Another whirlwind week at Establishment Labs comes to a close. Things ramped up fast, as I embark on creating a design process that meets regulatory requirements of various countries. It must adhere to the regulations of various countries. Thankfully, standards such as ISO exist, allowing for easy cross-compatability with other countries’ regulations. It’s only easy, of course, if ISO standards were easy. But the tome that is the ISO standard has numerous guidelines for medical devices, and the design process is no exception. These guidelines are not strict measurements of tangible objects, but rather prescriptions for checkpoints along the design process. From conception to testing to refining to in the wild, medical product design needs to have rigorous documentation. The focus is ensuring if the design process is executed well and on target. In other words: did we do the thing right? Does the product fulfill the intended goals? And did we do the right thing? Does the product solve the problem correctly? To prove this focus for regulatory agencies, medical device companies have designers and managers check things at every step of the design process.
This took me by surprise. In the past, when I thought about standards, they seemed like one-dimensional hoops companies had to jump through to satisfy basic safety requirements. But if you really think about it, there’s no reason why standards shouldn’t be applied to processes such as design. Should a heart valve be developed through sheer guesswork? Or should there be a methodical approach to it? And shouldn’t the methods be expected of all medical device companies? Quality is not just in the final product, as I learned. It’s in how the product was made as well. Failing to plan is planning to fail.
It’s a lesson that I’ll carry over to my implementation project, the exciting Consultika project. During the academic year, I, along with a few of my distinguished GMIers, will be working to implement this secure messaging service for Costa Rican doctors in order to better protect patient privacy. We’ll set into motion a solution crafted by GMI cohorts before us. So how does quality play into that? Although I have had my fair share of hacked together solutions in my life, implementing a service to be used as an aid for medical care would require that each step of the process is deliberate. We need to ask ourselves plenty of questions: What are our goals? How do we plan to achieve them? Did we achieve them? Does our implementation fulfill the identified need? Whilst asking ourselves these questions, we also need to document our answers to show to ourselves and to others that we are creating a service that safely and effectively helps patients.
In the end, it’s all about the patients. You only get out what you put in. To get a quality medical device, we need to put in quality work, every step of the way.
Hospital Enrique Baltodano, Liberia, Guanacaste, Costa Rica