1. Break-out Session I Group II: Medical Software and Systems Engineering HCMDSS November 16-17, 2004 Arlington, Virginia

2. Challenges and Opportunities Teaching engineers to write good requirements is non- trivial “Everyone” (sometimes, even within the same organization) has their own style/approach hinders traceability need systematic training to “standardize” Sometimes the people with strongest control over requirements are marketing people Need alternatives/supplements to natural language requirements strongly tie requirements/mock-ups/prototyping Need more ways to leverage requirements light-weight formalisms that can be animated/visualized in several ways with multiple forms of tool support Writing Good Requirements is Difficult!

3. Challenges and Opportunities Reference architectures “Software product-line” architectures Need reusable artifacts from certification process reusable certifiable components and infrastructure Need more reusable aspects of development process

4. Challenges and Opportunities Currently very difficult Little tool support Risk Management

5. Challenges and Opportunities Medical experts are sometimes dictating the software development architecture/process Systems engineers/development misinterpret requirements because they don’t understand the domain Mismatches between domains

6. Challenges and Opportunities Need methods to overcome loss of good practices due to high turn-over Need better documented, repeatable, development process

7. Research and Development Needs Need tools that re-enforce development processes Testing contributes 50-60% of costs, so need tools for automatic test generation, test prioritization Broad perspective on development of medical devices

8. Logistics to Meet Research Needs “Open Experimental Platform” for High Confidence Medical Devices Funding agency pays for… …vendors to develop representative examples of certified systems …vendors to provide description of development process …vendors to provide “challenge problems” to researchers …vendors to provide “face time” to meet with researchers and evaluate developed tools against base-line development processes Positive Examples of DARPA-funded OEPs… Avionics Mission Computing OEP from Boeing Automotive Control System OEP from Ford

9. Workshop Recommendations Multiple project leaders from different organizations get together ahead of time and prepare a report of strength and weaknesses of current development Perhaps a Panel Discussion tied to the above Broad perspective on development of medical devices

10. Workshop Recommendations Have someone (FDA, industry groups?) prepare canonical, open-source examples with complete set of certification artifacts Brief on the above… Have a collection of specific Challenge Problems presented put together by groups from industry and agencies Canonical, shared examples and Challenge Problems

11. Workshop Recommendations Quality of service issues… Power management… Dealing with internationalization products are not just developed for US market Additional topics…