A Brief Discussion about Standards and Regulations
We're sometimes asked about issues such as product standards, regulations, and related matters. These are points worthy of considered thought and we have spent a significant amount of time on them. Our stance is simple: we always follow existing rules and established norms but understand that things are not as straightforward as that.
The nature of innovation, exponential technology, and other ongoing developments have put most regulatory bodies on their back foot. For example, it was only last year that the US Food and Drug Administration (FDA) issued non-binding guidance for “Technical Considerations for Additive Manufactured Medical Devices.” The vitally important work of that particular agency is providing "safe and effective" standard for evaluating food and medical products do not equally extend in the same way to the tobacco products it also oversees. Other regulatory groups have similarly found these issues difficult to navigate. In our own sector, the Sphere Standards have been regularly reissued since they were first issued more than two decades ago.
For our own work, we have developed a very effective way of assessing risk and readiness of each piece of hardware we work on. This involves a thorough engineering review and follows on from original concept through distribution to the end-user. This involves a three-stage risk assessment:
1. The evidence is collected not only about technical issues but the context in which an item will be used. This involves comparing the proposed Field Ready solution with a ‘gold standard’ solution, whether that is a comparable device or another means of achieving the same intended outcome. 2. All hazards relevant to an item are listed and scored to allow a common risk rating to be given. 3. Consideration of risk control measures is made with the highest priority given to risk reduction by design, followed by protective measures, and only where these cannot reduce the risk fully are instructions and guidance considered. Consideration of risk control measures is followed by a further scoring to produce the residual risk score.
Another issue sometimes raised in our work is intellectual property (IP). Typically, only people who have little background ask about IP. But those with experience know that, while important, myths and misunderstandings about IP abound. And that nearly all actions taken to protect IP are defensive and are often unnecessary. In the commercial sector, many feel that the best practice is this: things are often left best as “trade secrets” (which are not legally protected) so that more pressing issues can be addressed. This is especially true when dealing with creating hardware (in contrast, art and inventions, such as those involving formulas, gain more benefits from IP protection). This set of facts is one of the primary reasons that Tesla, the automobile company led by Elon Musk, has made all their patents open and public.
For ideas to constitute IP, and thus qualify for protection through mechanisms such as patents, it needs to be “novel” (i.e., new and not obvious) and plausibly made and used (i.e., it has to have “industrial applicability”). If these conditions are met, each new “embodiment” of a product or invention can be count as new IP. This means that a single change to a process, application or function can be new IP. For this reason, commercial companies apply for numerous patents on potentially profitable products in a technique called “picket fencing.” Also, for this reason, patent lawyers try to write applications using wording as broad as possible.
Further, legal protection (as well as the standards and regulations mentioned above) can only extend to the extent of the jurisdiction of the authority issuing the protection. So if the Canadian government issues a patent for a medical device adapter, it does not automatically apply in the US and vice-versa.
This blog only touches on a few of these complex issues. There are many other issues here such as the changing nature of regulations, trends and hype, new technologies and the like. This will remain an evolving topic which is not the business or responsibility for a non-governmental humanitarian organization to reach conclusive positions on (i.e., it’s the job of others to figure all this out).
But here’s the bottom line: Field Ready will always respect standards, regulations, and IP where they are clearly in place, relevant to our work and do not compromise our commitment to the humanitarian imperative of saving lives and reducing human suffering.
To see the full system of measuring readiness and risk used by Field Ready, please see our “Parts Catalog” available here.