Binder MED

Top 5 Mistakes Medical Device Inventors Make When They Have A New Idea

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:

  1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. 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

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.

Binder MED

7 Signs That You Need To Fire Your Outside Product Development Firm

So, you finally got your medical device project started but you just can’t seem to cross the finish line. From failing prototypes, failing mechanical tests, going over budget, to slipping timelines… your medical device development firm is failing you. If you are an OEM, you start to wonder why you didn’t do this project in-house to begin with. If you are an individual or small company maybe that wasn’t an option. Below are 7 signs that you need to cut ties with your outside development firm and find a new one.

  1. They don’t understand your vision. The key indicator here is that you spend too much time re-explaining things to the engineer. Whether that is the surgical technique, branding, or the ultimate cohesive functionality you need in the final system. Everything may have started out great in the beginning but projects can drift away from their original vision. Be ready to cut ties and move on to a development company that keeps your vision in focus throughout the entire project.
  2. The quality of the work output is poor. Product development is a process and not every design will work perfectly, especially in the beginning. How good is the firm at identifying and fixing problems? If they are responsive that makes a big difference. But having fewer problems is even better. While the owners or managers of many development firms may have medical device experience the actual work is often handed off to junior level engineers that may not. This results in a disconnect between the quality of work you are paying for and what you get in the end. Attention to detail is critical.
  3. There are no clear deliverables or they are not being met. I hear on a regular basis from new clients that deliverables are either completely ignored or never clearly defined at the beginning of a project. A clearly defined scope of deliverables keeps everyone on target and the development team accountable.
  4. They are not available to meet during the times you need. This one I see as more of an issue for the individual inventor. But we all know that the operating room is not 9-5 and surgical schedules can be unpredictable. The need to be flexible with meeting times is the only way to keep projects on track. An engineer should be available in the evening and on weekends – 24/7. Meetings should utilize technology such as web-based screen sharing and video conferencing. Your time is valuable and a partner respects that time.
  5. They did not help you budget for the entire project. Too many times most of the project budget is used up in the beginning on patenting and prototypes. By the time you make it to the final development phases funds are starting to dry up or are no longer available. The project starts to stall and there are little repercussions for the firm. Don’t let the firm drag the project out. It is better to move on and engage a firm with better planning and a financial strategy to see it though its final phases.
  6. They are not willing to take an equity position in the project for reduced fees. The best thing you can do is align the interest of both parties to make the project successful. Many companies are not able to reduce their fees due to large overhead costs. If you like the idea of reducing fees, look for a small to mid-size firm with low overhead that can provide flexible fee arrangements.
  7. They have trouble getting manufacturing quotes and acceptable lead times. With our booming economy it is not unheard of for manufacturers to quote 16-18 weeks for production lead times. Or for them to no-quote “small” jobs. You want a partner that has strategic relationships that can deliver prototypes and production quantities in more reasonable lead times of 4-12 weeks.

There are certainly other areas that an outside firm can let you down such as poor quality documentation or over-billing but I felt this list was enough to make my point. Sometimes you have to know when to move on.

Lawrence Binder – Chairman – Binder Biomedical, Inc –

This information is for reference only and not to be considered legal advice. We recommend that you work with an attorney when making important legal decisions.