Quality Management for Software as a Medical Device

Quality Management for Software as a Medical Device

April 4, 2019 | Posted by Sean Carroll

Successful quality management for Software as a Medical Device (SaMD) will have 3 preeminent distinctives:

  1. It will ensure the product's agility over its development life-cycle, from design to retirement;
  2. It will insist on user-oriented functionality and interfacing, designing and deploying for discrete end-user environments and competencies; and
  3. It will maintain promptly-updated accessible documentation throughout.

Driving all of these factors is the paramount concern for patient safety and the security of sensitive data.

Agility will be required in multiple dimensions of a given SaMD project. The product plan should be viewed as dynamic, not static: it must be able to accommodate new information, changing requirements or compliance standards, developer insights, results from environment-specific and user-specific testing, and so on. Putting clear & consistent decision-making workflows in place early (read more: Agile in Medical Device Development; Know Your “Why”) can go a long way towards facilitating implementation and documentation (see below) of a dynamic plan.

One way that we at Velentium accomplish this level of agility is by keeping levels of separation between developers, clients, quality managers, and so on, to an absolute minimum. We don't believe in playing “telephone” through a network of bureaucracy; instead, we believe that each member of a product team needs to have an “all-levels understanding” of what he or she is helping to build. If you're working with us, you're not focused on “your piece” of a bigger puzzle: your contribution depends on seeing the whole picture.

Agility is also critical to deployment of SaMD: it's not unusual for SaMD deployment to incorporate clinicians, hospital IT, risk managers, and others who are not part of a typical software deployment. These plus others, including end-users, may also be involved during maintenance (installing updates, downloading usage data). Quality management requires anticipating these variables, as well as having a plan in place for responding to unanticipated ones. Agility in these phases should be understood as the SaMD organization's ability to preempt and/or respond to unintentional security threats and foreseeable misuse, in addition to deliberate attacks and problems with normal operation.

To accomplish this, quality management must adopt & maintain a user-oriented posture. From forming a development team fluent in clinical aspects of the SaMD's applications and the socio-technical environment in which it will be used, to designing a product for users who will not only vary in technical ability but may also vary in physical ability (for example, in eyesight or fine motor control), to supporting the product in a way that mitigates risks that widely varied users may introduce, the product's end-user and usage environment must be kept in sight at all times.

For a Velentium SAMD project, I went on-site with my team to the hospital to meet with clients and end-users – nurses, medical division heads of staff, data managers, etc. My work, and our work as a team, depended on us understanding use-cases. We simply couldn't build a quality product otherwise.

Lastly, agility and effective user-orientation can be successfully sustained with a system of accessible documentation. When changes are decided on, when new data is considered, records should contain not just the action-item to be undertaken but the rationale for that action as well. Updated documents should be pushed out to the whole SaMD team promptly, and should be readily identifiable to prevent version-confusion. Maintaining these regularly-updated, easily-accessed records builds trust, both internally between development and management as well as externally between organization and client. It also permits navigation of complex & dynamic workflows, cuts down on second-guessing of decisions, improves dependable communication, and overall works to reduce risks for the end-user – the ultimate goal of SaMD quality management.


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