Overview: New Healthcare Technologies Bring New IT and Development Challenges
The face of healthcare technology is evolving rapidly, with healthcare organizations moving to virtual platforms and mobile (mHealth) technologies to support healthcare delivery and operations. “Telemetry” is no longer confined to an inpatient unit, with Smartphone apps available that can send patient vital signs, ECGs and other information via wireless signals from home to hospital or clinic. Health records are moving towards digitalization, and the software that supports healthcare delivery has become increasingly complex.
The need for healthcare to be able to respond in a timely manner to development that supports clinical decision-making, care delivery and administration in the midst of new environments, while maintaining compliance with regulatory agencies, has become critical. Agile methodologies offer solutions to many of these industry challenges.
ICD-10 Compliance and Healthcare IT Concerns
In order to make the transition to ICD-10 mandated by October 1, 2013, healthcare organizations and providers must verify all business processes, data stores, applications and reports impacted by the change to ICD-10 diagnostic and procedure codes, and allow drill-down to the new diagnostic categories. This task will require verifying current ICD-9 codes maintained within the application logic for supporting business systems.
IT Departments are struggling to define the technical specifications that will guide in-house development and remediation, which requires a large amount of collaboration with administrative and business managers1. Scrum practices make absolute sense in this scenario, since they are designed to increase communication between ‘business” and “development” and can improve the project management and velocity for achieving this task.
One issue surrounding this transition is the use of conversions to deal with ICD-10. Jim Schiel, a cPrime Agile Instructor and Coach, states, “Numerous organizations are taking a ‘crosswalk’ approach,” They are taking the code and information they already have, and converting it over to ICD-10. The challenge is defining at the beginning of this process exactly what data an organization will need. With agile, as the conversion takes place, they can take the original definitions for data required, and refine them as they talk with the customer, to reflect the specific challenges that their organization faces for data collection – and, implement this quickly. This is much better than waiting the six months or longer that waterfall would require.”
Healthcare Business Data Mining and Agile
Data mining and the resulting health analytics and business intelligence have become an important source of information in an industry driven by evidenced-based practice, where treatment is based upon proven value. In addition, insurance providers must demonstrate improved medical loss ratios. This requires improved data sharing between healthcare researchers, providers and insurers, and the development of systems that support clinical decisions and practices within patient populations.
Agile development can help solve these challenges. It allows the rapid delivery of information, and the ability to quickly redefine what needs to be developed next in response to data received. Agile Data Warehousing and governance have become preferred methods for data development for this purpose2.
The Advantages of Agile for Medical device manufacturers
In the past, companies that develop medical devices were slow to adopt agile. “They will sometimes ask, ‘How can you deliver quality software with agile?’” says Schiel, “or even, ‘the FDA won’t possibly allow that. This has been a barrier to adoption, even though the advantages of agile are being seen.”
Companies that develop medical devices used by healthcare organizations often would like to reduce the lengthy time to market that traditional waterfall methodologies impose, and struggle to see how agile can work in an industry that must comply with FDA, IEC, HIPAA, and other regulations for data security, reliability, specification, quality and design controls.
Agile development offers significant benefits to medical device manufacturers. These include:
- The pace of overall development is improved
- The ability to incorporate user and stakeholder feedback early in the development cycle helps ensure that a successful product is built with the features that reflect current business needs. Agile allows suggestions to be added in earlier instead of later, when changes are more costly. This is a huge improvement over waterfall methods, where initial requirements analysis and then development can cause a gap of years between initial request for software, and the final delivery, creating “feature creep” in order to bring the product up to date. “In healthcare, things change quickly and the information environment is extremely complex,” says Schiel. “Healthcare providers often don’t know exactly what they need, until you start building; or, until they get hit by a circumstance they hadn’t foreseen, and realize that they need an additional feature to deal with it. Waterfall doesn’twork at all well in this type of situation, while agile allows the flexibility to make these needed changes and updates during development.”
- Development with agile is more transparent, with working features that can be demonstrated in a deployment context at the end of each sprint. Stakeholders can see visible proof of project progress, and initial testing done.
Risk management is a large, and understandable, concern, when developing devices that can impact patient outcomes. Scrum practices are designed to allow early identification of risks. To meet quality assurance and management goals, the integrated, continuous testing that is core to the agile process (causing high-quality software development as the standard) is often supplemented with specific controls and more frequent review cycles.
The key during the planning phase for agile implementation is to identify the documents required for regulatory compliance, and evidence which must be submitted. This includes evidence that the design and development of the device follow Quality System Regulations as defined in the FDA’s “The Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices3,” with formal review and approval processes in place as defined by the FDA.
In practice, agile has been implemented by numerous well-known medical device manufacturers, including Abbott Laboratories, which reported schedule and team reductions of 20%-30%, cost savings of 35% – 50%, and fewer software defects after going agile4. Metronic reported that after implementing agile practices, their development teams found that work was more enjoyable, they worked better together, found bugs earlier, and felt they achieved higher quality5.
GE Healthcare implemented agile within GE Healthcare Imaging Solutions. The results were so successful, it led Andrew Deitsch, VP and General manager for GE Healthcare IT’s Imaging Solutions, and Ross Hughes, GE Healthcare IT’s Scrum Master to state, “We feel that the benefits so far of our agile adoption are worth the effort. We’re now beginning the next phase of our transition by rolling out scrum globally to the rest of GE Healthcare6.”
Schiel sees specific advantage of agile adoption by medical device manufacturers: “They often deal with how to combine hardware development and software development, and get the two schedules to come together well,” he says. He notes that the key is to plan out the hardware approach, and then start the software development after the hardware is coming along well. He states, “The great advantage of agile is that it lets you incrementally test working software on the hardware – and know if it’s working, early on. With waterfall, you have to ‘hope’ that both will come together in the right way, but it’s really a matter of luck if you can’t test the software on the actual hardware. The bottom line: If testing isn’t done often enough, software goes out doing unexpected stuff – and agile can prevent this from happening. It can actually make the medical device arena even safer, if done correctly.”
Healthcare IT Departments: Going Agile to Reduce Time & Cost
In recent years, healthcare IT management has looked closely at whether agile can help solve some of its major challenges. These include overcoming the limitations of legacy systems, finding universal development tools, increased lifecycle transparency, and improved collaboration among distributed teams and between developers and product owners. The pressure has been on to reduce development time for business and clinical support systems, without sacrificing quality and reliability, while maintaining secure data exchange between organizations.
Another challenge faced by healthcare organizations is the initiative to adopt electronic health records. Medicare and Medicaid incentive programs have helped, with hospital adoption rates of basic EHR rising from 11.5% to 18% between 2010 and 20117. Making the transition to electronic records requires significant data entry and implementation tasks (such as developing software patches to allow EHR software with different standards to communicate with each other).
One problem that healthcare organizations face is that currently, no one is really certain yet what EHR will look like in practice. “A lot of healthcare organizations know they will need to move to electronic health records and electronic medical records,” says Schiel, “but they aren’t sure yet of all the benefits they will get from it. That’s where agile works well. Using agile, you can say, ‘Let’s start with what we know, and when we identify something more valuable, we can go there.”
This flexibility of agile is a big advantage, especially since at this time, the government regulations regarding security, privacy and how access to EHR will be maintained has yet to be fully defined. If regulations change, agile will allow development to meet these requirements much more easily than waterfall methods would.
Going Agile for Healthcare: How cPrime Helps the Transition
When a healthcare organization that is highly regulated decides to go agile, they must adapt the process to their environment. At cPrime, we address the challenges of changing organizational structure to reflect Scrum and agile teamwork.
Agile Assessment and Planning: Critical to Success
cPrime first conducts an initial assessment of the organization, its culture, and unique pain points. The goal is to adapt agile methodologies to the organization’s unique needs. We meet with management, developers, and quality and regulatory teams, in order to help them understand how agile can work with quality management systems and regulatory requirements.
The initial planning phase for the transition to agile is critical. At cPrime, we believe in implementing agile with small changes that deliver the greatest value, first. In practice, this will often mean initiating pilot projects within an organization, with the initial teams undergoing classroom training, which includes hands-on practice in using scrum and agile tools, prior to starting the first sprint.
Scrum teams are defined, as Scrum masters, Product Owners and team members are designated. This can include engineers, RA/QA, design, materials, and other departments, in a cross-functional team dedicated to developing the product together. Each member undergoes the training and mentoring necessary to successfully fulfilling their role.
cPrime team members, which includes trainers, coaches and Scrum experts are on site to ensure that the transition goes smoothly.
During planning, an agile lifecycle management (ALM) tool is selected, such as Rally, GreenHopper (JIRA) or VersionOne. cPrime provides classroom training that includes hands-on exercises with real-life scenarios to equip team members. Additional tracking tools designed to follow and validate development throughout the lifecycle, with review and signatures obtained in order to comply with regulatory requirements, may also be selected.
Implementation of Agile: The Pilot Projects
Once a pilot project is begun, the transition to agile is modeled, including how to conduct Scrum meetings. These 15-minute daily meetings look at:
- What problems are being encountered (that can cause “drag” and reduce team velocity)
- What is currently being done
- What needs to be done (priorities for the day)
Scrum meetings improve collaboration and allow more cohesive working together. The goal is to identify ways to improve workflow, and to address any problems.
cPrime provides healthcare clients with Scrum and sprint templates, which are customized to show process compliance for regulatory agencies. Documentation and organizational quality standards, which were defined during planning, are now maintained during pilot projects.
Initial training for Product Owners and Scum Masters in their roles is done, with practical practice in
- Defining user stories to capture requirements: Product owners meet with clients/stakeholders to learn the features they want, what the finished development must be able to do, and to define FDA or other regulatory requirements, if applicable.
- Any additional quality process/regulatory steps that must be completed before story acceptance
- How to refine stories, assign points and priorities and create the Product backlog. Training is provided in how to update the backlog as new features are requested.
- How to enter tasks into the sprint backlog.
The shorter iterations (sprints) in agile require specific training in estimating hours instead of days for team members. But over time, these shorter lengths allow much more accurate estimates of time and resources, which in turn reduce project risks and cost overruns.
Sprint Planning meetings between the PO and the Team are first modeled by cPrime during the transition to agile, then mentored, as the teams become increasingly familiar with and finally independent.
During implementation, the cross-functional teams learn how to develop the highest priority items during a sprint (normally, these last two to four 4 weeks). Daily scrum meetings are first modeled by cPrime staff, then mentored. These short (15 minute) meetings allow team members to identify any issues that could create “drag” and reduce velocity, and prioritize their work for that day. A Burndown chart in the “War Room” (where Scrum meetings are held) shows visibly the progress to date on the sprint backlog.
Sprint reviews and retrospectives are mentored, when the team shows management and stakeholders the result of the sprint. This allows feedback between stakeholders, product owners and team members, to improve communication and support collaboration and engagement. Suggestions for improvement are then taken into the next sprint.
The goal during agile implementation is to improve not only velocity, but improve total software quality, and promote greater stakeholder/user satisfaction with the end product.
Improved Productivity for Healthcare Software Developer Directly Related to Agile Implementation
iSirona offers a software-based solution that moves device data from medical devices into EMRs. The company’s software was developed in accordance with the FDA’s quality system regulation controls.
Before iSirona implemented agile, they had a very formal waterfall development process. However, waterfall methods were causing delays in shipping products out to customers. cPrime came onsite, assessed their environment, and recommended changes that would offer the greatest value and would work within their corporate environment.
We conducted Scrum training, and coached/mentored teams through early Sprints, as discussed above. As the iSirona teams became familiar with using Scrum and agile methodologies, they became independent and began to enjoy the benefits of agile methodologies, while maintaining regulatory compliance. The result: after implementing agile, team members were able to develop and deliver products on a timely basis, and their desired production goals were achieved.
Choosing to adopt agile and Scrum methodologies is helping numerous healthcare organizations and medical device manufacturers enjoy improved productivity, improved quality, and better support for healthcare delivery.
- Natale, Carl. “Healthcare IT faces unspecified challenges in ICD-10 implementation.” Government HealthIT, 6/1/2012; article online at http://www.govhealthit.com/resources/blog/healthcare-it-faces-unspecified-challenges-icd-10-implementation
- Roney, Kathleen. “5 Differences Between Static Data Warehouse Design & Agile Data Governance;” Becker Hospital Review. 1/31/12. http://www.beckershospitalreview.com/healthcare-information-technology/5-differences-between-static-data-warehouse-design-a-agile-data-governance.html
- “U.S. Food and Drug Administration publication, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” 5/11/2005. Available online at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm
- Abbott Laboratories. “Moving to Agile in an FDA Environment; An Experience Report.” Presentation given at Agile Alliance 2009 conference on August 27, 2009. Available online at http://c-spin.net/2009/cspin200909Agile_In_Regulated_Experience_Report.ppt
- Spence, Jon. “There Has to Be a Better Way.” Publication from Proceedings of the Agile Development Conference (ADC) 2005. Available online at http://www.researchgate.net/publication/4231042_There_has_to_be_a_better_way!_software_development
- Deitsch, Andrew; Hughes, Ross. “GE Healthcare Goes Agile: Imaging Unit Takes Control of Its Development Environment and Likes the Results.” Dr. Dobbs online, 12/06/2010. Article online at http://www.drdobbs.com/architecture-and-design/228300298.
- Leonard, Devin; Tozzi, John. “Why Don’t More Hospitals Use Electronic Health Records?” Bloomberg Businessweek article, 6/21/2012.
- Robert Wood Johnson Foundation; Mathematica Policy Research; Harvard School of Public Health report. “Health Information Technology in the United States: Driving Toward Delivery System Change 2012.” http://www.rwjf.org/files/research/74262.5822.hit.full.rpt.final.041612.pdf