Surgeons note limitations of existing technologies and encourage innovation. They identify problems with the existing technologies and areas that require improvements. Surgeons and physicians have helped medical device companies develop implantable pacemakers and defibrillators, pulse oximetry, balloon-tipped catheters, surgical staplers, laparoscopic instruments, biological meshes and many other successful medical devices. Surgeons naturally understand medical device needs and design. Medical device consulting firms highly value their opinion and feedback for medical device business model creation. Surgeons obtain one-third of the medical device patents obtained by physicians in the US. 

Filing a Patent 

The innovation should answer the following three questions to meet patent criteria: 

  • Is it a novel technology?
  • Is it a useful invention? 
  • Is it a non-obvious invention?

If the innovation meets the patent criteria, the next step is “provisional patent application” with the United States Patent and Trademark Office. It includes an “enabling description”. 

Licensing the Patent 

The next step is attempting to “market the patent” to seek out companies for licensing. According to federal law, NIH recipients researchers can retain the patent’s ownership. However, researchers are encouraged to commercialize their patents to support the public interest. The technology transfer office sends a one-page non-confidential product description to companies interested in the invention. Most companies show interest in well-developed products with commercial potential. A prototype with promising initial data can secure a lucrative licensing agreement than a simple product sketch.   

Establishing a Start-up 

There is another option available to an innovator. The innovator can seek out angel investors and capital funding to establish a medical device start-up. In angle investment, an individual or a group typically provides between $5,000 and $500,000 to the start-up for ownership equity. A venture capital firm provides $100,000 to millions of dollars for ownership equity. A robust medical device business model can attract investment start-up requires to develop the novel surgical device. Medical device consulting firms also help medical device start-ups with medical device market research and analysis, medical device competitive analysis, medical device positioning analysis and a range of other consulting services to gather data to determine the commercial potential. The consulting firm also identifies key opinion leaders to get their insights. 

Regulations  

The medical device start-up has to determine the class of the medical device. The company has to follow all the FDA regulations according to the surgical medical device’s class. The company is also required to work with a consulting firm for regulatory compliance. 

Strategy Inc offers the following services: 

  • Voice of the customer analysis 
  • Medical device Market analysis 
  • Medical device value analysis 
  • Key opinion leader identification 
  • Risk analysis 
  • Competitive analysis 
  • Positioning analysis 
  • Financial valuation 
  • Exit strategy 
  • Business plan 
  • Portfolio analysis  

Descriptions: This article describes how to patent a novel innovation and turn it into a surgical medical device. The article also briefly describes how to commercialize a novel surgical device.  

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