SPK helps a renowned medical device maker to add speed, visibility, metrics, and improved communication and collaboration to their teams tasked with creating product labels and user manuals.
The Client
A globally recognized maker of medical devices was tasked with creating a lot of highly technical, precise, and regulatory-compliant documents, specifically, 1) product labels, and 2) product instructions.
This is a surprisingly complex and technical task, which is assigned to largely non-technical people: Writers. There are 35 people on the team, and their assignments are daunting. A single product could include anywhere from one to 50 different labels. The IFU, or “instructions for use,” could be a one-page card—or a 1,000-page user guide.
The workflow included original tasking, gathering input and feedback from scores of subject matter experts or SMEs, re-writing, reviews by legal, tracking, production… and translation into more than 18 different languages.
Interestingly, this process of the non-technical people had a technical flavor to it: It was similar to the creation of software, with its development, quality assurance (QA), and production phases. Thus it was an ideal candidate for moving to a software-like development process. And so this client tapped SPK to help.
Can-Do Kanban
The team had never used a Kanban board before, but wanted to. A Kanban board is great for small pieces of individual work (in contrast to, say, agile/iterative software development). Picture it as a visual representation of a board with little “cards” on it, representing tasks, organized into “swimlanes” according to roles and responsibilities. As a project progresses, its card moves across the Kanban board from start to finish.
Now imagine a virtualized version of that board, and you’ll see what SPK needed to create.
Fortunately, this medical-device maker already had a licensed Jira implementation, which is used for ticketing and requests. Our job was to create a virtual Kanban board… on Jira.
The Solution
SPK worked with the client to map out their existing documentation process, and update it for the new way of working. We created two new Kanban boards in Jira Software, one for the labeling projects, and the other for the technical user manuals. The new labeling board has 15 steps; the documentation board has 13.
SPK was able to not only adapt the steps, but also eliminate some that would no longer be needed/translate to the new system.
There were a lot of other old-school workarounds that, fortunately, were left behind as well:
- In the old way of working, the project manager or team member would rely on email for communication. Imagine trying to track lots of different SMEs’ ongoing feedback that way, without letting anything slip through the cracks.
- And they would use other tools and systems as needed: OneNote. MS Teams. Word. Outlook. It was all over the map.
- It was hard enough for individual contributors to keep track of this. Their managers had virtually no visibility into the big picture or process details.
Using the existing Jira license, SPK was able to configure the new Kanban boards in just 1.5 weeks, with no special configurations or plug-in’s required. It was fast and incredibly cost-effective.
The Benefits
What once had been scattered (and hidden) across lots of different, home-grown systems is now unified, simple, and efficient. There are two Kanban boards: one for labels, one for IFUs. And a project is basically like a “ticket” in Jira, as it moves across the board.
The benefits are manifold:
- For the first time, teams actually have metrics for the business unit.
- Team members can easily communicate project status.
- Users can easily request deliverables to the teams that can be tracked.
- SMEs can easily communicate their feedback.
- Team members and managers can run reports on items accomplished for the year for reviews.
- Managers can actively see what all team members are working on—all in one view.
- One-to-one meetings with team members are more efficient, because deliverables can be viewed and discussed directly from the Jira board.
By the way, the existing Jira environment saved this company more than time. A from-scratch Jira setup of the new boards, along with the accompanying configuration, would have cost anywhere from $15k to $30k. The client didn’t have to spend an extra penny on Jira.
Deliverables easily tracked
Metrics available, for the first time
Time saved
Other parts of the “system” were equally creaky:
- For one program, they had been using a partner’s design-controls system, but found the tools to be inadequate, and the process of updating requirements, tests, and risk analysis to be slow, error-prone, and cumbersome.
- They had been using an older, on-premise installation of PTC Integrity Lifecycle Manager purely for source-code control, and a very old on-premise PVCS Tracker system for bug tracking and change management of the source code. The Integrity system was several years old; the PVCS Tracker was so old that it had already been deprecated (read: “no longer supported”) by its manufacturer.
- The company’s internal IT department was over-burdened with the prospect of trying to manage outdated on-premise systems; this underscored the need for a migration to the cloud.
A Multitude of Requirements
Clearly, there was a lot of room for improvement—but there were numerous considerations:
- The new design-controls solution would integrate requirements management, risk management, test management, change management, and source code management. This would ensure that the company was fully compliant with the necessary medical-device regulations such as ISO 13485, the Quality Management System standard for Medical Device manufacturing; ISO 14971, the Risk Management standard for Medical Devices; and IEC 62304, the Software Development Lifecycle standard for Medical Devices.
- Speaking of compliance, the new solution would need to meet FDA requirements, and those of the company’s own internal Quality Management and Regulatory auditing teams.
- Importantly, PTC Windchill RV&S is a highly configurable application lifecycle management platform—but out of the box, it doesn’t implement any processes. PTC provides its partners and application engineers a standard solution template which is very generic. But it’s loaded with demoware, which is good for demonstrating the potential of the product, but not necessarily a good starting point for configuring a customer-specific solution.
How, then, did SPK and Associates rise to meet these manifold challenges?
The Solution
SPK and Associates implemented a tailored Design Control solution that was based on the SPK Medical Device Solution TemplateTM. This is a streamlined configuration that’s optimized for medical device product development.
It starts with the out-of-the-box PTC Windchill RV&S platform. But it then pares down the configuration, leaving out all of the demoware and other extraneous features. This is because the computer system validation (CSV) requirements for the medical device industry would require that any such extraneous features be either removed or disabled—and then their removal or disabling verified.
Thus by starting with a clean configuration that’s optimized for medical-device development processes, the customer configuration could then be developed and certified much more quickly than by creating a custom solution from scratch, or by attempting heavy reconfiguration of the generic PTC systems-engineering solution.
- Today, the company enjoys one-click full traceability via the SPK Report Engine™.
- They benefit from a private validated cloud environment hosting PTC Windchill RV&S.
- SPK provides computer-systems validation (CSV) covering IQ, OQ, and PQ (Installation Qualification, Operational Qualification, and Performance Qualification, respectively) for the company’s PTC Windchill RV&S intended uses.
- SPK provides application management support for the new environment.
The Benefits
- Requirements and test management are now completely integrated and traceable.
- Risk management is now available, meeting FDA requirements.
- Traceability exception reports are now available at the push of a button, saving several weeks of manual effort.
- SPK and Associates helped this company to improve their overall product-development efficiencies for risk management, requirements management, and test management, shedding weeks off the development/release cycle.
We are so thrilled with our new Kanban boards and how much time it saves our team. Before, we couldn’t keep track of where the project was, and tasks were being dropped as we all tried to manage everything in email. SPK easily set up our boards and trained us — it is so much better!
Get a no-obligation initial assessment
Whether you’re trying to solve technical problems, implement new technology tools and strategies, or improve efficiency, SPK and Associates can be a key part of your strategy. We can provide a free, no-obligation initial assessment on almost any technology or engineering situation. Contact us today at (888) 310-4540 or info@spkaa.com.
