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Orthopaedic Product Development: Steps to Success

Published: March 7, 2011
By: Dawn A. Lissy
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Understanding how every aspect of product development ties together is vital, especially when developing implants.

Bringing a medical device to market in a timely fashion requires having a realistic understanding of the regulatory approval process and the steps necessary to ensure a device is safe and effective. This type of knowledge is not typically learned in school but is critical to the success of a product development cycle. Specifically for orthopaedic devices, an intimate understanding of every aspect of the product development cycle and the unique team players (i.e., surgeon champions, regulatory agencies, etc.) can make or break the timeline for product commercialization. Planning to meet milestones while also avoiding obstacles and dealing with roadblocks is critical to success in every phase of the process. This article highlights the elements that help to achieve that success.
Figure 1. Orthopaedics manufacturers must have a strong understanding off all aspects of the product development cycle.

The Fundamental Components

As U.S. economist and social philosopher Thorstein Veblen once stated, "Invention is the mother of necessity." The goal of all medical device companies is to create a safe, effective, and profitable device that will receive marketing approval from FDA and all other applicable regulatory bodies. Contemporary American computer scientist Alan Kay stated the goals of any business in a much more pragmatic fashion, "The best way to predict the future is to invent it." With the maturation of the hip and knee market, the evolution of interbody fusion devices from allografts, and the rise of dental implants, the orthopaedics market has seen significant progress during the past 25 years.
 
The major components of the product development cycle include concept, development, testing, regulatory approval, production, and ultimately, "to market" (see Figure 1). During the concept phase, a complete presentation is made to the management team in order to determine if the project is feasible. When addressing the concept, the following key questions must be answered:
  • What is the market need? Is this product creating a new market and solving a legitimate clinical need? If not, how many competitors exist in this product space? Well-meaning medical device developers can become myopic in their examination of the true market need for their device. Being new or novel is not enough. A successful new device must solve a problem while being easy to use and cost effective to buy. In fact, in today's healthcare environment, need is not enough. Economy must also be a consideration.
     
  • What is the market potential?  Does this product have the potential to be used 10 times per year or 10 million times per year? What is the potential sales price of this device? Does it fall into existing insurance coding for reimbursement? Bringing medical devices to market while maintaining all the infrastructure necessary to legally sell a safe and effective product is not inexpensive. The long-term sustainability of a market must balance the product development, approval, and marketing costs that a medical device company will accrue.
     
  • Who are the surgeon champions? Defining the end-user experts is crucial to the success of a product. The surgeons will not only help to create the best device, but also be the face of the device for training purposes and peer-recognized usage. One of the best things that can happen to the product development cycle is the enthusiastic involvement of a thought leader for a specific device.
     
  • What is the development time? Will the product take six months to develop before a submission to the regulatory agencies or several years?  What is the regulatory strategy and time commitment (i.e. Class I, II, or III device)? Development time is a direct function of regulatory expectations. For instance, define a regulatory strategy very early in the process and this will help define the product development cycle. Development and testing times are a direct function of the risk of a device. Sometimes the best strategy is to first obtain low-risk indications for use, get the product on the market, and then add design enhancements and clinical indications in generation two of the device.
     
  • What are the parameters to define a design freeze? This critical point is typically considered in hindsight. It is crucial for the product manager to have an agreement with management on the parameters required for a design freeze or budgets, expectations, and time to market will be adversely affected. Define the acceptance criteria for the device early and remember that receiving one product approval is not usually the end of the process. Instead, the first approval is simply a stepping stone for future enhancements and expanding markets.
Once the determination has been made to develop a product, the first decision should be identification of an experienced project manager. As the manager of the team, his or her responsibilities include, but are not limited to, defining:
  • Type of device (if not already defined).
  • Regulatory path.
  • Project timelines and milestones (and managing them).
  • Team members and ensuring that each person meets the expectations for their role.
  • How to anticipate and overcome road blocks that will inevitably enter into the process.
Surgeon Champions. The surgeons help to determine the need and market potential for the device, and they also might be the group to bring the concept to the management team. This subteam is critical in helping to define the final design features, instruments, surgical technique, and delivery method, as well as in playing an instrumental role in the clinical trials that may be required of a device. Training courses and showcasing the benefits of a device to other potential users are also key roles for surgeons. Having several surgeon champions for a particular device creates an opportunity for differing viewpoints and experience, and as a result, harmony between team members is also important for success.
 
Engineering Team. The engineering subteam is responsible for taking the vision of the management team and the surgeon champions to create a device that is cost-effective, easy to use, easy to manufacture, safe, and effective, while optimizing any and all leading-edge technologies. After the design is complete, a comprehensive assessment, including a failure modes and effects analysis, must be performed. This process will give the management team an understanding of any potential risks and liabilities to the company.
 
Lastly, the role of the engineering team does not end with the glamour of a completed design. This team must also bring together approved manufacturing vendors, complete design controls, inspection instructions, contamination, cleaning and sterilization testing, packaging design and validation, and approved design specifications, along with all other aspects of a required quality assurance system.
 
Regulatory Team. The regulatory team is integral in determining the appropriate regulatory path, timeline for approval, and the potential costs. For instance, a pedicle screw system is typically a Class II device and takes approximately four to six weeks of testing, while an artificial disc is a Class III device and takes approximately six to nine months of testing. This subteam is primarily responsible for compiling a complete package for regulatory submission. This package includes being aware of all specific requirements for each regulating body (FDA, European Union, etc.) and may include internal and external team members. Identifying the correct members for this subteam is imperative to the cycle time success. For example, if the device is submitted under the wrong product code, has holes in the submission, or does not answer certain questions, the overall burn rate has the potential to double or triple at this stage.
 
Mechanical Testers. The most overlooked or undervalued team at the beginning of the product development cycle is the team responsible for the mechanical testing, or in regulatory terms, the group responsible for evaluating the safety and efficacy of a device. Do you need computer modeling, bench top testing, biocompatibility, cadaveric studies, animal studies, clinical studies, or all of the above?  Defining the risks of your device will help the mechanical test team determine what type of testing needs to be done to answer the question: Is this device safe and effective? 
 
Once you understand what testing needs to be done, the next question is where it will be conducted. Whether an internal or an external testing facility is used to characterize the device, there are factors that must be considered by the product development manager. When outsourcing testing, an ideal testing facility should be accredited to ISO/IEC 17025:2005 as well as the standard to which the testing should adhere. Other pertinent factors to consider when choosing this subgroup include relevant experience, price versus value, queue time, and the final technical document. It is important to understand if this group provides feedback on the test strategy and protocol, if they deliver a comprehensive and accurate cost estimate (including timeline), and if they understand the pitfalls of the test methods. Each method has deviations or factors to consider including, but not limited to, device material, test environment, frequency, appropriate equipment, and symbiotic services. 
 
Management Team. With all of these diverse and specialized roles of the team players, it is essential that the management team supports the product development team manager, as well as the surgeon champions, engineering team, regulatory group, and test facilities in order to launch a successful product in a timely manner.
 

Next Step: Product Timelines and Milestones

Now that the team has been assembled and the end product identified, what are the factors that affect the timeline and what are the critical milestones (see Figure 2 )? During some aspects of the timeline, it is nearly impossible to determine the total time required to complete that phase unless some specific parameters are created or provided. For example, how much time should be spent on R&D (how many iterations of the design, how many prototypes, cadaver labs, etc.) before a design freeze?  After the design has been frozen, some feasibility testing, either by a mechanical evaluation or a cadaver lab, should be employed to ensure that the team is on the right path. In conjunction, garnering feedback from the surgeon team at this point will ensure when it is the appropriate time to finalize the designÑotherwise the team may be going through a few iterations. The manufacturing arm of the engineering group is now responsible for optimizing the manufacturing process while including considerations for technology, speed, repeatability, traceability, cost, and quality for the device, any and all instruments, and the packaging (whether in sterile packs or cases).
 
Figure 2. The critical milestones in a successful product development cycle. (click on image to open larger version)
 
The last step before the actual submission is typically reserved for mechanical testing or device characterization, which is usually required for any Class II or III device. When determining the timing of mechanical testing, a rough estimate can be calculated (frequency of testing X number of specimens X endurance value cycle count). However, this area is one in which extra time should be considered. The testing cannot progress any faster, and if the initial results are not what were anticipated, the testing phase can potentially take two to three times longer than what was anticipated due to design changes and remanufacturing of test parts. Another important factor to consider when putting together the project plan is the cost of testing. An average battery, depending on the device, can range from $1000 to $250,000. Not only is there the cost of the testing activities, but since this is typically destructive testing, there is also the cost of manufacturing a small batch of specimens (with potentially multiple rounds testing) that must be included.
 
The last potential consideration is predicate device testing. In the case of a Class II device, predicate data must be included in the submission, whether by citing published data or providing a side-by-side comparison in mechanical testing. Providing side-by-side testing will potentially add significant cost and time to the overall timeline as well. After this step is complete, the package is compiled and submitted to request marketing approval.
 
After pouring blood, sweat, and tears into your project from anywhere between six and 66 months, the final package is ready to be sent to regulatory agencies. Waiting for feedback, questions and ultimately marketing approval can be the most difficult part of the process for the management team and the team members. After all feedback has been addressed you finally reach marketing approval.
 
Many team players, from management to sales, are critical to the success of any product development cycle. Planning, working together, anticipating and overcoming roadblocks, having the right team players, and having good management of the process are the keys to success.
 
Dawn A. Lissy is president and CEO of Empirical Testing Corp. (Colorado Springs, CO).
Find Empirical Testing Corp. at booth # 405 at OrthoTec 2011.

Published in Orthotec, April/May 2011, Volume 2, No. 2


Dawn A. Lissy
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