific user stories and non-functional requirements, making them visible to the team.
Usability testing can also be incorporated into the sprints to ensure that the team meets the regulations laid down and is able to identify any possible safety risks with the product being developed.
Partnering with development teams who specialize in healthcare software development and follow Agile methodology in their projects can give you an upper hand as they are already well versed in the regulatory requirements needed in the healthcare domain.
7. Improved risk management for healthcare data
Security and privacy need to be baked into the fundamentals of healthcare software development. Since medical software is involved in collection, transmission and storage of protected health information (PHI) the potential risks need to be mitigated effectively.
While healthcare projects traditionally involve listing out the associated risks upfront, unforeseen risks are liable to arise at any stage. Agile development plays an important role in mitigating these risks.
Iterative development cycles in Agile ensure that both foreseen and unforeseen risks are handled effectively by the development teams. Since each sprint is of short duration, the risks are minimized and better managed.
Problems with the Agile Methodology in Healthcare
Although agile seems to be the way to go for the healthcare industry, and several surveys show that healthcare organizations recognize the need for adopting agile practices, several obstacles come in the way of the process being properly implemented.
For starters, the biggest obstacle in adopting the agile methodology is an inability to utilize its core practices and principles. Most healthcare organizations, particularly their development teams, are using the correct terminology for agile development, but don’t employ the methodology behind it.
Secondly, most organizations are trying to implement a hybrid approach, where they continue using the waterfall method and transition to agile in the middle.
One such example of this is the development of Healthcare.gov, a government-funded project aimed at helping patients choose affordable healthcare plans.
The project was executed using a waterfall method, but what the developers didn’t take into account is the expected influx of users. When the website was launched, it had five times the number of users that were expected, and it crashed within two hours.
Although the development team tried to implement both waterfall and agile methodology in the process, it failed to follow through with the core principles, which involved teamwork and releasing components one by one, gauging user feedback and interaction on them.
Last but not least, another challenge that agile software development teams face while working in the healthcare sector is with navigating the laws and regulations that are involved. Regulatory compliance is a major issue when it comes to the healthcare industry, and teams have to ensure that the final product is safe and performs well.
How Agile Software Development in Healthcare is Different from Other Industries
Each industry has its own set of fundamentals and requirements, particularly when it comes to designing and creating software. Moreover, it can be difficult to predict how the end-user will respond or interact with the software, which makes it all the more challenging to predict user expectations. Thanks to increased awareness about software, user expectations have also evolved in the past decade, particularly in the healthcare sector.
Therefore, agile development presents a viable solution in the healthcare industry, since it provides an environment in which various solutions and ideas can be tested before development is completed. It involves the creation of a functional piece of software that can be tested from the beginning of the project.
In other industries, you have the liberty to market or pitch your unfinished but working solution or product, gather feedback, and use it to optimize and finish the product. However, the healthcare industry doesn’t work this way. In this paradigm, you can’t expect to release an unfinished or untested solution and expect to receive feedback on it. Since the industry deals with human health, it doesn’t leave any room for errors or trials.
Therefore, agile software development in healthcare is much more sensitive and has to come up with a working and tested solution that works the way it is expected to. Not only does it have to work perfectly, but also complies with the applicable regulations and includes critical security protocols.
That doesn’t mean that there aren’t any improvements or upgrades to the released product, but if it starts to fail at what it is designed to do, not only will it be taken off the market, but it will also damage the organization’s credibility.
The essence of the agile methodology lies in its iterative approach, meaning that the product can be tried and tested on various stages, thus saving time that is spent in fixing the product after it is released.
Healthcare software development brings with itself unique challenges but taking the Agile approach has proven to accelerate the development timelines, keep the development costs in check while ensuring delivery of a software product that matches the market requirements.
In case you have any further questions about following Agile methodology in healthcare software development or are looking to get in touch with a team that used Agile to create, integrate and implement healthcare software solutions within your organization, get in touch with our team of expert consultants today.
With more than a decade of specialized experience in the healthcare niche, Arkenea is a trusted name in the field of medical software development. Get the partners you need to get started on developing an Agile solution and convert your idea into reality.