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Week 15 – Improving Our Processes

Hope all is going well. If your weather is anything like ours, I hope that you are staying cool as the dog days of summer are upon us. It seems like high temperatures are world-wide, higher than they have ever been on record. Sadly, in this case, change isn’t always a good thing. For us, the past few weeks at the company has been focusing on change. In our case, it is planning for potential good changes. Our products are currently being evaluated as stand-alone devices, as coatings onto existing devices and as scaffolds to grow different tissues of the body. Several companies are also looking at many other new applications for our technology, including cellular agriculture. Cellular agriculture is the concept of growing meat in large volumes, similar to how large vats of beer is produced. Very exciting times at the company to say the least! The change I am talking about is not necessarily about what we are working on now, but what we will be working on in the days, months and even years from now. We currently have the ability to produce needed quantities of our devices and benchtop scaffold products. We are already selling several of our products to various partners and customers. We are fortunate in that our company has the ability to generate revenue, which is not common for biotech companies. So why is it important that we think about the next steps so early? What if one of these partners or customers determines that they need 10 times the amount of the product we are currently making? It would be tragic to have a large order and not be able to fulfill it. It would be like throwing money out the window as we are driving down the road.

Change can come in several forms such as in the process you are performing, the equipment you are using to make the product and a combination of these areas. One example of examining our process is related to our In Vitro Research Tools (IVRT) business. We initially developed a process for attaching our Bio-Spun™ scaffolds onto plastic housing for what is called high-throughput screening (HTS). What this means is that you can run 24 or 96 individual tests at one time if you are looking to screen different drugs. This allows you to run a lot of tests in one shot. Our manufacturing engineer Kyle developed a great process that could be translated across many different types of plastic housings. Customers came to us and said that they would like to use individual tests as well as HTS. We were not sure how this part of the IVRT business would pan out so Kyle developed a process where we could make sufficient batches to prove the concept out. We are now getting more and more requests for this version of the plastic. I was working with the summer interns, showing them the process to make these inserts. We started to discuss how can we improve on the current process to make larger volumes. While I know our current manufacturing team can develop a modified process, it is great to have people early in their careers critically thinking about it and providing suggestions to the team.

Changing our equipment is something we’ve always done since inception of the company. Our very first electrospinning unit was made using a container I purchased from Sears Hardware, some Legos and an elastic band that I swiped from the kids and a rigged needle holder. This simple piece of equipment made some of our first devices. Obviously, we realized that to be successful, we couldn’t keep using this equipment. Purchasing an existing electrospinning unit was not a desire of ours (no offense to companies making such units) because there were too many bells and whistles which we believed would create issues later on if we were looking to get FDA approval for a device. We are still making our electrospinning units in-house. We’ve come a long way since then. The new unit is mostly automated, with software for the unit being developed in-house (thanks to Art Martin, our VP of Manufacturing) so we truly control the process. This unit has morphed into a manufacturing unit with plans for developing specific devices/scaffolds using it.

An example where both the process and equipment are currently being changed is for our Bio-Spun™ Cell Chamber. This device, and the materials that comprise it, are being assessed by many groups. While the electrospun materials are made using a semi-automated process, the chambers themselves are hand-made. Even though these are hand-made, these devices are made the same way each time as indicated by the consistent positive data we have developed internally as well as what we’ve received from external partners. With the amount of interest that these devices are gathering, we are already looking forward to developing processes and equipment that will make production of these devices more automated. This is a full-team process, from R&D through manufacturing. We are well aware that orders for this device could grow exponentially so we are looking to tackle this change head on. Some of the equipment for this process will be developed in-house and some will be customized using outside vendors.

Sometimes change is good (and needed for future success)!

Please check out our next one on July 29th. We’ll see you back here on August 5th.



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