Posts by Martine Janicki

Very few first product realization versions meet the expectations of end users. That is normal and should be anticipated and addressed with “enterprise business agility.” Managing evolving requirements is now a core competency given our changing business requirements (and technical specifications) based upon a better understanding of the likes, wants and dislikes of health care […]

Three years ago I migrated from medical device design and development to the client side of Digital Health. I had the privilege of leading and managing components of transformational initiatives related to Electronic Health Record, also known (and preferred by users) as Clinical Information Systems. This experience changed my thinking about medical design excellence.

Is Device Generated Data part of your medical device plans? We live in a digital era, and if you are in the medical device design and development business, it may be wise to think digital health. There is an undeniable shift from stand-alone technology to integrated systems even for devices with specialized functionality. Granted, devices with […]

Do not underestimate! Defining the overall critical path (and critical path bottlenecks) may be onerous, and somewhat of a cliché, but it is a concept that is very real for project success. Developing a realistic baseline project plan is always a daunting task, particularly when the project sponsor requires a high level of accuracy for financing purposes. […]

The domain expertise required for a medical device development program should not be under-estimated.  After all, the goal is to develop an innovative new medical device with proven clinical efficacy for a new market.  Engineers, software developers, business analysts and regulatory advisers all play a unique role in the project team.  Efficiently integrating a distributed […]

In 1999, I had to source, negotiate, and implement an integrated monitoring system for ICU. This basic system networked bedside computers to a central nursing monitoring system and was considered innovative, effective and clever. Fifteen years later, electronic medical files and data sharing between imaging modalities, laboratory tests, pharmacy prescription listings, and MSP formulary plans […]

Medical Device Multi-Disciplinary Teams Outperform Solo Efforts Goodwill, cooperation, and camaraderie are more than holiday spirits around the StarFish office these days.   Working in isolation is not an option for medical engineers. Those still confined by ideas of belonging to a unique discipline will have a hard time moving forward in an increasingly complex and […]

The first edition of ISO 21500 Guidance on Project Management was published in September.  Prior to the publication of ISO 21500, project management practice was guided by the Project Management Institute (PMI®), an international not-for-profit professional association with over 700,000 members and volunteers advocating for the project management profession and responsible for the project management […]