Designs on Implant Innovation, Part III

An orthopedic implant is only as good as its design. Many factors can influence the design of an implant or even a component within the device, including cost, materials, regulatory requirements and patient demographics. In the last decade, innovative surgical techniques and advances in technology have played an important role in shaping new implant designs that are now becoming the standard of care among orthopedic surgeons.

To gain some insight into the thought processes behind implant design and help identify the trends shaping the sector as well as the challenges currently facing companies, Orthopedic Design & Technology spoke to several industry professionals over the last few weeks.

They included:

•  Brian R. McLaughlin, former business development manager at Orchid Design, a division of Shelton, Conn.-based Orchid Orthopedic Solutions, a contract design and manufacturing firm serving the orthopedic, dental and cardiovascular markets.

•  Josh Sprague, vice president of Hoosier Inc., a full-service spinal contract manufacturing company based in Corona, Calif.

• Jeffrey Kapec, a principal and executive vice president of Tanaka Kapec Design Group Inc., a Norwalk, Conn.-based design consultancy.

• Steve Maguire, general manager at Orchid Design, a division of Shelton, Conn.-based Orchid Orthopedic Solutions, a contract design and manufacturing firm serving the orthopedic, dental and cardiovascular markets.

• Anand M. Vora, M.D., an orthopedic surgeon in Illinois who also teaches orthopaedic surgery at both Northwestern University Medical School and the University of Illinois Medical School. Dr. Vora also is a member of the American Academy of Orthopaedic Surgeons.

Editor’s note: This is the last of three installments of ODT’s roundtable discussion with these professionals about implant design.

ODT: What are some of the drivers of innovation in orthopedic implant design?
Josh Sprague: Minimally invasive and reduced surgery time are the two primary drivers that Hoosier sees. Minimally invasive often reduces patient pain and recovery, reduced surgery time means more surgeries are able to be performed and quite possibly performed more accurately. Cost often is a contributor to innovation too, but cost is usually looked at after the innovation.
Jeffrey Kapec: It’s a combination of biomaterials and the modeling capability of the new engineering tools. Prototyping—the ability to run prototypes quickly and experiment and test things faster, so the cycle time and development time is accelerated—also drives design innovation. Engineers are getting so much more support from bioscientists. This whole notion of growth factors stemming from stem cells—they’re discovering there are other growth factors outside of stem cells that we have within us even as we get older—these cells are being harnessed to assist in the fixation of the implant. It’s pretty remarkable stuff and it’s moving very quickly. Engineers in the past may have been interested in that, but now they’re almost becoming dependent on it for their design. So it’s a very interesting synthesis of specialties that are merging together to improve the design of implants.
Dr. Anand M. Vora: The drivers of innovation are when we see an opportunity for improvement. It comes from both ends—implant companies come to us very frequently and say, ‘We have this understanding now of titanium interaction and we’ve been able to look at how these metals work together and we think that by molding these two together we’ll be able to get you a better plate.’ Or, on the flip side, an orthopedic surgeon will go to a device company and say, ‘We’ve been using this ankle replacement and it has this advantage and this disadvantage, and we see an opportunity because we think we can create an implant that can provide advantages for our patients.’ The driver for innovation is the opportunity for improvement and it comes from both industry providing new devices for implants and mainly, orthopedic surgeons that are performing the procedures in both a private practice setting and an academic setting. Surgeons have an opportunity to think outside the box and look into new opportunities to try and make devices better.
Steve Maguire: The total cost of delivering positive clinical outcomes is one of the new drivers of innovation. This comes in many forms as it relates to design. The design of an implant leads to manufacturing cost, ease and time of surgery, patient recovery and rehab and ultimate longevity and outcome of the procedure.

ODT: Is it always necessary for surgeons and engineers to collaborate on implant designs? Why?
Vora: Nothing is always but I think that it’s very important that we work together. It’s very, very difficult for us to work in parallel paths. Generally, surgeons are not engineers and engineers are not surgeons, we don’t understand certain things that they’re able to do and vice versa. The great majority of time without a good orthopedic surgeon, a good engineer and a good company to work with, we wouldn’t make the advances that we’ve been able to make today.
Sprague: Absolutely. I’ve yet to hear of an implant that was designed without surgeon feedback on design. We’ve seen many new implants that work great in a lab or with a specific surgeon, but when tested with multiple surgeons that all have their own training and techniques that they prefer, the results are often mixed, resulting in design changes to accommodate the wide needs of a diverse surgeon talent.
Kapec: It has always been the case. Orthopedic surgeons tend to be mechanical engineers by nature. The whole concept of surgery is mechanical, so they really enjoy having a dialogue with engineers because they think along those lines. But for the orthopedic surgeon, whether during trauma surgery or implant surgery or reconstructive surgery—whatever it is, there are certain techniques and biological, physiological considerations they have to deal with. That is something the engineer is aware of, but doesn’t experience firsthand. There is a physicality of can I get in there, can I access that, can I see it, can I manipulate in those quarters. As industrial designers, we’re not performing the surgery, but we can observe it. We can see those issues, but we can’t always experience them first hand. The surgeon can visualize what he’s doing, what he might be able to do if something changes. That is where the creative dialogue occurs. Saying, ‘If I could do this, I would have this outcome. This would be cool. How could I do this?’ Or ‘If you can make me something that would do this for me it would give me more access. If you could put light at the tip of my instrument, I would be able to see in an area that I normally don’t have light. That gives me more visibility. I get more clarity in what I’m doing. Can you give me light down there? Can you give me visibility down there? Can you put an optic down there. Can you make that tip smaller and just as productive as the other larger tip?’

If we talk about implants, surgeons will visualize the challenge they’ve had with certain patients and they’ll be able to define those challenges and say to the engineer, ‘Can you overcome these for me?’ If you don’t have the orthopedic surgeon involved, you’re working with a half bushel of information. You don’t have the other component. For designers like us, what is really important to recognize is that you’ve got to get that input from more than one surgeon because you have a whole range of talents, skill levels, and approaches. You have to accommodate more than just one surgeon. When we design instruments, the challenge for us is to make sure we’ve accommodated the full spectrum as best we can and not just customize it for one particular approach.


That’s where it becomes very interesting for us. It’s like a potato peeler – you go into your kitchen, you watch people peel potatoes and there’s probably 25 different ways someone’s going to hold that potato peeler, all are somewhat similar, but there will be slightly different ways in which they hold the potato or whatever. My job is to understand these ranges and then see if I can do something that would allow every one of them get a good outcome. A simplification for sure, but it’s a good example. In the humble setting of the kitchen, people doing their day-to-day tasks establish certain patterns in the way they like to do things, the way they’ve been taught, the way their body allows them to do the work, the way their workspace is organized. All of these considerations form the constraints in why they do something in a certain way and once they establish it, they’re not as likely to change radically because they’ve got a comfort zone. Surgeons are kind of like that. If look at a surgeon who’s been training, he spends 12 years training, he finally has the technique down, and you’re going to tell him ‘Hey, don’t do it that way. I have a better way for you.’ He’ll say oh yeah? You have to respect that because developing that technique and perfecting it so it gives a good outcome each and every time is a very important consideration.
McLaughlin: Absolutely. Surgeons are the ones on the front line, dealing with diagnosing and treating. They see how technologies are able to address problems and make their patients’ lives better. Engineers are the ones that take the ideas from the surgeons and turn them into reality, but without close interaction, understanding and communication, those innovations would be more difficult to come by. At Orchid Design, we believe clinical interaction is critical which leads us to having our engineers participate in cadaver labs and clinical settings whenever possible.