Out of Committee: Device Development: 1% Inspiration, 99% Perspiration and Regulation
Anand K. Devaiah, MD Adapted from a talk given to the New England Otolaryngology Society Meeting, December 2013, Yale University. Otolaryngology is a technology-driven field. This is well known to AAO-HNS members. Many of our advances as a field can be connected to our adoption and development of new technology. Everyone reading this article has designed, used, or benefited from a medical device in some way. Hence, it won’t surprise many of you to know that technology spending accounted for $331 billion globally last year1. Regardless of the depth to which you engage in medical devices, it is important to have a working knowledge of how one brings a device from idea to fruition. Certainly, for those who want to create new and better ways to help patients, this is obvious. However, it is key for the end-user to understand this, too. Why? We should all be aware of the process and where rules are imposed to provide measures of safety and regulation. Still not convinced? Have you attended a meeting or had a device manufacturer approach you to try its “newest thing”? You should be able to ask the right questions to assess the process by which that device came to be in your hands, at that moment, and certainly before it ends up in your clinic or operating room. Below is a way of framing these processes, but not certainly the only ways nor the only philosophies. Start the Process There are lots of ways to approach device development. It is usually best to start with a problem you encounter, which inspires you to wonder “If I only had something that did this…” Without the inspiration to fuel a drive for innovation, ideas remain ideas and will not often see the light of day. As one looks down the road at signposts for success, investors you may court to invest in your idea look at the passion behind the people and not just the idea. Design 101 Start with draft drawings of what you have in mind. This will often help you cement the device’s functions and form. It is helpful to search for existing devices that have been patented or are patent-pending. It is quite disappointing to go through the development process only to find that someone else has already done what you want to do. There are many ways to search for “prior art,” such as at the U.S. Patent Office (USPT.gov) and Google patents. It is important to note, and is apparent when you start searching patents, that intellectual property (IP) for devices can be difficult to protect. Making a few simple material changes can make a device “unique,” and may be difficult to keep your device protected. Alternatively, this could work in your favor if you can improve and differentiate your device from something that exists. Of course, you should adhere to the highest ethical standard in these efforts. Critically Appraise your Design It is easy to be enthusiastic about your idea, and you should be. However, it is tough to be critical about what you have designed. Ask questions of your idea. Does it accomplish what you want it to do? Does it change, for the better, how you and your colleagues accomplish the same task? Is it ergonomic? Can it be built? Do you think your market will accept this new idea? There are many others that you can and should consider, but these are a good start. Build a Prototype There are different ways to take your design to a prototype. For those who wish to work alone during this part of the process, there are a number of approaches. There are growing numbers of rapid prototyping facilities that use computer-aided design to create models. Rapid prototyping with 3D printing has become an accessible way to do this. Other methods include machine shop or other fabrication to build your prototype or working model. Depending on what you are designing, there are other options to consider. Funding Options to Move Your Project Along This can vary, based on your type of practice setting and resources available. For university-based practitioners, there are often internal mechanisms for technology development. This can include seed funding for projects, patent development, company development, and others. The U.S. government2 has a number of options that may fit your goal. This can include Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR), R21 grant mechanisms, and other ways. Industry partnerships are another way to move your project along. They can be involved at a number of points along the way to market. Other places to consider include foundations that may have funding mechanisms that may support a project in line with their goals. For larger projects where you may even consider building a company out of your idea, angel investors and venture capitalists may be a route to go. An interesting and growing mechanism is crowd-sourced funding (e.g., Kickstarter). Patent Basics There are three types of patents that you can apply for3,4: utility, design, and plant. Utility patents are granted for new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. Design patents are granted for new, original, and ornamental design for an article of manufacture. Although not germane to this article’s focus, plant patents are granted for inventing or discovering and asexually reproducing any distinct and new variety of plant. An important distinction is that utility patents protect the way an article is used or works, while a design patent protects the way an article looks. Therefore, utility and design patents may be applied to the same invention. When applying, there are two basic patent protections to apply for: provisional patents and full patents. A provisional patent (i.e. “patent pending”) gives you a year of patent protection. During this time, you can have protection for your invention, and decide on whether you would want to get a full patent. A full patent gives you 20 years of protection from the date of issue, which ends up being about 17-18 years when considering the lead time to issuance. In 2011, the America Invents Act brought some changes to the patent system, which can be debated as to how sweeping these were or were not. Of interest is that there was a change from a “first to invent” to a “first to file” in regard to granting a patent; the first to file is given patent protection. If you are going to go international with your device, remember that international patent protection is important to consider, as a U.S. patent only protects you in the United States. Working with the FDA for Approval New devices require FDA approval before they can be used in practice5. There are two pathways for approval: 510K and the Premarket Approval Process (PAP). The 510K process is the overwhelmingly used method, and generally requires less background work for approval. It can only be used for devices that are a substantial equivalent to a previously approved device. The PAP is more rigorous, requires scientific studies of the device’s use, and is necessary for those devices that would not qualify under the 510K mechanism. The FDA has three classifications of devices: Class I (a “general control,” least regulated, exempt from PAP); Class II (general control with special control which is sometimes exempt); and Class III (general controls requiring PAP and the most tightly regulated). The time and cost required to bring devices to market varies, with greatest amounts for Class III devices, in general. Where Do We Go From Here? AAO-HNS members are encouraged to read more on the topics in this article, and others related to device development, for an in-depth discourse. Hopefully the information in this article helps answer many questions you may have about the processes and philosophies behind development. It should be clear to the reader why modifying Thomas Alva Edison’s quote to fit this article seemed to be most appropriate, with a most respectful nod to his genius. I hope that you will enjoy subsequent articles coming from the Medical Devices and Drugs Committee, as part of a newly launched series. References 1. Mosquera M. http://www.healthcarefinancenews.com/news/medical-devices-grow-3-percent-2012. Accessed Nov. 29, 2013. 2. USPT.gov. Accessed Nov. 29, 2013. 3. NIH.gov. Accessed Nov. 29, 2013. 4. Patent Pending in 24 hours. Stim R. and Pressman D. 1st edition. Nolo publishing, 2002 5. FDA.gov. Accessed Nov. 29, 2013. Anand K. Devaiah, MD, is Associate Professor of Otolaryngology, Neurological Surgery, and Ophthalmology, and the Chair of the Medical Devices and Drugs Committee for the AAO-HNS, and editor for the Bulletin article series from this Committee. Please feel free to direct any questions to him at anand.devaiah@bmc.org, or to the committee liaison, Harrison Peery (hpeery@entnet.org). Have a suggestion on a future article? Let us know! Relevant disclosures: Dr. Devaiah does not have a relationship with any commercial entities discussed in this article; he has owned financial instruments related to Google, Inc., which is a company mentioned in this article.
Anand K. Devaiah, MD
Adapted from a talk given to the New England Otolaryngology Society Meeting, December 2013, Yale University.
Otolaryngology is a technology-driven field. This is well known to AAO-HNS members. Many of our advances as a field can be connected to our adoption and development of new technology. Everyone reading this article has designed, used, or benefited from a medical device in some way. Hence, it won’t surprise many of you to know that technology spending accounted for $331 billion globally last year1.
Regardless of the depth to which you engage in medical devices, it is important to have a working knowledge of how one brings a device from idea to fruition. Certainly, for those who want to create new and better ways to help patients, this is obvious. However, it is key for the end-user to understand this, too. Why? We should all be aware of the process and where rules are imposed to provide measures of safety and regulation. Still not convinced? Have you attended a meeting or had a device manufacturer approach you to try its “newest thing”? You should be able to ask the right questions to assess the process by which that device came to be in your hands, at that moment, and certainly before it ends up in your clinic or operating room. Below is a way of framing these processes, but not certainly the only ways nor the only philosophies.
Start the Process
There are lots of ways to approach device development. It is usually best to start with a problem you encounter, which inspires you to wonder “If I only had something that did this…” Without the inspiration to fuel a drive for innovation, ideas remain ideas and will not often see the light of day. As one looks down the road at signposts for success, investors you may court to invest in your idea look at the passion behind the people and not just the idea.
Design 101
Start with draft drawings of what you have in mind. This will often help you cement the device’s functions and form. It is helpful to search for existing devices that have been patented or are patent-pending. It is quite disappointing to go through the development process only to find that someone else has already done what you want to do. There are many ways to search for “prior art,” such as at the U.S. Patent Office (USPT.gov) and Google patents. It is important to note, and is apparent when you start searching patents, that intellectual property (IP) for devices can be difficult to protect. Making a few simple material changes can make a device “unique,” and may be difficult to keep your device protected. Alternatively, this could work in your favor if you can improve and differentiate your device from something that exists. Of course, you should adhere to the highest ethical standard in these efforts.
Critically Appraise your Design
It is easy to be enthusiastic about your idea, and you should be. However, it is tough to be critical about what you have designed. Ask questions of your idea. Does it accomplish what you want it to do? Does it change, for the better, how you and your colleagues accomplish the same task? Is it ergonomic? Can it be built? Do you think your market will accept this new idea? There are many others that you can and should consider, but these are a good start.
Build a Prototype
There are different ways to take your design to a prototype. For those who wish to work alone during this part of the process, there are a number of approaches. There are growing numbers of rapid prototyping facilities that use computer-aided design to create models. Rapid prototyping with 3D printing has become an accessible way to do this. Other methods include machine shop or other fabrication to build your prototype or working model. Depending on what you are designing, there are other options to consider.
Funding Options to Move Your Project Along
This can vary, based on your type of practice setting and resources available. For university-based practitioners, there are often internal mechanisms for technology development. This can include seed funding for projects, patent development, company development, and others. The U.S. government2 has a number of options that may fit your goal. This can include Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR), R21 grant mechanisms, and other ways. Industry partnerships are another way to move your project along. They can be involved at a number of points along the way to market. Other places to consider include foundations that may have funding mechanisms that may support a project in line with their goals. For larger projects where you may even consider building a company out of your idea, angel investors and venture capitalists may be a route to go. An interesting and growing mechanism is crowd-sourced funding (e.g., Kickstarter).
Patent Basics
There are three types of patents that you can apply for3,4: utility, design, and plant. Utility patents are granted for new and useful process, machine, article of manufacture, or composition of matter, or any new and useful improvement thereof. Design patents are granted for new, original, and ornamental design for an article of manufacture. Although not germane to this article’s focus, plant patents are granted for inventing or discovering and asexually reproducing any distinct and new variety of plant. An important distinction is that utility patents protect the way an article is used or works, while a design patent protects the way an article looks. Therefore, utility and design patents may be applied to the same invention. When applying, there are two basic patent protections to apply for: provisional patents and full patents. A provisional patent (i.e. “patent pending”) gives you a year of patent protection. During this time, you can have protection for your invention, and decide on whether you would want to get a full patent. A full patent gives you 20 years of protection from the date of issue, which ends up being about 17-18 years when considering the lead time to issuance. In 2011, the America Invents Act brought some changes to the patent system, which can be debated as to how sweeping these were or were not. Of interest is that there was a change from a “first to invent” to a “first to file” in regard to granting a patent; the first to file is given patent protection. If you are going to go international with your device, remember that international patent protection is important to consider, as a U.S. patent only protects you in the United States.
Working with the FDA for Approval
New devices require FDA approval before they can be used in practice5. There are two pathways for approval: 510K and the Premarket Approval Process (PAP). The 510K process is the overwhelmingly used method, and generally requires less background work for approval. It can only be used for devices that are a substantial equivalent to a previously approved device. The PAP is more rigorous, requires scientific studies of the device’s use, and is necessary for those devices that would not qualify under the 510K mechanism. The FDA has three classifications of devices: Class I (a “general control,” least regulated, exempt from PAP); Class II (general control with special control which is sometimes exempt); and Class III (general controls requiring PAP and the most tightly regulated). The time and cost required to bring devices to market varies, with greatest amounts for Class III devices, in general.
Where Do We Go From Here?
AAO-HNS members are encouraged to read more on the topics in this article, and others related to device development, for an in-depth discourse. Hopefully the information in this article helps answer many questions you may have about the processes and philosophies behind development. It should be clear to the reader why modifying Thomas Alva Edison’s quote to fit this article seemed to be most appropriate, with a most respectful nod to his genius. I hope that you will enjoy subsequent articles coming from the Medical Devices and Drugs Committee, as part of a newly launched series.
References
1. Mosquera M. http://www.healthcarefinancenews.com/news/medical-devices-grow-3-percent-2012. Accessed Nov. 29, 2013.
2. USPT.gov. Accessed Nov. 29, 2013.
3. NIH.gov. Accessed Nov. 29, 2013.
4. Patent Pending in 24 hours. Stim R. and Pressman D. 1st edition. Nolo publishing, 2002
5. FDA.gov. Accessed Nov. 29, 2013.
Anand K. Devaiah, MD, is Associate Professor of Otolaryngology, Neurological Surgery, and Ophthalmology, and the Chair of the Medical Devices and Drugs Committee for the AAO-HNS, and editor for the Bulletin article series from this Committee. Please feel free to direct any questions to him at anand.devaiah@bmc.org, or to the committee liaison, Harrison Peery (hpeery@entnet.org). Have a suggestion on a future article? Let us know!
Relevant disclosures: Dr. Devaiah does not have a relationship with any commercial entities discussed in this article; he has owned financial instruments related to Google, Inc., which is a company mentioned in this article.