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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

How to License or Sell Your Medical Device Intellectual Property

Part I – Presenting Your Idea

Anywhere during the product development cycle, it may make sense to discuss your medical device with potential acquirers. Licensing implies that you will still control the company that the technology was developed under and ONLY the intellectual property is transferred to the acquirer. A license can be exclusive (1 company) or non-exclusive (you can license the same idea to multiple companies, sometimes limited in number). When reading this article, you can replace “license” for “sell” if you plan to sell the entire company that owns the technology. The terms technology, device, idea, Intellectual Property (IP) are used interchangeably. They can mean a patent, an FDA clearance, a good working design, or just an idea.

Some projects are started with the intent to license or a plan to commercialize a device before licensing. As I mentioned in an earlier article, no matter what your end goal, the further you can take your idea in the development process (mitigating risk) the better return you should expect.

TIP: Always get an NDA in place before providing confidential information. For information on NDAs checkout the link below.

This 3-Part Series of short articles will cover, Presenting Your Idea, what to look for in a Term Sheet and finally, Things to Ask For in Your Licensing Agreement.

Want to get a company interested? Get your ducks in a row.

Often times, great ideas fail to be acquired because they are simply not presented well. To generate interest in your IP you need to demonstrate its credibility and value in a clear and concise manner. Here are the things you need to do:
1. Make a clinical case for your IP – Better surgical outcomes, saves time in surgery, user testimonials, etc.
2. Make a financial case for your IP – Lower cost, new market, etc.
3. At a minimum, have working prototypes – It is better to have production quality functional parts. Even better to have an FDA cleared device with multiple surgeries completed.
4. At a minimum, try to have provisional patents filed – It is better to have an issued patent with strong claims.
5. Address your regulatory path – A 510(k) cleared device will require a much smaller investment by the acquirer. Other clearance types like a PMA (PreMarket Approval) will require a larger investment and a longer time to market but can create an additional barrier to entry for competitors.
6. Understand the current reimbursement situation – With bundled payments and continued downward pressure on physician compensation it is important to address reimbursement if that information is known. If there are codes for the procedure or similar devices, know what they are. This matters to a company because without a code it will be harder to get user adoption. If the procedure falls outside of existing codes, new codes can be created but it is not easy to do.
7. Build a team of professionals – The team should be made up of professionals that lend credibility to the idea. They may have equity in the idea or be compensated hourly. They could be independent consultants, advisers, friends, colleagues or company representatives. Depending on your specific device you may want to cover the following areas: Physician, Engineer, Sales, Biologist, Manufacturing, Regulatory, Reimbursement, Patents. It is fine if you have an individual cover multiple areas. It is most important to have representation for areas that you are lacking in expertise.

This information can be compiled into a simple, short (6-7 slides) presentation (or animation) showing how your device functions. It will be similar to a pitch deck, but since raising capital is not the intent, the approach is less focused on the finances and more on the overall story.

The next step is to identify and begin discussions with target companies. There are multiple ways to do this, aside from a soft introduction, sometimes cold calling is the only way. Otherwise you can engage professionals to assist with getting in front of the decision makers.

TIPS FOR PRESENTING YOUR IP:

1. The best way you can sell the idea is to make it as easy as possible to incorporate it into existing product portfolios. It may be an improvement on an existing technology, a complementary device or a device that warrants a new technique. Be prepared to discuss specifics on why your device is a good fit for a particular company.

2. Technologies that require extensive surgeon training (such as new techniques or surgical approaches) are costly to implement and carry a lot of risk for a company. A large reward has certainly proven to be there for many of these types of technologies. Be prepared to explain why it will be worth the investment.

3. Companies don’t like change. Even if your idea is better than their current technology you may want to find a way to complement or improve upon their existing products first.

4. Unless it’s a perfect fit, the biggest company may not be the best company to approach.
Part II will cover what to look for in a Term Sheet. Thanks for reading. Please share with someone if you think this information will be helpful.

Lawrence Binder – Chairman – Binder Biomedical, Inc.
lbinder@bindermed.com www.bindermed.com

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.

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.