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Intro to Medical Device Development

December 22, 2017

 

This brief document is from my own experience, much of which came from my experience as a physician inventor, and as chief medical officer of a medical device incubator called MR1 Holdings. I am no longer involved with them, but you can connect with them if you want. www.MR1Holdings.com

 

I have been involved in the successful development of two products-a wound irrigation device that was sold to Centurion Medical Products and a breast pump accessory light called Lactalite that I am manufacturing and selling myself online.  I have also been involved in the development process of numerous other products that have not been successful or are still in development. 

 

Intro 

Developing a new medical device is a complex, long, and potentially expensive process. From personal experience, if you are able to find or form a team that has a diverse skill set in the areas of business and legal matters, manufacturing, and design, you may be better off. If you want to do it alone, it is surely possible, but be prepared for bumps in the road. Have a dedicated folder in your computer and keep track of the steps along the way. 

I'm an ED doc and I've been through this process a few times now. Buckle up and good luck with your idea!

 

IP ownership

Most physicians, myself included, thought that since I came up with it, it's my idea. As more and more of us are becoming hospital employees, you need to be aware of intellectual property clauses that lay claim to IP. If you are at an academic center, pay very close attention to this issue. The great news here is that many of the physician owned groups such as yours are actually PRO-physician, and we send kudos to your management team for acknowledging this! Regardless, always make sure early on that you own it. Some administrators may not be aware that the language is even in the contract. It may just take a simple letter or phone call to let them know what you are doing and to seek formal written permission. Definitely better to ask first and not ask for forgiveness later. If you have any questions, an experienced healthcare contract attorney would be able to help you. Just like the medical chart, if it's not written down, it didn't happen. Have a signed release letter and keep it in your records. 

 

Being realistic 

I now want to cool the breaks and have a reality check. The likelihood of your concept making it all the way to the end is far less than 100%. It just is. Be prepared for setbacks, rejections, and lots of "no." That's ok. Same as getting into medical school, it sometimes takes a while. The second thing to know is that the medical device world is competitive, healthcare is cost driven, and deals sometimes come down to pennies per item. Every physician in your department may want it, but in this climate, the bean counters making the decisions don't care. Your experience and insight in developing a value proposition are important in making the case for your device. Lastly, you probably aren't going to retire because of your product. Unless you want to devote most of your life to it, manufacture and sell it yourself, a more likely outcome will be some upfront cash for the IP and a 6% royalty. You have to decide what path you want to take.  Both are possible, it comes down to what is best for you and your family. 

 

Patent protection

You mean I have to deal with an attorney?!? Yes and no. You have all the skills in the world to apply for your own provisional patent.  View this as a line holder. It will give you protection for a year and can be done by yourself, a reputable online legal service or by an attorney. It may not be a bad idea to shop some attorneys around. Some may even do the provisional for a reduced fee, knowing that you will come back to them to do the utility patent. Read up, learn about patents, search some on Google patent and get an idea of what goes into them. When it comes time to do the full utility patent, unless you have a strong handle on it, hire a patent attorney. They are worth their fees and if you ever have any challenges to your IP, their ninja like skills will be essential to navigate you through the process. 

 

Market research and value proposition

This is what you can be doing in the meantime. Come up with a two page document that lays out why your concept needs to be in use. Be realistic, you will not get 100% of the market share and the FDA is not likely to mandate its use. Useful information to collect will be number of procedures done annually, current standards of care, what you aim to replace, potential competitors and their cost, time savings, money savings (or increase in some instances), CPT codes and billing issues associated with your concept, etc... The more info you have to sell your case the better. 

 

Regulatory

This is a very complex topic. Which category your product falls into in terms of FDA classification will have a big impact on the time your product will take to make it through to the end. My team has chosen to focus on lower tech products for this very reason. Anything that is invasive, has electronic components, or deals with drug delivery will have more scrutiny, and more cost, associated with it. It's important to identify predicate, or similar, devices that your device will be compared to. If your product is totally new and there are no predicate devices, you may benefit from finding a company that specializes in regulatory assessment. You may be spending some money here, but the information that this individual provides is important, and any potential company you partner with will need to know this information. Become familiar with the different classifications, more information can be found on the FDA website. 

 

Prototype

Many ideas start out as a drawing on a piece of paper on your overnight shift one weekend. Keep track of these drawings and date them. Also, keep track of who you share it with and try to keep that to a minimum. That can be hard to do when you are excited, but there are many horror stories of people's concepts being stolen. Search your local area for a 3-D illustrator or find a local college kid in the engineering department who may want some beer money. You're an ED doc, you know how to be resourceful. Fortunately, 3-D printers are becoming commonplace, and for a few hundred dollars or so, you may be able to get a loosely working prototype to give you something to show potential partners. As with all stages of this process, the more you have is likely better. 

 

Finding a commercial partner

The fun part. Kind of like finding the right person to admit the diabetic GI bleeder with a broken hip. Early on start identifying potential partners. Keep a running list, utilize sources such as LinkedIn to find decision makers inside companies. Good people to start with are heads of new business development, marketing, research and development. We have sometimes had success developing a relationship with a local sales rep and learning the chain of command. Some companies develop all ideas in house and view physicians as pests. Some actively seek out new ideas. Every company is different. Once you've made a good contact, get a non-disclosure agreement in place before indulging too much. Standard NDAs can be found online. Get it signed and create a DropBox account and start sharing the concept. 

 

Signing a deal

If you have a friend in the device field, get some feedback and set realistic expectations. If all you have is a provisional patent and no working prototype, you are not likely to get $100k upfront. Some companies simply will not pay for IP unless the full utility patent has been issued. Royalties are important and you want to make sure that you don't overshoot here. 6% is industry standard. That may seem greedy on their part but understand they are taking a risk, assuming all responsibility for development, molding, training, marketing and advertising. And if any IP challenges come up, they will likely be covering this as well. It may serve you to have a trusted attorney involved in this process as purchase agreements may be in excess of 100 pages. 


Summary

Good luck. It’s a long process. It is expensive. There is no guarantee of success. Would I go through it all over again? I don’t know the answer to that quite yet. It certainly is delayed satisfaction, and it hasn’t paid itself off yet.

 

I am happy to help/answer questions. Contact info below, feel free to connect on LinkedIn.

 

Sincerely,

Patrick O’Malley, MD

omalleypat@mac.com

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© 2017 by Nisha Mehta, MD