Medical devices often come into contact with patients, and users. Sometimes repeatedly. Addressing patient and user contact is a critical aspect of medical device development. Biocompatibility is a significant aspect of contact, but what about sterility? And if a device does not need to be sterile, then how clean does it need to be?
Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]
Navigating water ingress in medical devices can be tricky, as one of the key requirements for ISO 60601-1 is the protection against ingress. With so much development focused on the functioning of the medical device, ingress protection can be overlooked or left late in the development phase as something that is easily solvable.
There are so many methods available to prototype that I’d like to expand upon an earlier blog. In this article I share the low-cost tips and methods on how to prototype a medical device on a budget that I use in my New Product Introduction (NPI) work. Just as importantly, I explain when I use […]
It behooves designers to look at the assembly processes early, with a focus on how we can stop critical faults or those that are likely to happen. Process Failure Modes and Effects Analysis (PFMEA) is a tool to assess potential process failure points during assembly and how the failures could be felt or observed by […]
I was recently asked if I knew USP class VI is another standard that’s often quoted – the two standards are similar in some respects, but are not equivalent.
When developing a medical device, it’s easier both in time and effort not to reinvent the wheel. Sometimes, off-the-shelf (OTS, or COTS – commercial off the shelf) components don’t meet the device needs, and usually these deficiencies are obvious. The problem arises when we unconsciously ask for more than the original widget design requires.
“What’s the difference between production tooling vs prototype?” and “What quality can I expect?” are often questions that I get asked from development or clients. The best answer begins with other questions: “What quality do you really need?”, and “How many are you making?”
I once had an argument over a design given to me by an industrial designer. The design was difficult to manufacture, and I knew would cause some significant manufacturing challenges. There was one particular edge, one particular surface that would have been so much easier another way, but the designer was sticking to his guns. […]
We’ve become so used to stainless steels being stain-free, that we are shocked when we see rust on them. While the conditions required for stainless steel rusting are more likely to occur in medical lab equipment where stainless and salt solutions come together, it can happen in any device, including implants: A first thought is often […]
CAUTION: Overhead ahead One of the biggest mistakes start-up companies can make is underestimating manufacturing costs. The tendency is to focus on the cost of the components, i.e. Bill of Materials (BoM) costs. They’re important, but costs don’t stop at the BoM. Depending on the nature of the device, other/overhead charges can overshadow the costs […]
Earlier this year, a colleague of mine at StarFish Medical wrote about when good is good enough: I’d like to expand on those comments regarding defining scope of work, adding that good enough can be great.