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In my previous article, “Creating Exponential Value, Part I: How Far Should You Take Your Idea?” we learned that the further you take your idea, the more valuable it will be to a prospective buyer. In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects of product development from the very onset, regardless of how far you plan to go. By using an “integrated” approach, you not only maximize the value of your idea, but also minimize the monetary risk that you are assuming.
Let’s say you have an idea for a product that you haven’t seen on the market, and want to develop it through to 510(k) regulatory clearance to get a high return on your investment when selling to a prospective OEM. Let’s walk through a way to accomplish this.
First, you know that several different partners will be needed, so you identify four entities to work with: design firm, testing firm, regulatory consultant and IP attorney. You’ll start by having the design firm create 3D CAD models of your concept and then develop a prototype. Next, you’ll do a cadaver lab or saw bones evaluation to make sure you’re comfortable with the feasibility of the device.
You decide you’re ready to take the next steps. What should you do next: biomechanical testing, intellectual property evaluation, regulatory pathway determination, assessment of manufacturability or cost? Well, since your goal is to get 510(k) clearance, and you know that testing will likely be needed, maybe you should contact a testing lab next. After you finish testing, you can start to work with the regulatory firm to get the 510(k) drafted. After all, the other items aren’t needed for 510(k) clearance. And while FDA is reviewing your submission, you can have your IP attorney look at patentability and infringement, and the other questions (manufacturability and cost) will be handled by the prospective OEM buyer. Sounds like a good plan, right?
In reality, you probably aren’t optimizing your chances for success with this “piecemeal” approach. Let’s examine what I mean by piecemeal. Consider the analogy to building a new home. There are two basic ways to do this—hire individual subcontractors on your own, or hire a general contractor who will select the subcontractors and manage all of the activities. Individual contractors may be very well-qualified and do great work, but they will only be considering the specific narrow-focused task that you hired them to do. (You wouldn’t want a contractor that pours the foundation for your new home to have no regard for the future framing or plumbing.) A general contractor is going to develop a thorough plan and ensure that all future activities are considered every step of the way.
Medical device development is similar in that all aspects of product development need to be considered and integrated into the design from the very start to ensure project success.
Let’s revisit your plan. Your first step was to hire a design firm to create 3D models. The firm may have done a great job translating your inputs into a CAD model and a prototoype. But did they consider and incorporate other critical product development aspects into the design?
Specifically, did they consider these four key questions?
- What will be the regulatory pathway for the device, and what predicate device(s) might you use for your regulatory submission?
- What are the performance requirements of the device, and how are the requirements evaluated?
- What does the IP landscape look like for this type of device?
- Will this device be manufacturable at a reasonable cost?
Why does all of this matter so early in the project?
1. What will be the regulatory pathway for the device, and what predicate device(s) might you use for your regulatory submission?
Although you want your device to be “novel,” you probably aren’t interested in going down the expensive and time consuming path of doing clinical trials, getting PMA approvals, etc., so you’ll want to make sure that your device can be cleared via the 510(k) pathway. To do this, you’ll need to identify a potential predicate device that has the same indications for use and similar technology as what you are intending. By identifying this early in the design phase, your design engineer can design with the intent of maximizing your chances of success in subsequent testing and regulatory phases.
2. What are the performance requirements for the device, and how are they evaluated?
What are the potential failure modes for your device? How do you plan to show substantial equivalence to a predicate? If you aren’t able to show equivalence to a predicate during testing, you will have to go back to the drawing table with a redesign and then manufacture a new round of prototypes. By identifying failure modes and potential test methodology early, your design will already be optimized for success before you enter the testing phase.
3. What does the IP landscape look like for this type of device?
Imagine ignoring this question until after your 510(k) submittal, then hiring a patent attorney, spending thousands of dollars and only then discovering that your design infringes on one already on the market. Many projects are canceled at this point due to lack of funding, when there may have been a simple design tweak that could have been made early in the design phase to avoid infringement.
In addition, how important is patentability? While not always essential, you should consider this early in the project, since your design could be affected by the findings of an IP attorney.
4. Will the device be manufacturable at a reasonable cost?
If you’ve done some homework upfront and have a business plan put together, you’ll have a pretty good idea of target cost and selling price for your device. If profitability isn’t high enough, OEMs probably won’t be interested. Many ideas are clearly novel, but without substantial clinical differentiation, you need to keep your eye on cost to be competitive with other devices in your market space. To do this, you need to assess the manufacturability of your device early in the design phase so that the cost to produce can be optimized and the profitability maximized.
When these key factors are considered and integrated into your design early in the project, you will optimize your chances for success and maximize the value of your investment. This requires an integrated approach to product development.
In my previous article, “Creating Exponential Value, Part I: How Far Should You Take Your Idea?” we learned that the further you take your idea, the more valuable it will be to a prospective buyer. In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects...
In my previous article, “Creating Exponential Value, Part I: How Far Should You Take Your Idea?” we learned that the further you take your idea, the more valuable it will be to a prospective buyer. In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects of product development from the very onset, regardless of how far you plan to go. By using an “integrated” approach, you not only maximize the value of your idea, but also minimize the monetary risk that you are assuming.
Let’s say you have an idea for a product that you haven’t seen on the market, and want to develop it through to 510(k) regulatory clearance to get a high return on your investment when selling to a prospective OEM. Let’s walk through a way to accomplish this.
First, you know that several different partners will be needed, so you identify four entities to work with: design firm, testing firm, regulatory consultant and IP attorney. You’ll start by having the design firm create 3D CAD models of your concept and then develop a prototype. Next, you’ll do a cadaver lab or saw bones evaluation to make sure you’re comfortable with the feasibility of the device.
You decide you’re ready to take the next steps. What should you do next: biomechanical testing, intellectual property evaluation, regulatory pathway determination, assessment of manufacturability or cost? Well, since your goal is to get 510(k) clearance, and you know that testing will likely be needed, maybe you should contact a testing lab next. After you finish testing, you can start to work with the regulatory firm to get the 510(k) drafted. After all, the other items aren’t needed for 510(k) clearance. And while FDA is reviewing your submission, you can have your IP attorney look at patentability and infringement, and the other questions (manufacturability and cost) will be handled by the prospective OEM buyer. Sounds like a good plan, right?
In reality, you probably aren’t optimizing your chances for success with this “piecemeal” approach. Let’s examine what I mean by piecemeal. Consider the analogy to building a new home. There are two basic ways to do this—hire individual subcontractors on your own, or hire a general contractor who will select the subcontractors and manage all of the activities. Individual contractors may be very well-qualified and do great work, but they will only be considering the specific narrow-focused task that you hired them to do. (You wouldn’t want a contractor that pours the foundation for your new home to have no regard for the future framing or plumbing.) A general contractor is going to develop a thorough plan and ensure that all future activities are considered every step of the way.
Medical device development is similar in that all aspects of product development need to be considered and integrated into the design from the very start to ensure project success.
Let’s revisit your plan. Your first step was to hire a design firm to create 3D models. The firm may have done a great job translating your inputs into a CAD model and a prototoype. But did they consider and incorporate other critical product development aspects into the design?
Specifically, did they consider these four key questions?
- What will be the regulatory pathway for the device, and what predicate device(s) might you use for your regulatory submission?
- What are the performance requirements of the device, and how are the requirements evaluated?
- What does the IP landscape look like for this type of device?
- Will this device be manufacturable at a reasonable cost?
Why does all of this matter so early in the project?
1. What will be the regulatory pathway for the device, and what predicate device(s) might you use for your regulatory submission?
Although you want your device to be “novel,” you probably aren’t interested in going down the expensive and time consuming path of doing clinical trials, getting PMA approvals, etc., so you’ll want to make sure that your device can be cleared via the 510(k) pathway. To do this, you’ll need to identify a potential predicate device that has the same indications for use and similar technology as what you are intending. By identifying this early in the design phase, your design engineer can design with the intent of maximizing your chances of success in subsequent testing and regulatory phases.
2. What are the performance requirements for the device, and how are they evaluated?
What are the potential failure modes for your device? How do you plan to show substantial equivalence to a predicate? If you aren’t able to show equivalence to a predicate during testing, you will have to go back to the drawing table with a redesign and then manufacture a new round of prototypes. By identifying failure modes and potential test methodology early, your design will already be optimized for success before you enter the testing phase.
3. What does the IP landscape look like for this type of device?
Imagine ignoring this question until after your 510(k) submittal, then hiring a patent attorney, spending thousands of dollars and only then discovering that your design infringes on one already on the market. Many projects are canceled at this point due to lack of funding, when there may have been a simple design tweak that could have been made early in the design phase to avoid infringement.
In addition, how important is patentability? While not always essential, you should consider this early in the project, since your design could be affected by the findings of an IP attorney.
4. Will the device be manufacturable at a reasonable cost?
If you’ve done some homework upfront and have a business plan put together, you’ll have a pretty good idea of target cost and selling price for your device. If profitability isn’t high enough, OEMs probably won’t be interested. Many ideas are clearly novel, but without substantial clinical differentiation, you need to keep your eye on cost to be competitive with other devices in your market space. To do this, you need to assess the manufacturability of your device early in the design phase so that the cost to produce can be optimized and the profitability maximized.
When these key factors are considered and integrated into your design early in the project, you will optimize your chances for success and maximize the value of your investment. This requires an integrated approach to product development.
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SL
Stuart Lindquist is a Project Engineer for Kapstone Medical, LLC, an engineering and consulting firm that partners with surgeon inventors and orthopaedic implant companies to develop and commercialize new medical devices. Stuart is an experienced medical device engineer with over 15 years of experience. Prior to Kapstone, he was a Project Leader for Zimmer, Inc., developing knee implant and instrumentation systems.
