By Lawrence Binder/Chairman at Binder Biomedical, Inc.
(linkedin.com)–The hardest part of developing a new idea is getting started. But getting started without considering this list could cause major project setbacks. Contact me to discuss how I can help navigate the complicated product development cycle and bring your new idea to life. List Below:
- Hiring an engineer or firm without medical device experience. The nuances of medical devices and specific surgical requirements take years of experience to understand. Anatomy restrictions and clinical requirements that a surgeon may take for granted are not always intuitive to engineers that are not familiar with medical devices.
- Assume that your idea will be acquired based on a sketch. Although this is possible, it is not very likely. Companies must mitigate many risks when acquiring new technology. Functionality, manufacturability, a clear regulatory path, and market reception are some of the risks that you can mitigate by taking your design further along in the development process. Companies are usually willing to pay more for YOU taking that risk. This is the reason Apple buys 7-10 companies a year.
- Spending too much on a patent before you have a working prototype. The development process needs to go hand-in-hand with patents. If you have only addressed a problem but have not identified and fully defined how to (and how others may) solve it then you are wasting money on a patent.
- Trust that companies will not try to replicate your idea. In the past if you had an idea written down with a date, that could protect your invention since your were the “first to invent” something. The USA patent system is now based on “first to file” for patent applications filed on or after March 16, 2013. Protect your idea BEFORE you present it to anyone. This means getting a non-disclosure agreement in place as well as only disclosing the information necessary to convey the basics of your idea. Although patents eventually become public information, it is not recommended to openly share provisional patents and specific claims with potential competitors.
- Patenting a technique or an instrument only. The problem with patenting a technique without a related device is that to enforce this patent, device companies would have to file lawsuits against surgeons for infringing on the technique. That is not good for business in general. The problem with patenting an instrument only (without a related device) is that most instruments are not sold to hospitals. When trying to enforce a patent infringement case the plaintiff will need to prove damages and may have difficulty determining the specific damage caused by the infringement since very few may have ever been sold. The exception here is disposable instruments.
Please share this list with anyone you think would find it helpful.
Binder Biomedical, Inc. is a full service product development firm with specific expertise in developing orthopedic / spinal implants and complete instrument systems. We can take a project from a sketch to commercialization and everywhere in between. We often partner with companies and individuals to offset development fees.
Contact me for more information about how I can help with your medical device product development needs. – Lawrence Binder [email protected] www.bindermed.com
This information is for reference only and not to be considered legal advice. We recommend that you work with our patent attorney or your own when making important legal decisions.
Great insightful info.
A great list. It is also important to realize that you do not have to disclose HOW you have done something, it is more important to disclose what it is that you can achieve / have been able to demonstrate, i.e. what is the clinical / economic problem that you have solved. Only “open the kimono” when real interest has been demonstrated.