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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 lbinder@bindermed.com 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.

Binder MED

Confidentiality Agreements and Your Medical Device Idea (Free Template)

How can you protect your idea? I regularly advise clients on the importance of protecting your new medical device ideas and how that relates to your investment in developing them. My general recommendation is protecting your idea as a 2-tiered approach. First, establishing Confidentiality with anyone you share your idea with and Second, pursuing patents. The focus of this article will be on Confidentiality (CDA, NDA, etc.).

You may have an idea that you feel is not patentable or you may not want to expend the cost of patents right away. However, below are just a handful of reasons you will still want to establish Confidentiality.

During Early or Pre-Development

  • You could be first to market with an idea
  • Your idea involves trade secrets
  • You are still developing the final solution
  • You don’t want competitors to know what you are doing
  • You need time to perform market research
  • You are raising funds to develop the idea
  • The engineering firm you hire may come up with a patentable solution

Later in the Development Cycle

  • Early user feedback
  • Results of Market Research
  • Preliminary Mechanical / Biomechanical Testing Data
  • Animal Study Results
  • Proprietary Manufacturing Techniques and Processes

Confidentiality Agreements and Patents. Inventors only have one year from Publicly disclosing an invention and related information to filing a patent. The logic here is that patents need to be novel and public ideas that are more than twelve months old are no longer considered novel to the US Patent Office. In some countries you will lose patentability immediately upon Public disclosure and disclosure can be via written OR oral communication. So if you don’t think there is anything to patent (there may be) or you are not ready to file a provisional now, this further emphasizes the need to engage in a Confidentiality Agreement. This will establish the disclosures to be private, NOT Public.

The Anatomy of a Basic Confidentiality Agreement. Whether it is a CDA, NDA, MNDA, or Non-Use Agreement… I have seen them more than ten pages long, be generally biased to one party, and be overly complicated. Below is a diagram of the current Agreement that I put together and use regularly. It is a single-page Mutual Agreement of Confidentiality and Non-Use. There are certainly more comprehensive (longer) Agreements available online or from your attorney but this one is easy for me to explain and I feel it protects both parties relatively well. No matter what, you need to consider any Agreement only as a deterrent for the other party. It is similar to a patent in the sense that you will be responsible to enforce the terms of the Agreement. So, if you don’t generally trust someone (or entity), you are probably best not to disclose anything, whether you enter an Agreement or not.

TIP: Just because you get an Agreement in place, still only disclose information necessary to communicate the idea effectively and nothing more. If you have filed a patent, share the filing number to confirm that it has been filed, unless there is a licensing offer on the table avoid sharing the actual claims or patent drawings.

A few important points in this Agreement:

  • It is a Mutual Agreement. Both parties can be Disclosers and Recipients of information. Companies may want to share confidential sales info or future development strategies with you and this allows them that flexibility.
  • The Disclosure period is defined as three years from the Effective Date but covers information disclosed two months prior to the Effective Date.

The information disclosed during the Term must be kept confidential indefinitely. Many Agreements only ask for Disclosures to be kept confidential during the Term.
Binder MED
If you would like a high-resolution PDF of this Agreement message me, ask for it in comments or provide your email and I will send you a copy. Disclaimer: I am not an attorney so feel free to have it reviewed by yours before using.

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

lbinder@bindermed.com www.bindermed.com

This information is for reference only and not to be considered legal advice. We recommend that you work with one of our partner attorneys 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 – www.bindermed.com

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.