Creating successful healthcare software – from patient management systems to medical devices, to electronic medical records – differs substantially from traditional software.
Healthcare software demands unique domain expertise, project methodology, and software architecture patterns. While many vendors and consultants would insist that good software practices and user-centered design principals are universal across domains, we believe that healthcare projects are different. Healthcare domain expertise, combined with software best practices, can significantly improve your project’s chances of success.
The Risks are High
Unfortunately, our industry continually underestimates the effort involved in getting a new software system or medical device to market. Passing CCHIT certification, for example, can cost upwards of $200,000 depending on the amount of rework involved, according to a comment made by Sam Bowen, president of Open Source Medical Software. Medical device verification and validation can unexpectedly account for a major portion of a project’s effort – often making up 33% to more than 50% of overall development costs.
When the software is finally delivered, it is by no means a guaranteed success. Failed healthcare software system stories abound – from Cedars-Sinai medical center electronic medical records system after investing $34M to Kaiser Permanente abandoning an attempt to build its own clinical system with IBM and writing off some $770M in software assets. Even among the fraction of physicians in the United States who do use some form of electronic medical records within their practice, more than 30% say they would not recommend the software to others.
10 Critical Lessons
We intend to provide software R&D teams, software development managers and product managers with insight into the most important aspects of clinical software development. Focusing on 10 critical lessons, this paper offers concrete examples and advice gleaned from years of healthcare software development and project management experience. These examples touch upon topics that include architecture for privacy law compliance, database design, hospital process integration, verification and validation, and special user requirements.
10 Critical Lessons Learned Developing Healthcare Software
In this whitepaper, we outline the top ten lessons learned relative to specialized user requirements, architecture for regulatory compliance, database design and more.