Mark Crawford, Contributing Writer03.23.16
Orthopedics is a dynamic market that is still trying to find its equilibrium in the wake of a “perfect storm” of multiple factors, including the Great Recession, passage of the medical device tax, mergers and acquisitions in orthopedic companies, and increasing regulatory scrutiny and enforcement. These impacts and uncertainties have led to an overall decline in research and development (R&D) activity.
“Anyone who has attended the last few American Academy of Orthopaedic Surgeons or North American Spine Society meetings has likely noticed how the number and size of exhibitor booths are shrinking because of market compression—a reflection of reduced competition and innovation,” indicated Victoria Trafka, president and lead engineer for Engineering & Quality Solutions, a Colorado Springs, Colo.-based contract engineering and development company focused on orthopedic trauma and spine implants and surgical instruments.
Michelle Fleming, vice president and general manager for Spectrum Laboratories, Operating Room Disposables, a Los Angeles, Calif.-based manufacturer of products for the medical device, orthopedic, and pharmaceutical markets, agreed.
“Budgets have been slashed due to uncertain markets,” said Fleming. “The industry as a whole seems less likely now, more than ever before, to take risks.”
Most R&D budgets these days are fairly small—rarely more than 7 percent of sales, according to Tim Jeavons, founder of Lighthouse Orthopaedics, a Geneva, Switzerland-based consultancy that helps orthopedic companies design R&D strategies. Also to reduce costs, a few larger companies have centralized some aspects of research through innovation groups, as well as established R&D facilities in developing countries.
“When sales are flat, they budget more for R&D in order to have a healthy pipeline,” said Jeavons. “However, with launches that can now take up to two or three years, results from R&D spending don’t have as much immediate impact.”
Research and development—especially for brand-new products—is very expensive. If the product is especially innovative, unique, or complex, regulatory approval can also take longer, delaying product launches and adding cost. One way companies are controlling costs is by being innovative with existing products, which have already won approvals and have an extensive body of testing and supportive data behind them, as well as name recognition in the marketplace. Standard approaches for adding value to these products is finding ways to improve functionality and ease of use. Although making legacy products better and more functional might be easier than designing and manufacturing new products (less expensive as well), it is not necessarily easier to get U.S. Food and Drug Administration (FDA) approval for enhanced legacy products.
“In fact, the regulatory environment we work in has only become more cumbersome, as the rules continue to change,” said Fleming. “If, for example, we add a product to our family of already CE mark products, we still must complete the same burden of proof and demonstrate clinical feasibility—whether it is a brand new product or an extension of an already existing product.”
Even with the economic stressors the industry is facing, Trafka believes that quiet research has likely been taking place over the past several years, as the industry adjusts to the high-impact changes that have rocked the orthopedic market.
“I think we are now on the upswing, since many redundancies have been eliminated and company executives are more comfortable with the state of the market,” she said. “And of course, innovation always perseveres as surgeons and engineers find new ways to improve treatments.”
Technology Advances
Ah, innovation—coming up with the great ideas—is the fun part of research and development. To a large extent, designers and engineers can only be as innovative as their tools allow them to be. This is why medical device manufacturers (MDMs) are so excited about what seems like the limitless design possibilities that come with 3D printing. Equally exciting is how fast this technology is advancing—expanded capabilities, new materials, and larger product sizes. Printed layers can be as thin as a few microns. 3D printing is a good fit for certain orthopedic markets, such as spinal implants, which typically have complex geometries and low production volumes. It is also a suitable technology for rapid prototyping and production of patient-specific devices or implants. It is very likely that the materials, manufacturing precision, and affordability of 3D systems in the near future will make them a viable production method for a wide range orthopedic solutions that are customized to the patient. Because products and parts are made in a matter of hours instead of days (as well as eliminating the need for secondary steps and reducing material waste), 3D printing reduces costs and speeds delivery time to market (or the patient).
Advanced materials are also essential for orthopedic R&D efforts. Engineers continue to develop new surfaces for implants that extend longevity, biocompatibility, and performance, as well as minimize wear debris. For example, researchers are exploring vitamin E cross-linked polyethylenes as a potential implant material with enhanced resistance to wear and oxidation. Considerable R&D is also being invested in specialized coatings for implants, such as ultra-thin hydroxyapatite coatings that can be applied to a variety of materials, including metals, plastics, and polycarbons. Polyether ether ketone (PEEK) can be strengthened with additives such as carbon fiber. Variations of PEEK have been introduced that have enhanced physical characteristics that work well for specific spine applications.
An increasingly wide range of materials are also being developed for 3D printing, including plastics, metals, ceramics, and biomaterials. High-performance PEEK filaments are now available for 3D printers. As more multi-component devices are designed that require parts with sometimes vastly different materials, such as titanium, PEEK, cobalt chromium, tantalum, and nitinol, it becomes increasingly challenging to bind them together. This need has led to improvements in manufacturing techniques, such as laser welding.
“Although materials used in additive manufacturing may not be embraced as implantable,” said Jeff Randall, vice president of engineering for MRPC, a Butler, Wis.-based contract manufacturer of medical devices and components, “they are often sufficient to prove feasibility and, in some cases, demonstrate functionality in a time- and cost-effective manner. Watch for further adoption of additive manufacturing techniques as the materials and precision improve.”
More material suppliers are also offering long-term implantable materials. These are expensive on a per-gram basis; however, as the market gains experience and confidence in non-metallic implantable materials, pricing will become more competitive. A primary driver behind high material prices in this category is risk mitigation and anticipation of potential litigation.
“As the market gains confidence in these materials, the risk of litigation wanes, and competition exerts pressure to reduce prices,” Randall continued. “The ability to mold implantable components in their finished shape, or to mold a ‘near net shape’ and machine a couple of difficult-to-mold features, results in dramatic reductions in component costs.”
A fairly new design trend in orthopedic R&D is the use of computer simulation, such as finite element analysis (FEA), and motion simulation. These processes are especially valuable for testing the feasibility of complex devices that have multiple, high-precision components. Computer simulation allows for design iterations to be evaluated quickly and cost effectively.
Since the FDA released its guidance document in January 2014 on reporting computational modeling studies in medical device submissions, more engineers and regulatory personnel in the industry have accepted computational modeling as a legitimate and acceptable tool for evaluating a device. The guidance has bridged the gap between engineering/R&D, professionals, and reviewers, giving all parties a reference point for a successful submission.
“Although the guidance provides a foundation for reporting analysis approach and results in a scientific way, computer simulation is still an art form that requires a staggering number of factors to get meaningful and realistic results,” said Trafka. “I’ve worked on multiple projects where we used FEA in lieu of laboratory performance evaluation and earned regulatory clearance. It’s not an easy process, and we certainly had to prove the simulation results were credible, but FEA is a viable path for evaluation when the alternatives for mechanical testing are limited or nearly impossible.”
Regulatory Challenges
Remediation and compliance are major issues for today’s R&D departments. For example, quality and performance concerns for products such as hip replacements (debris and wear) have companies investing more time and money remediating their quality systems, design history files, and literature for these products. In addition, communication between the involved departments regarding these challenges can sometimes be muddled.
“Ultimately, this means that R&D is being tied up remediating old products, which typically slows down the start of new development programs,” said Jeavons.
As devices become more unique and complex, the regulatory pathway also becomes more complex, requiring more data and testing. The FDA is working toward speeding up the regulatory process, especially for new technologies, materials, and devices. For example, the agency is trying to shorten submission review times by providing more guidance documents and programs like Entrepreneurs-in-Residence, as well as participating in conferences such as the International Medical Device Regulators Forum. That said, the FDA is also understaffed, with investigators who are not always certain how to deal with disruptive technologies, such as 3D printing. But progress is being made—for example, EOS and Arcam have validated 3D processes that orthopedic companies have used to build implants, which ultimately received 510(k) approval from the FDA.
FDA regulations don’t shape R&D—they just define the regulatory pathway for devices to get to market. Regulatory requirements for custom devices, including those manufactured from additive manufacturing processes, continue to be evaluated. The FDA is trying to catch up with this rapidly growing sector of the orthopedic market, with a focus on regulating the testing, biocompatibility, and quality for custom devices.
“The possible future scenario of a surgeon conducting a patient scan, and then ordering a device off a 3D printer, is a good example of how technology ultimately shapes treatment, to which regulations must adapt,” said Trafka.
Why Partnerships Matter
In today’s orthopedic climate, partnerships and collaboration are paramount to R&D success. As companies stretch R&D budgets and resources, and the FDA tightens regulations and demands more accountability, MDMs and their supply-chain partners are working together to provide the best possible solutions and devices. MDMs want manufacturing partners that will take an active role in the development of new products or ideas, understand and honor intellectual property and confidentiality, and provide creativity and true problem-solving expertise.
“OEMs value partners that are committed to the success of the program and aren’t afraid to inject new ideas—perhaps from a different perspective—that may result in a better, more reliable, and more cost-effective solution that is easier to manufacture,” said Randall.
Another type of partnership is the strategic acquisition or merger.
“New technologies are being invented more by start-ups, with the aim of being purchased by a larger company,” said Jeavons. “Because very new technologies tend to be slow and expensive to develop, larger companies will often wait and see what is trending before buying or partnering with a company. R&D has also become more process driven, so it is important that the process be followed correctly and documented. As a result, larger companies tend to outsource more to design houses—the OEMs have the money, but not the head count, to run R&D projects.”
Partnerships are also critical for maximizing speed to market. While it was once common for development cycles to be counted in years, creative and dedicated partnerships between MDMs and vendors who share the same values and commitment can greatly shorten that development cycle (in some cases, only a few months). This is accomplished by rethinking development teams and roles, expediting prototype and evaluation efforts, partnering with external experts and companies, and even acquiring or licensing technology when needed.
“Partnering between an OEM and contract manufacturer results in improved efficiency and speed to market,” said Randall. “In these relationships, OEMs understand that the manufacturing cost of a product will likely change during development, and that they will share in the cost improvements we are able to recognize during the development phase, as well as efficiency gains during production. The most successful relationships are built on honesty, integrity, trust, transparency, and appreciation of the entire value proposition. In our most healthy relationships, we function as an extension of our partner’s team.”
Having a trusted partner with the same vision is also critical for getting the most bang out of the R&D buck. Because venture capital has declined for research, OEMs face increased competition for federal research money, which is also being cut back. This has reduced the rate of introduction of new groundbreaking products. With more researchers competing for fewer dollars, focused partnerships along the supply chain are essential for achieving cost efficiencies and staying on top of the latest science. For example, EQS has partnered with Empirical Testing Corporation to evaluate and gain deeper knowledge about the behavior and properties of newer materials and material combinations being introduced to the orthopedic market.
“This has helped us quantify and reliably predict product performance and stay ahead of some design and regulatory concerns that inevitably follow any new technology,” said Trafka. “The research data has also allowed my team to create more accurate FEA models and validate those results in the laboratory.”
Moving Forward
Orthopedic R&D is constantly being challenged by advances in technology and surgical techniques. OEMs are anxious to get new products to market as quickly as possible, both to maximize market position and help medical professionals improve patient outcomes. Often the design inspirations come from the surgeons who deal with the products on a daily basis, and have suggestions for improving functionality and ease of use.
“As a result, some OEMs are redesigning typically cumbersome products to create a more streamlined and user friendly experience,” Fleming said. “Some procedures and techniques have evolved to the point where they are now being held back in ways by first-generation tools. Sometimes the old way of thinking needs to be challenged, as many orthopedic devices are still not fully advanced and user friendly.”
For example, she notes, Spectrum Laboratories recently partnered with a company to design a shoulder distractor and disposable that allows the surgeon to control the patient’s limb from within the sterile field, reducing the need for circulating nurses to constantly monitor and assist the surgical team. This reduces cross communication and puts control into the surgeon’s hands.
Despite the constant pressure to keep up with changes in technology and design, the R&D landscape is not always overflowing with work. R&D companies need to be nimble to take advantage of opportunities that arise, and have the tools and expertise required to win the contract, as well as manage costs. Much of the innovation is coming from surgeon entrepreneurs or small- to medium-sized companies. OEMs (often based on communication with end users) also seek contract manufacturers with the right experience and analysis tools to determine the cause of unsatisfactory performance in an existing product and “design it out.” Even with these multiple needs from OEMs and end users, there is often no predictability as to when an opportunity will present itself, so R&D partners need to be ready.
“For example, you might discuss a project with a potential client and six to nine months later the prototype opportunity presents itself,” said William Beach, medical market segment manager for EPTAM Plastics, a Northfield, N.H.-based provider of precision-machined plastic products for the medical industry. “Or, in contrast, a call might come in for parts that are needed within one to two weeks or less. Regardless how much notification we get, it is always about speed and how fast we can get parts turned around, usually for a surgeon lab. The only predictable thing from the manufacturing side is that it’s unpredictable.”
R&D can be highly expensive and take a toll on budgets, especially for smaller companies. The amount of engineering, tool selection, and programming time are all major cost drivers that make prototypes expensive. That’s why it is important for MDMs to work closely with R&D partners up front to minimize cost and accelerate development.
For example, EQS recently had a client who was prepared to spend hundreds of thousands of dollars on full working prototypes of a complex device. The EQS team was able to simulate and verify the function before moving forward on costly physical parts. The motion simulation and FEA studies revealed that the design would not function as intended. The client opted for a major redesign, rather than wasting resources on a prototype that would fail.
“From a design standpoint, I prefer to fail early and often because it’s a quicker path to the optimum solution,” said Trafka. “Computer simulations are critical for identifying weaknesses early in the design process and pointing clients in the right direction for redesign. It saves time, money, and frustration.”
“Sometimes we have to remind ourselves that R&D stands for research and development,” added Randall. “The nature of R&D is that you are trying something new; there are no guarantees that your idea will work.”
Companies can be too conservative with their R&D approach. They need to be willing to fail or they will be left behind in the innovation race—which means slow erosion of market share, reduced profits, loss of talent, and damaged brand.
“It is important to understand that if you don’t fail from time to time, you’re not trying hard enough,” continued Randall. “Failure is just another term for ‘we haven’t succeeded yet.’ The only time you truly fail is when you stop trying.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.
“Anyone who has attended the last few American Academy of Orthopaedic Surgeons or North American Spine Society meetings has likely noticed how the number and size of exhibitor booths are shrinking because of market compression—a reflection of reduced competition and innovation,” indicated Victoria Trafka, president and lead engineer for Engineering & Quality Solutions, a Colorado Springs, Colo.-based contract engineering and development company focused on orthopedic trauma and spine implants and surgical instruments.
Michelle Fleming, vice president and general manager for Spectrum Laboratories, Operating Room Disposables, a Los Angeles, Calif.-based manufacturer of products for the medical device, orthopedic, and pharmaceutical markets, agreed.
“Budgets have been slashed due to uncertain markets,” said Fleming. “The industry as a whole seems less likely now, more than ever before, to take risks.”
Most R&D budgets these days are fairly small—rarely more than 7 percent of sales, according to Tim Jeavons, founder of Lighthouse Orthopaedics, a Geneva, Switzerland-based consultancy that helps orthopedic companies design R&D strategies. Also to reduce costs, a few larger companies have centralized some aspects of research through innovation groups, as well as established R&D facilities in developing countries.
“When sales are flat, they budget more for R&D in order to have a healthy pipeline,” said Jeavons. “However, with launches that can now take up to two or three years, results from R&D spending don’t have as much immediate impact.”
Research and development—especially for brand-new products—is very expensive. If the product is especially innovative, unique, or complex, regulatory approval can also take longer, delaying product launches and adding cost. One way companies are controlling costs is by being innovative with existing products, which have already won approvals and have an extensive body of testing and supportive data behind them, as well as name recognition in the marketplace. Standard approaches for adding value to these products is finding ways to improve functionality and ease of use. Although making legacy products better and more functional might be easier than designing and manufacturing new products (less expensive as well), it is not necessarily easier to get U.S. Food and Drug Administration (FDA) approval for enhanced legacy products.
“In fact, the regulatory environment we work in has only become more cumbersome, as the rules continue to change,” said Fleming. “If, for example, we add a product to our family of already CE mark products, we still must complete the same burden of proof and demonstrate clinical feasibility—whether it is a brand new product or an extension of an already existing product.”
Even with the economic stressors the industry is facing, Trafka believes that quiet research has likely been taking place over the past several years, as the industry adjusts to the high-impact changes that have rocked the orthopedic market.
“I think we are now on the upswing, since many redundancies have been eliminated and company executives are more comfortable with the state of the market,” she said. “And of course, innovation always perseveres as surgeons and engineers find new ways to improve treatments.”
Technology Advances
Ah, innovation—coming up with the great ideas—is the fun part of research and development. To a large extent, designers and engineers can only be as innovative as their tools allow them to be. This is why medical device manufacturers (MDMs) are so excited about what seems like the limitless design possibilities that come with 3D printing. Equally exciting is how fast this technology is advancing—expanded capabilities, new materials, and larger product sizes. Printed layers can be as thin as a few microns. 3D printing is a good fit for certain orthopedic markets, such as spinal implants, which typically have complex geometries and low production volumes. It is also a suitable technology for rapid prototyping and production of patient-specific devices or implants. It is very likely that the materials, manufacturing precision, and affordability of 3D systems in the near future will make them a viable production method for a wide range orthopedic solutions that are customized to the patient. Because products and parts are made in a matter of hours instead of days (as well as eliminating the need for secondary steps and reducing material waste), 3D printing reduces costs and speeds delivery time to market (or the patient).
Advanced materials are also essential for orthopedic R&D efforts. Engineers continue to develop new surfaces for implants that extend longevity, biocompatibility, and performance, as well as minimize wear debris. For example, researchers are exploring vitamin E cross-linked polyethylenes as a potential implant material with enhanced resistance to wear and oxidation. Considerable R&D is also being invested in specialized coatings for implants, such as ultra-thin hydroxyapatite coatings that can be applied to a variety of materials, including metals, plastics, and polycarbons. Polyether ether ketone (PEEK) can be strengthened with additives such as carbon fiber. Variations of PEEK have been introduced that have enhanced physical characteristics that work well for specific spine applications.
An increasingly wide range of materials are also being developed for 3D printing, including plastics, metals, ceramics, and biomaterials. High-performance PEEK filaments are now available for 3D printers. As more multi-component devices are designed that require parts with sometimes vastly different materials, such as titanium, PEEK, cobalt chromium, tantalum, and nitinol, it becomes increasingly challenging to bind them together. This need has led to improvements in manufacturing techniques, such as laser welding.
“Although materials used in additive manufacturing may not be embraced as implantable,” said Jeff Randall, vice president of engineering for MRPC, a Butler, Wis.-based contract manufacturer of medical devices and components, “they are often sufficient to prove feasibility and, in some cases, demonstrate functionality in a time- and cost-effective manner. Watch for further adoption of additive manufacturing techniques as the materials and precision improve.”
More material suppliers are also offering long-term implantable materials. These are expensive on a per-gram basis; however, as the market gains experience and confidence in non-metallic implantable materials, pricing will become more competitive. A primary driver behind high material prices in this category is risk mitigation and anticipation of potential litigation.
“As the market gains confidence in these materials, the risk of litigation wanes, and competition exerts pressure to reduce prices,” Randall continued. “The ability to mold implantable components in their finished shape, or to mold a ‘near net shape’ and machine a couple of difficult-to-mold features, results in dramatic reductions in component costs.”
A fairly new design trend in orthopedic R&D is the use of computer simulation, such as finite element analysis (FEA), and motion simulation. These processes are especially valuable for testing the feasibility of complex devices that have multiple, high-precision components. Computer simulation allows for design iterations to be evaluated quickly and cost effectively.
Since the FDA released its guidance document in January 2014 on reporting computational modeling studies in medical device submissions, more engineers and regulatory personnel in the industry have accepted computational modeling as a legitimate and acceptable tool for evaluating a device. The guidance has bridged the gap between engineering/R&D, professionals, and reviewers, giving all parties a reference point for a successful submission.
“Although the guidance provides a foundation for reporting analysis approach and results in a scientific way, computer simulation is still an art form that requires a staggering number of factors to get meaningful and realistic results,” said Trafka. “I’ve worked on multiple projects where we used FEA in lieu of laboratory performance evaluation and earned regulatory clearance. It’s not an easy process, and we certainly had to prove the simulation results were credible, but FEA is a viable path for evaluation when the alternatives for mechanical testing are limited or nearly impossible.”
Regulatory Challenges
Remediation and compliance are major issues for today’s R&D departments. For example, quality and performance concerns for products such as hip replacements (debris and wear) have companies investing more time and money remediating their quality systems, design history files, and literature for these products. In addition, communication between the involved departments regarding these challenges can sometimes be muddled.
“Ultimately, this means that R&D is being tied up remediating old products, which typically slows down the start of new development programs,” said Jeavons.
As devices become more unique and complex, the regulatory pathway also becomes more complex, requiring more data and testing. The FDA is working toward speeding up the regulatory process, especially for new technologies, materials, and devices. For example, the agency is trying to shorten submission review times by providing more guidance documents and programs like Entrepreneurs-in-Residence, as well as participating in conferences such as the International Medical Device Regulators Forum. That said, the FDA is also understaffed, with investigators who are not always certain how to deal with disruptive technologies, such as 3D printing. But progress is being made—for example, EOS and Arcam have validated 3D processes that orthopedic companies have used to build implants, which ultimately received 510(k) approval from the FDA.
FDA regulations don’t shape R&D—they just define the regulatory pathway for devices to get to market. Regulatory requirements for custom devices, including those manufactured from additive manufacturing processes, continue to be evaluated. The FDA is trying to catch up with this rapidly growing sector of the orthopedic market, with a focus on regulating the testing, biocompatibility, and quality for custom devices.
“The possible future scenario of a surgeon conducting a patient scan, and then ordering a device off a 3D printer, is a good example of how technology ultimately shapes treatment, to which regulations must adapt,” said Trafka.
Why Partnerships Matter
In today’s orthopedic climate, partnerships and collaboration are paramount to R&D success. As companies stretch R&D budgets and resources, and the FDA tightens regulations and demands more accountability, MDMs and their supply-chain partners are working together to provide the best possible solutions and devices. MDMs want manufacturing partners that will take an active role in the development of new products or ideas, understand and honor intellectual property and confidentiality, and provide creativity and true problem-solving expertise.
“OEMs value partners that are committed to the success of the program and aren’t afraid to inject new ideas—perhaps from a different perspective—that may result in a better, more reliable, and more cost-effective solution that is easier to manufacture,” said Randall.
Another type of partnership is the strategic acquisition or merger.
“New technologies are being invented more by start-ups, with the aim of being purchased by a larger company,” said Jeavons. “Because very new technologies tend to be slow and expensive to develop, larger companies will often wait and see what is trending before buying or partnering with a company. R&D has also become more process driven, so it is important that the process be followed correctly and documented. As a result, larger companies tend to outsource more to design houses—the OEMs have the money, but not the head count, to run R&D projects.”
Partnerships are also critical for maximizing speed to market. While it was once common for development cycles to be counted in years, creative and dedicated partnerships between MDMs and vendors who share the same values and commitment can greatly shorten that development cycle (in some cases, only a few months). This is accomplished by rethinking development teams and roles, expediting prototype and evaluation efforts, partnering with external experts and companies, and even acquiring or licensing technology when needed.
“Partnering between an OEM and contract manufacturer results in improved efficiency and speed to market,” said Randall. “In these relationships, OEMs understand that the manufacturing cost of a product will likely change during development, and that they will share in the cost improvements we are able to recognize during the development phase, as well as efficiency gains during production. The most successful relationships are built on honesty, integrity, trust, transparency, and appreciation of the entire value proposition. In our most healthy relationships, we function as an extension of our partner’s team.”
Having a trusted partner with the same vision is also critical for getting the most bang out of the R&D buck. Because venture capital has declined for research, OEMs face increased competition for federal research money, which is also being cut back. This has reduced the rate of introduction of new groundbreaking products. With more researchers competing for fewer dollars, focused partnerships along the supply chain are essential for achieving cost efficiencies and staying on top of the latest science. For example, EQS has partnered with Empirical Testing Corporation to evaluate and gain deeper knowledge about the behavior and properties of newer materials and material combinations being introduced to the orthopedic market.
“This has helped us quantify and reliably predict product performance and stay ahead of some design and regulatory concerns that inevitably follow any new technology,” said Trafka. “The research data has also allowed my team to create more accurate FEA models and validate those results in the laboratory.”
Moving Forward
Orthopedic R&D is constantly being challenged by advances in technology and surgical techniques. OEMs are anxious to get new products to market as quickly as possible, both to maximize market position and help medical professionals improve patient outcomes. Often the design inspirations come from the surgeons who deal with the products on a daily basis, and have suggestions for improving functionality and ease of use.
“As a result, some OEMs are redesigning typically cumbersome products to create a more streamlined and user friendly experience,” Fleming said. “Some procedures and techniques have evolved to the point where they are now being held back in ways by first-generation tools. Sometimes the old way of thinking needs to be challenged, as many orthopedic devices are still not fully advanced and user friendly.”
For example, she notes, Spectrum Laboratories recently partnered with a company to design a shoulder distractor and disposable that allows the surgeon to control the patient’s limb from within the sterile field, reducing the need for circulating nurses to constantly monitor and assist the surgical team. This reduces cross communication and puts control into the surgeon’s hands.
Despite the constant pressure to keep up with changes in technology and design, the R&D landscape is not always overflowing with work. R&D companies need to be nimble to take advantage of opportunities that arise, and have the tools and expertise required to win the contract, as well as manage costs. Much of the innovation is coming from surgeon entrepreneurs or small- to medium-sized companies. OEMs (often based on communication with end users) also seek contract manufacturers with the right experience and analysis tools to determine the cause of unsatisfactory performance in an existing product and “design it out.” Even with these multiple needs from OEMs and end users, there is often no predictability as to when an opportunity will present itself, so R&D partners need to be ready.
“For example, you might discuss a project with a potential client and six to nine months later the prototype opportunity presents itself,” said William Beach, medical market segment manager for EPTAM Plastics, a Northfield, N.H.-based provider of precision-machined plastic products for the medical industry. “Or, in contrast, a call might come in for parts that are needed within one to two weeks or less. Regardless how much notification we get, it is always about speed and how fast we can get parts turned around, usually for a surgeon lab. The only predictable thing from the manufacturing side is that it’s unpredictable.”
R&D can be highly expensive and take a toll on budgets, especially for smaller companies. The amount of engineering, tool selection, and programming time are all major cost drivers that make prototypes expensive. That’s why it is important for MDMs to work closely with R&D partners up front to minimize cost and accelerate development.
For example, EQS recently had a client who was prepared to spend hundreds of thousands of dollars on full working prototypes of a complex device. The EQS team was able to simulate and verify the function before moving forward on costly physical parts. The motion simulation and FEA studies revealed that the design would not function as intended. The client opted for a major redesign, rather than wasting resources on a prototype that would fail.
“From a design standpoint, I prefer to fail early and often because it’s a quicker path to the optimum solution,” said Trafka. “Computer simulations are critical for identifying weaknesses early in the design process and pointing clients in the right direction for redesign. It saves time, money, and frustration.”
“Sometimes we have to remind ourselves that R&D stands for research and development,” added Randall. “The nature of R&D is that you are trying something new; there are no guarantees that your idea will work.”
Companies can be too conservative with their R&D approach. They need to be willing to fail or they will be left behind in the innovation race—which means slow erosion of market share, reduced profits, loss of talent, and damaged brand.
“It is important to understand that if you don’t fail from time to time, you’re not trying hard enough,” continued Randall. “Failure is just another term for ‘we haven’t succeeded yet.’ The only time you truly fail is when you stop trying.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@charter.net.