I can’t believe we have less than three weeks left in Costa Rica. It feels like only yesterday that I waded through the airport into the fresh Tico air. With the clock ticking, I am diligently finishing my project. I presented my design process plan to my supervisor and the vice president of quality the past week, and while it did have some important details, there were still some key elements that needed to be added.
One element was the design freeze. A design goes through product development, which involves the initial identification of the opportunity through planning and the actual design cycle. There are design reviews along the way that can help with the final submission to regulators. But after all that, there needs to be a “design freeze” where all design is finished. This ensures there is one, discrete product ready for market and that documentation is ready for regulators. With a robust product development design, any changes that were planned should have already been made by this time.
After the freeze, the design is validated and set up for manufacturing and the product is launched. But not so fast! That’s not the end of the paperwork yet! In fact, it never ends. It is vitally important to maintain documentation of any post-launch design changes in response to real world feedback.
When looking at the process on a macro level, it is important to see that these stages are moved through with time. There isn’t much concurrent processing happening. It moves in a sort of step-wise waterfall manner (sound familiar?).
I put the finishing touches to the design and presented it Friday. It was met with resounding applause and calls for an encore. (OK, maybe not that enthusiastically, but it was definitely well-received.)
Now I will need to develop checkpoints along the process that will help meet the requirements set by FDA and ISO regulations. Fingers crossed, these checkpoints will be comprehensive enough to develop documentation that can then be compiled and passed off to regulators. It’s like a school project: the teacher (regulators) may only check the finished project, but you can only really build an efficient project if you develop the deliverables along the way, rather than play catch-up at the end. Breaking down the FDA regulations into discrete requirements has helped.
Meanwhile, the Consultika team got in touch with a gynecologist who will serve as the physician expert for our implementation project. She, herself, sees the benefit Consultika can give since she sees patients who must travel far to be seen by her. The current solution of using WhatsApp is not secure and risks patient privacy. Secure communications can allow her to decide which patients should make the trip to see her and which patients can be successfully treated where they are. The long distance, especially during the rainy season, can be an all-day affair.
And in recent days, the rainy season in Costa Rica has definitely ramped up, with the rain causing mudslides, flooding, and road closures. Adapting to the weather has been a challenge, but the GMIers are fortunately doing well. On any given day you may see me lugging around an umbrella, and the days I forget it are, of course, the days it rains.