The firm’s business model includes the identification, screening, and evaluation of inventions. When the StepWise team decides to develop an invention, the firm will form a company around the invention and will arrange funding to develop the product. The screening and evaluation process is multifaceted, and includes: the assessment of the market need, a forecast of the size of the market, determination of the regulatory path required for clearance, the requirements for both preclinical and clinical studies, the availability of intellectual property protection, the cost of manufacturing the device, evaluation of the competitive landscape, and, finally, the presence and interest of suitable acquirers.
The StepWise Medical approach will reduce the overall risk of product failure by streamlining the development process, resulting in the cost-effective development of products that become candidates for acquisition to medical device companies. The firm will provide the expertise necessary to select the best of these early-stage technologies, where the potential rewards outweigh the risks involved in their development.
The firm expects to generate attractive returns on invested capital by selecting commercially appealing, high-impact products. The de-risking of the product development process will ensure healthy returns to investors. StepWise Medical is targeting inventions that require an investment of up to $5 million, from identification through development, and that can become targets for acquisition within 24 to 36 months.
StepWise Medical has already screened over 100 novel product concepts and has created a pipeline of several attractive products. One product has been spun out into a standalone company: Visant Medical, Inc.
Visant Medical is developing an innovative product to address dry eye syndrome. There are an estimated 30 million dry eye sufferers in the US alone, and only one million or so are finding relief from prescription drug treatment or over-the-counter eyedrops, so there is a significant opportunity to provide a device-based treatment to these underserved patients. The product, a proprietary kit, contains an occlusive material to block patients’ tear ducts. This unique material has several positive attributes:
- It preserves a patient’s natural tears
- It prolongs the effects of eye lubricants
- It provides a convenient medium for drug delivery
Product development at Visant Medical has already been substantially de-risked. The occlusive material that is used in the product is a well-known and approved biomaterial, and the material has already been successfully tested in more than 70 patients in the US. The company’s intellectual property is protected by two issued US patents. The Company is currently in financing discussions.
With Visant Medical successfully spun out of StepWise Medical, the firm is continuing to search for additional new inventions.