4 Years Forward, 40 Years Wiser
Happy Birthday to Moberg Analytics!
Moberg Analytics turned 4 years old on April 20th, 2024. When you send in the corporation documents to start a company, you wait for them to be reviewed, and if everything is OK, they stamp them with the date and that becomes your incorporation date. Our date, quite randomly, came up as April 20th. It wasn’t until later that I realized the significance of the date “4/20”.
I’m sure many of our readers know that 420 is a code referring to cannabis and thus the odd coincidence of our company, whose mission is to promote brain health, being formed on that date. For those not familiar with the term, here is the story in Wikipedia. Apparently, five high school students in California would meet at 4:20 every afternoon to smoke pot and they used 420 as a code for the meeting. High Times magazine wrote a story on them and the code spread.
Today, there are 420 celebrations around the world, traffic signs are stolen that have 420 in them, and, it is rumored that Elon Musk priced his Tesla stock buyback at $420 a share as a subtle reference to this culture. So, the company followed suit and had a 420 party to celebrate our birthday… but with cake, not cannabis… again, promoting our mission.
The team celebrating our 4th birthday and 4 years of excellence before happy hour!
In reflecting on these four years of the company and comparing them to the past 40 years of developing medical products, quite a bit has changed, some for the good and some not so good. I’ve been amazed at how fast you can turn ideas into products these days. As an example, we used to have to tape the tracings in a printed circuit board by hand, meaning every conductive connection was a piece of tape pressed onto a large clear plastic sheet. The sheet was photographed and the copper clad boards were etched according to the photo. This took weeks and invariably there were mistakes and you had to do another turn of the boards.
I hadn’t been involved in this process for a few decades when we had the need recently to design a stopcock position sensor to annotate data recorded from an EVD. The engineer working on it showed me the circuit design one day, which we approved, and in two days he had the finished board. The design tools and processes have been so automated that hobbyists can make circuit boards which was unheard of two decades ago. And likewise with the software development process, the rapid retrieval of information, and many other engineering techniques.
On the disappointing side, the regulatory environment has become overly burdensome. My first submission to the FDA in 1981 was 12 pages long, and we basically told the FDA what our product did and how we were planning to market it. It was approved in a few weeks. Today, the submissions are a significant cost and resource hurdle for device manufactures and are determinants of the company value for investors. The Quality Management Systems (QMS) that are required throughout the product life cycle are based on guidance that can be confusing and conflicting.
Many smaller device manufacturers choose not to sell to a country due to the regulatory burden versus the expected revenues from that country. To be clear, I’m a big proponent of quality design and product safety, but today the burden of the regulations seem to be more important than the value of the device to the medical community, which seems to defeat the purpose of developing the product in the first place. There are steps towards developing harmonized standards that would be accepted worldwide which would solve many problems.
In summary, these past four years, when compared to the past 40, have been like living in a different world. And I wonder what my next company will be like (that’s kind of a joke). Will ChatGPT connected to automated manufacturing be developing the products? It’s hard to tell these days if that will be better or worse. Regardless, Moberg Analytics is ready for whatever comes next.
Moberg Analytics’ 4th birthday cake
