As a design and development company focused on solving mechanical design problems related to the development of medical devices for manufacturers and startups alike, and in business for over 16 years, we have built a team from the ground up working closely with clinical inventors and medical device companies to make our mark on improving the healthcare industry and to develop devices to prolong and improve our lives. Although Zewski has a record for delivering finished devices in both medical and commercial markets, as well as for providing specialized services, our unique skill-set has been solving specific problems our medical clients are faced with during the development of new technology.
Located in Houston Texas, home of the world’s largest medical center (TMC), our company has formed relationships with clinicians throughout the country, in no small part due to Zewski’s long term partnership with client Neotech Products LLC, a company specializing in neonatal healthcare devices. In our work, it has become all too obvious that one common challenge for clinical inventors is a lack of funding - and for us, a challenge was that we were only in the mechanical realm. Although the business was built from referral to referral and is still growing in that way, the funding issue was always a development barrier, and the electro-mechanical issue was always a technological barrier.
To overcome these challenges, in 2018 Zewski Corp. formed a co-op alliance with Umbach Consulting Group, an industrial design management firm, and Cooper Consulting Services, an electrical engineering firm in Friendswood, Texas, specializing in Class II and III medical devices. In addition, with remarkable timing, after developing a pericardium access device, PeriPortTM , for the late entrepreneur Jim Meador and Dr. Stephen Igo, M.D., I was invited to Pumps & Pipes 13 and the Houston Methodist Research Institute by Dr. Nicole Pardo, M.D. This introduction to the ongoing efforts of the Texas Medical Center to make innovation a key focus led me to wonder what other avenues were out there for innovators. I learned that many facilities were adding research and innovation to their care services. One such example of this is Rice University and the City of Houston's development of the ION Center. As a response, I decided to reach out to other hospitals, research groups, and universities to try and learn more about the opportunities at these facilities to help clinicians innovate.
I discovered that not only are these hospitals making a shift to innovation, like Seattle Children's, Akron's Children's and the well known Mayo Clinic, to name just a few, but many of them will partner with the clinicians to bring a product to market. In addition, accelerator groups like non-profit TMCx, and Health Wildcatters, will work with startups on the business and regulatory aspects of starting a medical device company and connect innovators to venture groups. As we looked deeper into this innovation phenomenon, we also discovered private non-profits like the Mayo Clinic and Bill and Melinda Gates Foundation, and government agencies like SBIR who also provide funding grants, with nearly no strings attached.
There are literally resources everywhere. Besides the business and clinical support, nearly every department of government health services has grants available for medical device funding, not to mention all of the private grants available. It is exciting to see funding circles begging innovators to submit ideas, incubators that help inventors understand the inner-workings of starting a medical device company, and large companies and hospitals wanting to offer clinical support. In fact, even educational institutions will offer up intern and senior students to help with product ideas. However, with all that, I also discovered that there is a big gap in this process.
Of the dozen or so hospital research centers, incubators, or innovators I spoke with, I was told they all lack access to those with experience in the development of quick turnaround proof-of-concept work, advanced validation samples, and production designs. The research hospitals are primarily involved in researching the biological effects of product concepts. The incubators are primarily involved in the business side of the start-up. The schools are interested in getting their students' feet wet in design. Short of hiring a full-blown design and contract manufacturing firm to take over the project, there seems to be little availability to contract the services to fill these gaps that are necessary to move the idea from paper to the point of clinical readiness.
Our core belief at Zewski Corp. is "the success of the company is not only about money but the journey”, and primarily our objective is to “contribute while connecting people and resources.” Imagine a design firm connecting clinical inventors to resources for funding, then helping them develop the technology, all while helping them form relationships with the incubators and hospitals that will help them get clinical trials done, ideally in hospitals that value research. This is the full-circle vision we have come to make our mission at Zewski.
Development companies like Zewski Corp. are the missing link because most design firms are waiting for the “funded” client to come to them and they want the whole enchilada. The problem is, most of the clients don’t even know what they are looking for or how to get funding. Therefore, our objective has become to take the solution to the inventors, to fill the gaps needed to align them with the resources they need, guide them through the process to get funding, and help them prepare a proper design for manufacture or clinical support.
Zewski Corp. is already involved in grant-funded projects in which the cost to the inventors and established companies can be minimal. After making several trips to Seattle, Zewski has connected key staff from the Seattle medical research community with those in the Houston medical research community. The Zewski staff regularly attend events at the accelerator TMCx and have meetings with technology vendors with the goals of: finding new tools to give inventors and clients, being available to the startups at the accelerator or those who have been recently awarded grants, and offering expertise to those stuck in the conceptual phase who don’t have the design and manufacturing expertise to move to a clinical-ready product. And we are just getting started because later this year Zewski will be traveling to several other research centers, hospitals, and component vendors of medical products in the northwest, east and midwest, to expand the connections in hopes of making more grant and technology opportunities available to the clients.
With 200 years of combined product design experience at our fingertips, Zewski Corporation is suited well to help clinical inventors navigate this process. Although we have to charge for design services (not funded by grants) provided by our highly-trained engineers, we believe the resources to which we can connect our clients offer valuable guidance for the projects at a limited cost to inventors.
Let us know if we can help you with a project or a question you have about developing your company's device ideas