The development cycle for a new medical device is extremely taxing on its OEM; there are many questions which the OEM must ask themselves before delving into the lengthy process from research and development to having a marketable product.
Some important examples are: Is the medical device using any new technology? Are there third parties who are already marketing a similar product? Do they hold a patent on the device technology? If yes, when will it expire?
To understand the importance of medical patent filing and how challenging applications may be, we should look at some statistics first.
In 2017, out of all the patents filed in the US, the EU, China, and a few other prominent regions combined, the medical technology category had the most applications received for patent approval, and the number is only growing each year. Just in 2017 there was a 6.3% increase in medical patents filed when compared to the year before, and the trend only seems to be continuing.
So why are companies so concerned about filing patents on their new products?
Medical research and development is a very demanding process. On average, it takes 10-15 years and $1.6 billion to apply and complete all the necessary trials to prove the safety and effectiveness of a new technology or pharmaceutical, which is a huge investment for any organization.
Along with high development costs, the need for patent application and later FDA approval results in an even longer lead time to market. For the device to be able to reach its market, OEMs also have to ensure it is high quality and performs perfectly. With all of these barriers, there must be sufficient incentives for the private sector to provide the funding needed to advance current medical technology. Without proper intellectual property protection at the fruition of years of hard work and investments, any other company could easily copy their research results and put out a competitive device without putting in any of the upfront work or funding.
Patents complete a circle of supporting the researchers and investors for sacrificing years and millions if not billions of dollars. They allow the companies to recoup what they’ve spent during the long R & D process while the patent is active, so they can re-invest the profit that comes from keeping their new technology exclusive. Essentially, patent protection makes developing new technologies attractive for investors, possible for researchers, and moves the industry forward.
What does Sanbor Medical, as a contract manufacturer, do to give your medical intellectual property the maximum protection?
- Sanbor Medical owns its offshore factory. All of the production work is done by our own employees, who have signed a confidentiality and non-compete statement. We do not contract out orders to uncontrolled factories.
- All product documentation from clients is reviewed and then made anonymous by our US project management engineers before being sent to the factory. All identifiers such as name or address are removed and the project itself will be code named.
- Clients place orders with Sanbor Medical’s HQ office in Allentown, PA. We then act as a secondary barrier and place the order with our factory.
- No single employee has full access to all documents at the factory.
- Sanbor Medical is a U.S. company, thus providing legal recourse should any problem arise.
- In the 20+ years since the factory was incorporated and wholly owned and operated from the U.S. since 1993, we have never had an IP incident.
- IP protection laws are catching up with technology and inventions and becoming stricter.
With our impeccable record with keeping our customers’ intellectual property confidential, Sanbor Medical is a great choice to trust your new product with. We are always thrilled at the opportunity to work with new designs. April 26th is World Intellectual Property Day, we hope you celebrate it by choosing a reliable strategic partner like us!