At Zimmer and Peacock, we are contract developers of electrochemical sensors, including the construction of sensors within microfluidic cartridges.
A common question we are asked is ‘can you manufacture us several million pieces per year, and we would like them at 10 cents…’
The answer to this question is yes, but there are caveats. In order to manufacture a piece in high volume, with high yield and within tolerance takes considerable effort, and effort inevitably translates as money.
If we use the diabetes market as a case study there the large manufacturers are able to produce glucose strips using reel-to-reel production and produce products which cost them 5 to 10 cents to manufacture. This ability to rapidly manufacturer product has taken the industry billions of dollars of investment, with the large companies making the large investments and then the ‘me-to’ manufacturers copying later on.
The success of the glucose strip has set an expectation in companies both big and small, that in order to manufacture their electrochemical biosensor and/or medical diagnostic then they will be able to contact a company such as a contract screen printer, have their pieces made say for 5000 USD or less and the result is a beautiful sensor that is ready to go.
One of the silent problems in the industry is that these pieces are often untested, they maybe visually inspected but none of them are functionally tested.
There are two problems with this, sometimes there is contamination of the product and a visual inspection can’t tell you how well the part will function.
Please see these two notes on this issue.
These are minor problems relative to the big problem. The big problem is really one of expectation. A rhetorical question that puts expectations in perspective would be ..If low cost biosensors and medical diagnostics were so easy to produce, why is the market not flooded with products… Often when a company is working on a biosensor related product they reach out to a contractor they receive a quote where the company is willing to make several thousand pieces for a few thousand dollars/euros. The contracting company will receive these parts, but these parts never/rarely function in the way the company was expecting. In effect expectations were not met.
At ZP we know that to make a biosensor/medical diagnostic that is within expectations takes investment and at least 5 manufacturing steps:
1) Step One – Prototype manufacturing
2) Step Two – Pilot manufacturing
3) Step Three – Alpha Manufacturing
4) Step Four – Beta Manufacturing
5) Step Five – Manufacturing
At ZP we are very used to supporting businesses and entrepreneurs get to market, but as well as providing the services we are able to advise on what it really takes.