Week 7 – Technology Appreciation – An Insider’s Perspective

Hope all is going well.  This month has been a real smorgasbord across the company, from trying to finalize agreements or path forward plan that seem to have taken forever to bring in for a landing and producing materials that will hopefully be used in next-generation medical devices to testing our new cell chamber devices that we are developing for Gates Foundation and working on raising capital to expand our manufacturing capabilities.  Not that we don’t have a ton of things going on all the time across the company, but this month really was especially challenging since the areas we were tackling were across the board.  Makes it hard in terms of transitioning your thought process as you are going from fund raising strategies and discussions with potential investors to implantation studies.  I am sure, based on many blogs that I’ve written that you can make a very good guess as to which one of those things are my favorite.

Research and development, while not perfect by any stretch of the imagination, is still my preferred choice.  Failure happens a majority of the time so you have to have the right mind-set to be a researcher.  I love the thrill of trying to tackle a problem, both individually and when our team is working together to do so.  It can be frustrating when something doesn’t work out, but as well always say, that’s research.  If it worked perfectly each time, that’s manufacturing.  Not to sell manufacturing short because sometimes things don’t work out, but the system is build for traceability which helps on the troubleshooting side.  The goal for our company is to develop a material or device with the research team and then transfer that material/device into manufacturing so that it will be made the same way each time.  It has to be or else there can be problems for the product.  We don’t think about that in our everyday life, whether a medical device or even something simple as your kitchen faucet or flying on an airplane.  We take for granted that what we purchase will work perfectly.  We don’t see the amount of testing that is done to make sure that this product works the same way, every time until it’s work-life expires. 

Establishing manufacturing in BioSurfaces, which is an ongoing process that will continue to evolve over time throughout time, has really allowed me to see both ends of the spectrum, from the researchers who want to make these intricate devices and the manufacturing team asking how will these be made the same way each and every time.  We are fortunate to have both processes under one roof and that our teams crosstalk so that there are no surprises as a product is in its infancy stages.  It allows the manufacturing team to see what is coming and put their input into the material or the device so that the overall process in making a product can be smoother.  I remember one prototype we were thinking about for our fistula plug, which was suggested by a surgeon collaborator, was stringing together a lot of individual parts onto one unit for each plug.  While from a technical standpoint it was an excellent idea, my first thought was how would this be manufactured.  It was not practical from an engineering and production process.  We used this input to create something close to this design but without the intricate design. 

As many of you are aware, we are making great progress on our Bio-Spun™ Cell Chamber, specifically for our Gates Foundation program.  This cell chamber is being used to enclose and protect genetically-modified cells that produce a target antibody, in this case is anti-HIV.  Our goal is to implant this device into patients in low and middle income countries who cannot afford the cost of existing drugs but need long-term care.  Our device would serve as a biofactory, allowing the body’s nutrients to feed the cells, the chamber protecting the cells from immune attack and the cells producing a therapeutic level of the antibody.  Benchtop studies have looked really good and now we head to preclinical studies.  Our manufacturing groups is aware of the design so should these studies work, it will not be a lot to transition this device over for large-scale production.  I was able to go back to my roots and assist our excellent surgeon collaborator in implanting these devices.  As I mentioned, there are so many things we take for granted; the anesthesia administration process (device and anesthesia), the suture, syringes, needles and of course the cell chamber all working the right way.  It truly is amazing when you think about all that goes into the process.  We are excited to see how the study comes out.  We know we’ve planned as much as we could and now it’s up to the gathering the data to see how it truly goes.

Seeing this over the past two weeks reminded me of the things I take for granted.  But life has a way of reminding you.  Yesterday, I went in for elective arthroscopic surgery on my knee to clean out some bone fragments.  I think of all the things that need to go right (the IV catheters, anesthesia, monitoring equipment, arthroscope, surgical tools) to make this “routine.”  This is not to take away from the outstanding nurses, anesthesiologist and surgeon that always have to plan for those not routine issues that could come up.  Sadly, I know too much about what can go wrong so your mind can go down a lot of different paths.  It did not dissuade me at all from getting it done.  I am fortunate that my procedure seemed to be routine and recovery is underway.  As I think about how we are working to bring our devices or materials one day to patients, I will always keep in mind that there will be a nervous person like me hoping that all goes well and that it truly is routine. 

We look forward to having more updates on all areas we are working on next month.  To all of our US readers, I would like to wish you a very happy Labor Day holiday!

Matt