David C. Kelman, President, Kelman & Company Consulting LLC08.15.18
Design surgeons and surgeon design times have been at the core of the significant advances that have occurred in the medical device market in the last few decades. Working with surgeon design teams is inspirational, mentally demanding, and exciting.
Let’s assume a new opportunity has been identified that will improve your organization’s financial position. The marketing team has studied the market space—that is, classified at least three types of current and potentially new innovative strategies this opportunity should incorporate (as was described in the March/April 2018 issue of ODT, “Innovation and the Development Engineer”).
Once a complete financial plan, which includes cost to develop/introduce, and a sales/marketing plan have both been vetted and approved by the organization’s senior staff, it is time to move ahead to develop the surgeon design team.
I have had experience with two different types of surgeon design teams. The first—a “Hub and Spoke” model—was utilized in situations where aligning with a given group of surgeons or an institution would alienate others from using the product once it was released. The second is the more traditional surgeon design team with a group of surgeons selected to work on a project from beginning to end.
The Hub and Spoke model concept relies on one or two core key opinion leading (KOL) surgeons to serve as the hub of the wheel. Different surgeons or groups of surgeons meet independently with the KOL surgeon and the development engineering lead at a series of low-key meetings held at various time points to obtain feedback on different aspects of the design. There is a significant amount of reliance placed upon the KOL surgeon as the amount of involvement of the non-KOL surgeons is substantially less than in a traditional surgeon design team model. In this model, the non-KOL surgeons are assisting with validating the market assessments and need requirements, as well as providing market acceptance feedback of the new product later in the process. It is the responsibility of the KOL surgeon and the development staff to turn that information into a viable product.
With the more common traditional surgeon design team, assembling a good design team is critical to the success of the endeavor. The product development team needs to work closely with the marketing department in the selection and assembly of the surgeon design team. The selection process is very much like picking players for a team sport. The desire is to pick the most talented team, with personalities that mesh with each other while becoming aligned to win in the same way.
The training and clinical experience of the surgeons, the number of surgeons on the team, and their geographic locations are just a few of the important factors to be considered. The surgeon’s CV is a great reference as are their publications to discover where and by whom they were trained, as well as if they have any won any awards or honors. This process helps an organizer begin to understand a surgeon’s philosophy so as to determine if it matches with the objectives of the project. If these elements do not seem to align, it is best to move on. Further, there are other important considerations—is this the first design team the surgeon has been a part of or is it just the most recent? Has he or she been a part of prior design projects, and if so, what has been the success of those products? You need to fully understand the motivation of a surgeon to be a member of a design team.
It is critical the surgeons understand the commitment they will need to make to be part of the design team, as there will be meetings and other activities that will take them away from their clinical practice and surgery. Provide an understanding of the duration of the project and the time periods where their involvement will be greater than other periods as the project progresses. For example, one design project required great commitment from the surgeons as it met approximately every two to three weeks and for full weekends. As a result of the commitment from the surgeons and support of the company, a very large implant/instrument project was conceived and introduced in 18 months. Conversely, projects without full commitment from all surgeons has resulted in the opposite effect, significantly delaying the project, and doubling the anticipated time to market. Therefore, if the surgeon is not willing to commit the time, they are not a good candidate.
I have had the opportunity to work with a wide group of surgeons from around the world on numerous design teams. All were excellent surgeons, but their interests and how they assisted the design teams varied greatly. There were some true innovators and designers who would design or create their own drawings of new and innovative products. When the product was introduced, they were willing to stand behind the new concept until it was clinically proven, even in the face of being questioned by traditionalists. Others were known for performing clinical studies or understanding the issues surgeons were facing. Still others offered their strengths in addressing the surgical technique. It is crucial to understand the strengths and weaknesses of the members of the design team.
Regarding the project itself, it is vital to have the project well-scoped. The scope needs to be flexible in nature but, at the same time, there need to be boundaries in place to avoid creep and to ensure the end results fulfill the original unmet market requirement. What is the new product or service expected to perform and what is it not going to address? What shouldn’t be addressed is, many times, more important than determining what needs to be. Ensure everyone understands the project’s clinical scope, the financial objectives, and the other innovative aspects desired. In order to keep the team focused and grounded as time progresses, it is often necessary to reflect back upon the scope to avoid derailing and delaying the project.
Having the development engineer/staff gain the respect of the surgeon design team is also important. The engineer must have a wide base of knowledge to keep multiple elements of the development project within his or her view. As the process progresses, certain elements of the product are being locked down that impact the long-term commercial success, design attributes, manufacturability, inventory costs, marketing/sales, user experience, and clinical outcomes. Throughout the project, subject matter experts (e.g., the surgeons, manufacturing engineers, etc.) will provide input and support, but the development engineer is ultimately the one who must sift through all the information and recommendations to decide which to accept, modify, or reject. As such, the development engineer must be a jack-of-all-trades. Leading a development program should not be handled as if it is a democracy, but rather, as a benevolent dictatorship. The leader must listen, assess the situation, make a decision, and move on. Attempting to satisfy all parties will only cause delays.
There are techniques that can be used to help sort through the issues to attempt to make the best decisions. One technique is to note how many times the same concern is raised. If the issue is repeated by numerous surgeons and/or other advisors, it likely requires further exploration. If it is rarely stated or only by one surgeon, it may be safe to consider it a much lower priority. If the factor significantly impacts cost, however, determine how significantly it could impact the marketability of the product.
If a new, creative solution is conceived by a surgeon that seems to have originated from out of left field, it should not be automatically dismissed. Instead, challenge the surgeon to “sell” the idea to the rest of the design team. If he or she cannot earn their acceptance, it may be best to move on. This does not mean the concept was not worthy, but perhaps it needs to be sidelined from the current program and examined independently on its own merits at a later time or for a future generation of the product. Some creative solutions may seem like an idea that makes sense, but ultimately, must be considered within the scope definition for the project.
When having a design meeting, it is important to know the outcome ahead of time. Since design meetings can sometimes become confrontational, first addressing key topics individually with surgeons to understand their concerns and issues will provide a means to be better prepared for the full meeting and make it more productive. If there are controversial issues to be addressed, have one of the surgeon designers present them, which can also assist in making the meeting more productive.
After the concept for the product design has been finalized, enroll a second group of surgeons not part of the original design team to objectively review the new product concept. This can help ensure market acceptance and help identify issues that may have been overlooked. All members of the design team are too close to the project to objectively review the new product. While this review occurs late in the design process, it is still early enough to allow for modifications to be made relativity inexpensively.
Surgeon design teams have been and will continue to be a critical element for the advancement of healthcare in the development of new and innovative medical devices. Leading surgeon design teams is a skill a development engineer needs to hone and refine. It involves technical knowledge, psychology, business acumen, and most importantly, strong leadership attributes.
David C. Kelman, president of Kelman & Company Consulting LLC, is a licensed professional engineer who has managed and led design and development teams on three different continents for major orthopedic companies. He is a creative innovator whose broad scope of solutions has resulted in two unique startup businesses, commercialization of 40 product platforms, and 50 U.S. patents awarded. As a multifaceted problem solver, he incorporates technological and business sophistication across diverse environments, including product design/software/analytics/supply chain/technical marketing and sales. This unique mix of technical, engineering, and business expertise has resulted in successful business strategies, and the introduction of cutting-edge technologies with financial viability.
Let’s assume a new opportunity has been identified that will improve your organization’s financial position. The marketing team has studied the market space—that is, classified at least three types of current and potentially new innovative strategies this opportunity should incorporate (as was described in the March/April 2018 issue of ODT, “Innovation and the Development Engineer”).
Once a complete financial plan, which includes cost to develop/introduce, and a sales/marketing plan have both been vetted and approved by the organization’s senior staff, it is time to move ahead to develop the surgeon design team.
I have had experience with two different types of surgeon design teams. The first—a “Hub and Spoke” model—was utilized in situations where aligning with a given group of surgeons or an institution would alienate others from using the product once it was released. The second is the more traditional surgeon design team with a group of surgeons selected to work on a project from beginning to end.
The Hub and Spoke model concept relies on one or two core key opinion leading (KOL) surgeons to serve as the hub of the wheel. Different surgeons or groups of surgeons meet independently with the KOL surgeon and the development engineering lead at a series of low-key meetings held at various time points to obtain feedback on different aspects of the design. There is a significant amount of reliance placed upon the KOL surgeon as the amount of involvement of the non-KOL surgeons is substantially less than in a traditional surgeon design team model. In this model, the non-KOL surgeons are assisting with validating the market assessments and need requirements, as well as providing market acceptance feedback of the new product later in the process. It is the responsibility of the KOL surgeon and the development staff to turn that information into a viable product.
With the more common traditional surgeon design team, assembling a good design team is critical to the success of the endeavor. The product development team needs to work closely with the marketing department in the selection and assembly of the surgeon design team. The selection process is very much like picking players for a team sport. The desire is to pick the most talented team, with personalities that mesh with each other while becoming aligned to win in the same way.
The training and clinical experience of the surgeons, the number of surgeons on the team, and their geographic locations are just a few of the important factors to be considered. The surgeon’s CV is a great reference as are their publications to discover where and by whom they were trained, as well as if they have any won any awards or honors. This process helps an organizer begin to understand a surgeon’s philosophy so as to determine if it matches with the objectives of the project. If these elements do not seem to align, it is best to move on. Further, there are other important considerations—is this the first design team the surgeon has been a part of or is it just the most recent? Has he or she been a part of prior design projects, and if so, what has been the success of those products? You need to fully understand the motivation of a surgeon to be a member of a design team.
It is critical the surgeons understand the commitment they will need to make to be part of the design team, as there will be meetings and other activities that will take them away from their clinical practice and surgery. Provide an understanding of the duration of the project and the time periods where their involvement will be greater than other periods as the project progresses. For example, one design project required great commitment from the surgeons as it met approximately every two to three weeks and for full weekends. As a result of the commitment from the surgeons and support of the company, a very large implant/instrument project was conceived and introduced in 18 months. Conversely, projects without full commitment from all surgeons has resulted in the opposite effect, significantly delaying the project, and doubling the anticipated time to market. Therefore, if the surgeon is not willing to commit the time, they are not a good candidate.
I have had the opportunity to work with a wide group of surgeons from around the world on numerous design teams. All were excellent surgeons, but their interests and how they assisted the design teams varied greatly. There were some true innovators and designers who would design or create their own drawings of new and innovative products. When the product was introduced, they were willing to stand behind the new concept until it was clinically proven, even in the face of being questioned by traditionalists. Others were known for performing clinical studies or understanding the issues surgeons were facing. Still others offered their strengths in addressing the surgical technique. It is crucial to understand the strengths and weaknesses of the members of the design team.
Regarding the project itself, it is vital to have the project well-scoped. The scope needs to be flexible in nature but, at the same time, there need to be boundaries in place to avoid creep and to ensure the end results fulfill the original unmet market requirement. What is the new product or service expected to perform and what is it not going to address? What shouldn’t be addressed is, many times, more important than determining what needs to be. Ensure everyone understands the project’s clinical scope, the financial objectives, and the other innovative aspects desired. In order to keep the team focused and grounded as time progresses, it is often necessary to reflect back upon the scope to avoid derailing and delaying the project.
Having the development engineer/staff gain the respect of the surgeon design team is also important. The engineer must have a wide base of knowledge to keep multiple elements of the development project within his or her view. As the process progresses, certain elements of the product are being locked down that impact the long-term commercial success, design attributes, manufacturability, inventory costs, marketing/sales, user experience, and clinical outcomes. Throughout the project, subject matter experts (e.g., the surgeons, manufacturing engineers, etc.) will provide input and support, but the development engineer is ultimately the one who must sift through all the information and recommendations to decide which to accept, modify, or reject. As such, the development engineer must be a jack-of-all-trades. Leading a development program should not be handled as if it is a democracy, but rather, as a benevolent dictatorship. The leader must listen, assess the situation, make a decision, and move on. Attempting to satisfy all parties will only cause delays.
There are techniques that can be used to help sort through the issues to attempt to make the best decisions. One technique is to note how many times the same concern is raised. If the issue is repeated by numerous surgeons and/or other advisors, it likely requires further exploration. If it is rarely stated or only by one surgeon, it may be safe to consider it a much lower priority. If the factor significantly impacts cost, however, determine how significantly it could impact the marketability of the product.
If a new, creative solution is conceived by a surgeon that seems to have originated from out of left field, it should not be automatically dismissed. Instead, challenge the surgeon to “sell” the idea to the rest of the design team. If he or she cannot earn their acceptance, it may be best to move on. This does not mean the concept was not worthy, but perhaps it needs to be sidelined from the current program and examined independently on its own merits at a later time or for a future generation of the product. Some creative solutions may seem like an idea that makes sense, but ultimately, must be considered within the scope definition for the project.
When having a design meeting, it is important to know the outcome ahead of time. Since design meetings can sometimes become confrontational, first addressing key topics individually with surgeons to understand their concerns and issues will provide a means to be better prepared for the full meeting and make it more productive. If there are controversial issues to be addressed, have one of the surgeon designers present them, which can also assist in making the meeting more productive.
After the concept for the product design has been finalized, enroll a second group of surgeons not part of the original design team to objectively review the new product concept. This can help ensure market acceptance and help identify issues that may have been overlooked. All members of the design team are too close to the project to objectively review the new product. While this review occurs late in the design process, it is still early enough to allow for modifications to be made relativity inexpensively.
Surgeon design teams have been and will continue to be a critical element for the advancement of healthcare in the development of new and innovative medical devices. Leading surgeon design teams is a skill a development engineer needs to hone and refine. It involves technical knowledge, psychology, business acumen, and most importantly, strong leadership attributes.
David C. Kelman, president of Kelman & Company Consulting LLC, is a licensed professional engineer who has managed and led design and development teams on three different continents for major orthopedic companies. He is a creative innovator whose broad scope of solutions has resulted in two unique startup businesses, commercialization of 40 product platforms, and 50 U.S. patents awarded. As a multifaceted problem solver, he incorporates technological and business sophistication across diverse environments, including product design/software/analytics/supply chain/technical marketing and sales. This unique mix of technical, engineering, and business expertise has resulted in successful business strategies, and the introduction of cutting-edge technologies with financial viability.