Week 13 – Small Victories

July 26, 2019

In medical device development (and science-related fields in general such as drug development and discovering how a disease like Alzheimer’s forms/progresses), small victories are a way of life.  Get enough of them on the same program and maybe this leads to something promising.  Sometimes, the small victories are just that and may not advance the cause at all.  I equate it to fighting a war in that if enough small battles are won, you try to advance so that at one point the war can be won.  There is no better example of this than drug discovery.  Only 1 in 5,000 drug candidates that make it through to clinical trials become an approved drug that helps a patient.  This is on top of the fact that hundreds of thousands of potential drug candidates are screened to get to these 5,000 to get to the one that works.  For the single drug that works, it costs almost $2 billion to get it to the point that it is ready for human use.  I am not advocating that this is why drug prices are so high.  It is merely to point out that there have to be a lot of small victories along the way in order to achieve success.  Medical device development is no different.        

 

This type of “combat” is not really a known commodity to people entering the field.  I know I didn’t have a clue so it was a rude awakening.  It would be like working at a coffee shop and a majority of the time, the coffee maker is broken or is malfunctioning.  I impart this “wisdom” onto our high school and college interns (and remind our permanent folks about this too) that a majority of their time will not be successful.  You may be thinking that I am a very pessimistic person, which if you know me, could not be further from the truth.  The reason I let these young people know this is that while it can be a grind, they need to appreciate the small victories when they happen.  Unlike a lot of jobs where you get instant gratification, you may go for periods of time with little to show for it.  If you understand this going into it, it makes success all that much sweeter.

This week saw several small victories in different areas that we are working in.  Nothing makes me happier than to see the smile on their faces when their experiment, equipment development, graft production and graft implantation goes well.  I know that feeling well because I’ve lived it (unlike many CEOs who may not have been a scientist).  Let’s start with an update on our NuSpun Vascular Graft.  We were excited to see that our first 4 grafts are patent (blood continues flowing through them with no blockage) at 45 days.  The other 3 grafts are also all patent at earlier time periods.  Time will tell how things progress but we are excited about this data.  This week we also saw our manufacturing group begin to initiate extensive testing on our manufacturing unit and develop test equipment that will provide us a process to accurately detect how much fluid (blood) will pass through the walls of graft.   Lastly, we continue to make steady progress with preparations in terms of regulatory and quality management system documentation.  These areas are essential as we look to bring the graft forward through to patients.  Every step needs to be documented and traceable.  

 

We also continue to develop and evaluate different devices/materials.  We continue to work on a material that would prevent bacteria from growing onto it using our drug-delivery technology.  Our high school interns developed a process for detecting a single antibiotic in a mixture of two antibiotics.  This required many iterations and some failure before seeing some success.  We evaluated the ability of how this antibiotic-loaded material would kill bacteria after being subjected to extensive washing (mimicking body fluid interaction).  A clear “halo” around the material shows a killing zone that is created by the antibiotic releasing from the material over a 2 day period (see picture).  We also continue to refine and prepare devices for Takeda that are being evaluated in preclinical testing.  These devices, if successful, would provide an alternative to patients afflicted with complications associated with gastrointestinal disease or may be able to deliver a drug into the patient without injections or pills (future blog alert).           

 

Quite a few smiles at BioSurfaces this week!  Nice to see the team savoring the small victories.  Brings a smile to my face!

 

Have a great weekend! 

 

 

Matt          

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