I hope everyone had a safe and relaxing holiday weekend. While we are fortunate to be afforded this time off, we are forever cognizant and grateful for the people who have given the ultimate sacrifice for our country so we can remain a free society. As the saying goes, freedom is not free and we should never forget that. It is always nice to get some time away, even if it is for a short period of time, to recharge your battery. It is hard to be fully effective without some form of a break.
That being said, some of the better ideas that I have had during my over 29 years in this field have come during or right after some down time. For the entrepreneur, this time allows you to focus on areas that maybe you haven’t had time to reflect on, re-evaluate current programs and think about results from recent experiments to determine what’s next. This long weekend was no exception. I was able to think about some changes to our ongoing preclinical study (Takeda), develop an idea for targeted electrospinning of a drug for our access graft (KidneyX), continue to plan for preclinical assessment of our vascular access graft, formulate a high-level plan for future business and plan for upcoming development studies for Edwards, National Institutes of Health (NIH) and MatTek. Even though it was a shortened week, we were able to make progress in all of these areas. Over the next weeks and months, we will look to provide an overview of progress in these areas, especially on devices being internally development since we have more latitude to share information.
To provide some insight into who we are in terms of our business model, BioSurfaces has two main pathways it is actively pursuing: 1) advance our internally-developed technology (i.e. vascular graft) and 2) work with partners/customers looking to utilize our technology for their applications. Both pathways, while starting at different points, all lead to establishing a manufacturing process for a proposed device. While I thoroughly enjoy talking about all of the research and development (R&D) going on within the company (an area near and dear to my heart), I am also equally excited about the potential for bringing manufacturing into the company. It is sad to me that a lot of companies ship device manufacturing overseas. There would be no better feeling than to manufacture devices right here in the US.
Getting to this point will require us to execute on several key areas such as implementation of an electronic quality management system (at a very high-level, this system is used to track a device at all areas along the manufacturing process right back to the raw materials), development of a GMP-compliant electrospinning unit (making an electrospinning unit in which the software is validated so that a select device will be made the same way each time, every time), and setting up a cleanroom to produce a device (this room will significantly reduce any potential contamination of a device from dust and particulates). Executing these objectives will provide us a significant strategic advantage as we move the company forward. We are so proud of our manufacturing team and what they have accomplished in such a short period of time in all of these areas. To be able to convert what has been developed at the R&D level to a manufacturing process for a device is truly mind blowing. A case in point is our access graft. We are already underway with electrospinning an access graft on our GMP electrospinning unit. Making different components for this unit more user friendly as compared to R&D shows the vision of this group. So very excited to see what is next!
The upcoming week will focus on expanding our preclinical studies, advancing discussions with potential investors/strategic partners, continued evaluation of our GMP electrospinning unit by making grafts, development of new equipment for the manufacturing/testing processes and working on our current programs.
Don’t forget to tell a friend or co-worker about following us on social media. We would love to expand our audience and you can help make that happen. You can link to all of our social media sites with a click of the button. Locate Facebook, Twitter and Instagram icons right on our website on the footer of each page. We will begin to provide more breaking news and quick updates over the upcoming months.
Have a great weekend!