04.04.08
7 Factors in Product Design and Development
What does it take to get a new product to the market today? Maybe more than you think.
By Jennifer Whitney
Editor
Even as designers get creative, they always remain mindful of cost and regulatory issues. Photo courtesy of Orchid Design. |
The angst that can ensue in a writer’s mind is nothing compared to the pressure orthopedic R&D professionals face. If a writer stumbles on one article, it’s doubtful the entire magazine will crumble overnight. A poorly designed orthopedic device, however, quickly can erode a manufacturer’s reputation for innovation and quality, zap potential for future profits and even cause a company’s downfall in the form of class action lawsuits.
Indeed, there are many considerations a device maker must factor into its design efforts, and some present more challenges than others. Following is a look at the steps orthopedic R&D teams follow in getting a product made, and the issues they must take into account along the way.
Brainstorming: Research, Then Develop
Brainstorming may not be the most innovative step in the concepting process, but it may just be what produces an innovative concept. Since creativity counts at this phase of the R&D cycle, it’s easy to see why it can be one of the more exciting tasks for engineers today.
“I am focused on creating an environment in which talented R&D people feel they’re having fun and can accomplish something,” said Rob Ball, vice president of global research and development for Tornier, an Edina, MN-based developer of extremities products. “Philosophically, I’m really opposed to a more traditional organization where marketing goes out and does research and tells us what’s needed. I force my R&D group to go out into the field and learn for themselves and draw their own data to come up with conclusions as to what the market needs. I believe it’s the best way for an engineer to create a product that satisfies the requirements of the market. When you create a design control system that tells engineers to focus on certain procedures, it sometimes stifles creativity and they’re not innovating. That’s not what any engineer wants.”
In general, at the brainstorming stage of the R&D process, product developers are looking to clearly understand and crystallize market needs that a future device is going to fulfill. Steve Maguire, general manager of Orchid Design in Shelton, CT, is no stranger to exploring these issues for his clients. The first step, he said, is having the right number of people involved in brainstorming exercises. The optimal group, he said, contains about five or six people. “Two is too few, 10 too many,” he added.
By the same token, it’s important to have a good mix of people in terms of expertise. Some of his staff are engineers, while others are more clinically or manufacturing oriented. And not all of Orchid’s engineers have spent their careers focusing on orthopedics because, according to Maguire, it’s important to have alternative perspectives on new product development.
“We don’t want just a group of engineers who’ve only done orthopedics,” he explained. “Sometimes that can be a problem at the orthopedic companies. Their background is always what was, not necessarily what could be.”
As a team, his design group starts not by immediately identifying solutions but, instead, simply truly understanding the problems in the market. Once this is accomplished, the group begins brainstorming concepts that address the problems. At this point, quantity of concepts is more important than quality. After everyone goes off to work on their ideas individually, the group will reconvene and develop perhaps 25 potential ideas. Sometimes, he said, one idea coupled with another one can result in a very innovative solution.
After a concept is selected, endless questions must be satisfactorily answered, such as: Does the product fit in the company’s strategic roadmap? Have competitors already beat us to the punch? Will the millions of dollars spent in development be worth the effort when the product reaches the market?
If the product appears to be worth developing, the next group of experts—end users—is brought on board to evaluate the product’s design and utility.
Considering the Surgeon’s Viewpoint
If it’s true that the final product often isn’t the brainchild of a sole inventor but, rather, a culmination of various engineers’ ideas, then it’s no surprise that designers often seek out a diverse group of surgeons to evaluate and provide input on a product concept.
“There are surgeons who can articulate a need and describe what they see in their offices every day and what they need to fix that challenge. But those aren’t always the same individuals who can help you with instrument refinement. You have to have a diverse team. You have to have a thought leader on where treatment is going and one that is good from a carpentry perspective,” explained Keith Valentine, president and chief operating officer of NuVasive, Inc., a spinal developer based in San Diego, CA.
Along with gathering different viewpoints on the finer aspects of a product’s features and utility, the diversity among consulting surgeons helps to ensure that a product won’t be evaluated only by the upper echelon of physicians and result in a device that is too sophisticated for the average end user.
“If a surgical procedure only can be done effectively by 5% of the surgeons out there, then that’s a problem,” Maguire noted. “If you draw corollaries, we all drive cars—some race car drivers are at the top of their game and can make a car do anything they want, but then there’s you and me, who can’t do that. It’s perhaps a silly example, but it’s similar in the surgeon community. We have to be careful not to design around the 5% because they can make anything work, and when you design products around them and try to translate that into the 95% that aren’t as well equipped, the product still has to work.”
Ultimately, designers tap into surgeons’ expertise to refine features to create a product that is distinguishable from others in the market. After all, at the end of the day, it’s the surgeon’s perception of how the product functions—and how easy it is to use in the operating room—that will drive physician adoption.
“If you take an idea from the surgeon and let your engineer finish it without closing the loop or carefully including surgeon input, you can get into trouble,” said John Pepper, principal of Creative Orthopaedics LLC, a design and development firm in Cheshire, CT. “Some companies do this, but I’ve encountered instruments that may have overlooked anatomical or ergonomic considerations.”
Of course, it almost goes without saying that recent well-publicized government investigations into the role of consulting surgeons in product development has made many companies more carefully evaluate how they interact with end users. However, as Maguire noted, “The important thing to recognize is that innovation can’t take place without surgeons. Unfortunately, we can’t go to patients and get their input. The surgeon is the patient advocate.”
A Surgeon’s Wish List: Minimally Invasive
The experts agree: For all the hype about advances in minimally invasive surgery (MIS), don’t expect interest to wane anytime soon. The industry has only just begun to tap into the potential of this market. The knowledge that large incisions take longer to heal, may require longer hospital stays and pose greater risk of complications and higher costs remains good motivation for product developers to approach traditional surgical procedures and create less-invasive means to perform them.
The CoverLoc Volar Plate, used for distal radius fractures, is one example of the growing number of options for extremities procedures. Photo courtesy of Tornier. |
“The reality is that a lot of times you are destroying so much tissue to get to the area you want to correct, it can create other problems,” Valentine explained. “We’re evaluating how to do the procedure in a more productive and less-invasive way.”
Therefore, new surgical instruments often are designed to replicate what hands formerly did in traditional invasive procedures. Pepper, who has worked with various spine product developers, recalled one project in which the consulting surgeon told Pepper’s group that spine surgery is difficult enough and, thus, new designs need to help simplify the procedure as everything—from the incision and resulting limited view of internal anatomy to the instruments used—gets smaller and more complex.
And with good reason. “Sometimes we forget that a patient’s life is on the line—and a physician’s career can be on the line, too. They [surgeons] think, ‘If I make a mistake, I’m done.’ That’s a lot of pressure. Therefore, bad products are going to stand out and not be used,” Pepper said.
Form and Function Count—as Do Aesthetics
Clearly, design experts are aware of what surgeons want when they perform a procedure, whether it is invasive or not. Easy, fast and repeatable is one mantra for device developers today. Intuitive is another.
“Even if it’s a simple procedure, it’s harder than it looks,” Pepper said. He should know, given that he has a background as both a mechanical and biomechanical engineer and performed various surgical procedures on animals when he was in graduate school. “Some of the factors surgeons have to deal with are all the blood and fluids, the gloves on their hands and positioning issues. Having done that myself, I try to really listen to their struggles and then work from the patient back. What do we need to do with the bone, the pins, the muscles? How will the implant and instruments impact that directly? And how will these things be controlled by the surgeon? I make the modeling from there.”
Thanks to advancements in manufacturing equipment and techniques, modern surgical instruments tend to less boxy and square, and they have better ergonomic features than prior generations. The benefits of injection molding are apparent, as products such as ratcheting drivers now often come with molded silicone handles to offer surgeons sculpted parts that feel better in the hand.
“The wise marketing and R&D leaders are putting more attention on function. It’s easier to sell a system that looks good than one that looks like it came out of the ’70s,” Pepper said.
Of course, it doesn’t matter how pretty a device looks if it doesn’t do the job well—or, just as bad, makes the job difficult to accomplish.
“The best products are those that are simple and elegant. We really stay clear of products with lots of pieces because they just are not that attractive to a surgeon. We focus on making them as simple and intuitive as possible,” Ball of Tornier concluded.
New Materials Offer New Design Opportunities
Aesthetics may present branding opportunities in terms of catching a surgeon’s eye, but it’s doubtful a patient cares too much about how an implant will look inside his or her body. All that matters is that it is safe, effective and can last a long time so a revision surgery isn’t on the agenda in the future.
Therefore, while the implant market today may be saturated with better products than ever seen in the past, the industry continues to ensure that new designs address lingering issues related to implant wear, fatigue, longevity and even radiopacity (for imaging purposes). One of the ways product designers are achieving this is through the use of new materials.
Although metal won’t be going anywhere anytime soon, non-metallic options such as PEEK polymer or carbon fiber materials are finding their way into both large joints and spine products. And rough surfaces are giving way to highly porous implant structures that help promote bone in-growth.
The future of innovation, however, appears to be implants designed to work with biologic agents.
“We’re going to start seeing studies that may change the way implants are designed if they’re going to be used with another treatment,” Pepper predicted. “A lot of surgeons will put BMP [bone morphogenic protein] in with a multitude of devices. The question now is, how can we optimize implants for use with BMPs?”
Tornier is looking to answer that question as it explores new ways to address what Ball believes are “significant unmet needs” with regard to loosening rates, wound-related complications and other factors. “Surgeons are thirsty for some solution through what they don’t believe they’ll get with metal and plastic products. That’s a common conversation,” he said. “Surgeons almost universally believe their job will be made more simple through the use of biologics in the future.”
Of course, going down that path will not be without its challenges to product developers. With little clinical data available about these products to date, companies will have to figure out how to best leverage use of biologics while proving they are safe and effective.
Weighing Time and Cost Against Innovation
The proof is in the pudding: If you don’t take the time to ensure a design will be safe and effective, chances are you are going to pay for it later down the line in the form of slow sales or no reimbursement (or both), or even liability suits when a patient’s safety is compromised. That said, lead time always remains an issue. So, ultimately, product developers must strike a balance. They want to get to market quickly but can’t cut corners along the way. As such, designers must examine all these factors early in the design process to ensure that proceeding with an idea truly will pay off.
“Cost is a very strong consideration,” Valentine said. “It plays heavily in our decision process. What is the reimbursement avenue for us? If there is reimbursement potential, it leads to a certain pathway of analysis. If not, will there be potential for reimbursement by the time a clinical trial is completed, or [alternatively] should you design your trial to get reimbursement?”
No longer is it just enough to get through the FDA’s (or other regulatory body’s) approval process. “Today, it’s about economics and reimbursement,” Maguire said. “It’s not just a matter of, is it approved but also, does it make sense economically?”
One way to keep costs low is to carefully assess very early in development all the possible risks of undertaking a new project. If it makes sense to proceed with developing a product idea, the next step is to map out a timeline for getting through each stage of development until launch. In addition, orthopedic OEMs have to compare the benefits of performing all the steps in-house or selecting strategic outside partners to accomplish everything on a “to-do” list.
NuVasive, for example, has its own rapid prototyping center and fully equipped in-house testing laboratory. “To do cyclic loading [for example] is invaluable in helping to cut down early development time,” Valentine said, noting that the company also has a six-station cadaver lab. With all of these functions under one roof, he added, “We can quickly develop prototypes and have a surgeon assisting on a cadaver to quickly give feedback on what subtle changes need to be made so we can get to launch as quickly as possible.”
IP and Patent Issues
The MaXcess Retractor with Blade Rotation Spreader, used in spine procedures, is an example of the products that designers are creating to help surgeons facilitate minimally disruptive approaches to conventional techniques. Photo courtesy of NuVasive. |
“The whole IP [intellectual property] world is an integral part of product development,” said Maguire. “There are situations where companies have a great idea; however, if they’re potentially infringing on someone’s patent the idea may not be executable, and they need help to ensure they aren’t doing so. Our engineers have to be more trained in understanding patent claims, doing searches and being familiar with the overall process of doing claims and understanding the patent landscape. We cannot replace patent attorneys, but we need to be smart enough to work with them.”
Companies weren’t quite as concerned with IP and patent issues a decade ago, experts said, but with higher expectations on orthopedic manufacturers and shrinking timelines, ample concern about infringement must be balanced with pressures to innovate. It’s not easy to achieve this balance, though.
“You have a bit of a difficult situation because you can say this idea is going to make a lot of money, but you don’t know that for sure. The question becomes, do you want to spend the time and money for a patent search? You don’t always know what’s out there,” Pepper said.
NuVasive has weighed the risks and, from the time of the company’s inception, the course of action was clear. “One thing we did early on in our existence—which is unusual for startups—is we brought on board our own chief patent counsel. It is critical on two fronts: to protect your own technology and get the appropriate reviews of the patent landscape,” Valentine said.
There’s an old saying that there is no such thing as an original idea, and it appears orthopedic manufacturers are moving forward with plans to ensure—at the very least—that nobody else already has patented their idea. That doesn’t mean it’s easy, even if it’s a smart business practice.
“When you combine IP with reimbursement and regulatory and clinical challenges while improving healthcare, all these constraints make it challenging,” Maguire acknowledged.
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With so many steps to take and so many considerations to examine when taking an idea and turning it into a new product, it’s a wonder how creators—whether a writer or a design engineer—make it to the finish line. But the big payoff, if it comes, is so worth it.