For medical device manufacturers, new realities present favorable circumstances and worrisome challenges. For example, medical devices are now more integrated into inpatient, outpatient and home care. And technological advances continue to evolve medical device design and manufacturing. But as modern health reform increases patient connectivity, it also increases media scrutiny, leaving manufacturers with precious little margin for error.

Medical technology companies especially those developing medical devices are faced with a wide range of techniques for managing risk.  The hardest part is often deciding which specific techniques and data points need to be captured to demonstrate that all angles of risk analysis for the product have been accounted for. Today, many medtech companies are using spreadsheets to capture risk […]

It’s hard to visualize how a system will function just by reading the requirements specification. Designing tests based on requirements will help make the expected system behaviors more tangible to all the project participants. And the simple act of designing tests often reveals many problems with the requirements long before you execute the tests on an operational system. In fact, […]

Semiconductor engineers in the automotive industry understand the fundamental importance of requirements management (RM), but many critical stakeholders don’t. The challenge with this disparity comes when implementing RM in a modern development environment. From technical specs hundreds of pages long to coordinating cross-functional deliverables, the complications are abundant. Additionally, engineers face rapid advancements in algorithmic reasoning, semiconductor memory and sensor […]

Managing software projects is difficult under the best circumstances. The project manager must balance competing stakeholder interests against the constraints of limited resources and time, changing technologies and high-pressure demands. Anyone can learn to draw a Gantt chart, but effective project managers rely on the savvy that comes from experience. Learning survival tips from people who’ve already done their tours […]

Every year, the complexity of projects increases. The average requirements document is over 100 pages long and changes 20 times during the development process. Any Business Analyst or Project Manager responsible for maintaining a requirements document will likely spend hours circulating, editing and tracking changes – often using Word, Excel or email – with the hope that the team stays […]

Executing a successful development program on time and on budget has always been a challenge for government agencies and partners in the aerospace and defense (A&D) industry. With today’s relatively flat economy, globalization, product sophistication and the continuing emergence of new technologies, the level of complexity in A&D product development is now staggering. Additional complications include complex contract vehicles, intricate […]

What do golf and automotive software have in common? To the novice, seemingly nothing. However, the commonalities are more profound than expected. Consider common traits of golf and ISO 26262 as experienced by this author: • Both seem easy to start up, but complexities befuddle beginners • Both seem cheap to engage in initially, but become more expensive once they […]