Developing a Medical Device Start-up
During medical school, I started a medical device start-up company along with 2 other co-founders. I wanted to share parts of our story below in order to help guide other aspiring entrepreneurs in their journey. Below is an abbreviated version of what we did over the past few years and all of the resources we used to help us get started. If you are a female founder in the Boston area, I would also highly recommend applying to the Capital Networks Female Founder Award. Being part of the Spring 2020 cohort was an incredible and inspiring experience that helped me grow so much as a businesswoman and as a person. Since winning the award I have been contacted by investors and incubators interested in my business.
Why we started Thistle Medical Technologies:
Cornea disease is the third largest cause of blindness in the world, affecting over 20 million people. Patients with severe cornea disease or damage must undergo corneal transplantation in order to save their vision. An estimated 13 million patients worldwide need a cornea transplant, with only 1 cornea available for every 70 needed. In the midst of such a tremendous need for cornea tissue, an alarmingly high rate of corneas are discarded after they are surgically recovered from a cadaver. With the current instruments available for cadaveric cornea recoveries, technicians often misplace essential incisions and over manipulate the delicate cornea, rendering the important graft unusable. The OcuScope, a one-time use, sterilizable device, was designed to improve the cornea recovery process by increasing technician precision and accuracy. With the OcuScope as the inaugural device, the authors chose for their capstone project to co-found Thistle Medical Technologies, a medical device company. Together, the founding team: formed a limited liability company, designed a website and marketing materials, went through iterative revision of the device, and sourced manufacturing, sterilization, packaging, and distribution services. All of these steps brought the device to the point of small-scale production.
Patent Process
The patent process was completed before the initiation of this capstone project. The Patent It Yourself book by David Pressman and David Blau was instrumental in providing a useful overview on evaluating patentability and how to prepare and file a patent. Patenting the OcuScope device started with an informal patent search to investigate if the idea was already established. Patent search engines and databases such as Google Patents and the United States Patent and Trademark Office (USPTO) patent database were useful to quickly gauge the scope of intellectual property related to the device. When no obvious competing patents were discovered, a professional patent search group was consulted to perform a thorough investigation of existing intellectual property related to the device. With the results of the formal patent search, it was determined that it was worthwhile to pursue a utility patent for the device. Initially, a provisional patent application was submitted to the USPTO and was accepted in January 2016. The application established that a utility patent was in the process of being prepared and submitted. Once the beta device was designed a patent attorney was consulted to help write the final utility patent application, which was submitted in April 2016. The patent was initially rejected in November 2017, and was subsequently modified and re-submitted. One year after the initial patent rejection, in December 2018, the utility patent was granted.
Business
The company was officially founded on September 9, 2019, with three founding members. The team decided on Thistle Medical Technologies as the company name after surveying family and friends. After the company name was established, the team decided on the following as the company’s mission statement: “Our mission is to improve the current tissue recovery practices and by extension, improve the lives of patients’ in need of tissue transplantation. We are committed to developing innovative instruments for tissue banks so their recovery technicians can recover high-quality tissue that surgeons and their patients deserve.” The initial goal of the company was to market the patented OcuScope device, in order to improve the cornea recovery process with the hope of additional devices to follow.
An executive summary was written using a website called “LivePlan” to help guide and format the process. The executive summary included the following: the problems, the solution, the initial market, likely competitors, and future expectations. The business plan was also filtered down to a one-page summary to provide to potential investors or clients.
The company was then registered as a Limited Liability Company (LLC). The decision to become an LLC, rather than to Incorporate, was made as it was unlikely investors would be needed given the company’s low start-up costs, projected profit margin, and limited regulatory burden. Lastly, the Trademark Electronic Search System (TESS) was utilized through the USPTO to determine an appropriate trademark for the device. The OcuScope trademark was filed with the USPTO in September 2019.
Resources such as The Startup Owner’s Manual by Steve Blank and Rob Dorf, along with the How to Start a Startup Stanford video series provided useful information on how to navigate as an early startup.
Branding and Marketing
Branding the company started with the name and declaration of the mission statement and continued with developing the company logo and building a website. The company logo was designed using Adobe Illustrator CS6. The logo was designed as an abstract version of the top-down view of the OcuScope. The website name was registered and hosted through Bluehost and built using WordPress. Text for the website was adapted from the company’s executive summary. Additional marketing materials such as a leave-behind card and business cards were designed to help the business communicate with potential clients. A leave-behind card is a valuable tool used to help an individual e.g. client, supervisor, or interviewer remember a company or individual. In order to communicate information about the company to potential business partners, a pitch deck was developed. The original pitch deck was developed using the Ultimate Business PowerPoint Template purchased from improvepresentation.com.
Funding
When starting a startup there are many sources of funding to consider, the needs of Thistle Medical Technologies fell within the scope of Type 1 Funding: Self-Funding; the company also pursued Type 4 Funding: Collateral Free Funding through the submission of two separate grants. Thistle Medical Technologies submitted a grant to the Protolabs Cool Idea Award, a manufacturing grant for up to $100,000. The OcuScope was selected as a finalist for the grant. The second grant submission was to the Catalyst Fund which provides grants to early-stage startups that address a global challenge; this grant went unfunded.
In addition, the company considered Type 2 Funding: Equity-Based Funding. The female member of the founding team was selected for the Capital Networks Female Founder Award. The Female Founder Fellowship provided opportunities for female founders to attend workshops and events focusing on garnering funding from Angel Investors and Venture Capitalists. The company was pitched to several Angel Investors as practice for future investment opportunities. Additionally, Thistle Medical Technologies was contacted by an incubator that offered upfront funding to the company in exchange for equity. The decision was made to maintain full ownership of the company and continue with Type 1 Funding.
Production
Selecting a manufacturing company as a start-up can be difficult. Sterling Technologies was the first company that was contacted. While Sterling Technologies was amenable to working with startups the account manager there recommended that initial production be done with a prototyping company, such as Protolabs, to keep the costs down. Protolabs was a small batch production company that specifically developed and produced small batch plastic and metal goods. Working with Protolabs allowed for the continued modification of the prototype.
One of the great things about Protolabs is that if you have an incredible novel idea you can apply for the Cool Idea Award. The Cool Idea Award is a manufacturing grant that can be used for Protolabs’ injection molding, 3D printing, CNC machining, and sheet metal fabrication services; the grant total is determined by Protolabs on a project-to-project basis.
Onshape, an online computer-assisted design (CAD) development platform, was used to create and refine the device 3D model. The initial prototypes were made via 3D printing. 3D printing services such as Shapeways and Protolabs allowed for simple experimentation with the device design which was useful for iterative development. After the prototype was finalized it was decided that injection molding would be the best manufacturing process to mass-produce the device. Injection molding is a manufacturing process where molten plastic is injected into a mold, which is then cooled and removed from the mold to produce the desired device. Injection mold design is an intricate process, so we utilized UpWork, an online freelancing platform, to consult a mechanical engineer skilled in injection mold design. With the injection mold design finalized, Protolabs was selected to create the injection mold. There were many different plastic material options to inject into a mold. Given that the OcuScope device was to be used on potential transplantable tissue, a U.S. Pharmacopeia (USP) Grade VI plastic was chosen which was certified to have no harmful reaction or long-term effects when in contact with the body.