Christopher Delporte, Editorial Director, Medical Devices04.02.14
The orthopedic business—as is the case with most other medical device sectors—is caught in the push and pull of a number of different market forces. Companies are learning to navigate the demands of a changing healthcare environment in the United States (think universal healthcare and the medical device tax) as well as managing the opportunity emerging markets promise (BRIC by BRIC). Add to those keeping pace with clinical demands and material advancements, and orthopedic companies and their manufacturing partners have a lot on their plates. For better or worse, one of the first departments impacted by all of this is research and development (R&D). R&D pros are the folks medtech executives call on to be catch-all problem solvers—from taking the lead on product design and new market exploration to developing manufacturing and cost-containment solutions.
To help Orthopedic Design & Technology explore some of the issues currently swirling in orthopedic R&D circles, we chatted with the following industry experts:
1. Orthopedic Design & Technology: How has R&D in the orthopedic industry changed over the last few years from your perspective? What’s driving the change?
Emily Ho: When I first started in orthopedics about 10 years ago, many implants were intended for treating back pain. Now we’re seeing a lot of tissue-engineered biological scaffolds and injectable products. Currently, there are two key forces in orthopedics—first, anything that’s driving minimally invasive procedures to repair bone defects. This could include injectable bone materials. Secondly, companies are launching products to repair soft tissue such as cartilage and tendons. The cost of hospital stays are an influencing factor in promoting minimally invasive surgery, along with addressing how quickly a patient can recover from a procedure without incurring additional pain. In orthopedics, a lot is driven by the pain level or pain score, and how fast a patient can return to work. It’s not as much about the treatment as it is about how quickly the device can restore or improve a
patient’s quality of life.
Jim Schultz: Today’s R&D environment is experiencing greater scrutiny by management to bring products to market that have measurable value and sustained benefits. The trend in the dominant U.S. market is moving toward a “socialized medicine” model with reimbursement limits and spiraling hospital costs making OEMs rethink what the right products and instrument sets are going forward. Business as usual and in many cases using the same suppliers will not sustain margins nor grow market share and emerging market growth isn’t fast enough to offset margin erosion in established markets. The drive to save costs and the need to accelerate new products to market while working in a highly regulated environment is straining every step of the product development process and requiring some new thinking.
For example, if you want to convert costly reusable surgical instruments to single use you want to collaborate with a firm that understands injection modeling, plastics and merging of stainless steel materials and has a track record fielding medical disposables and not just impose the requirement on a contract manufacturer or an existing reusable instrument supplier. That approach will result in a lot of effort that will yield modest incremental cost savings and a “Band-Aid” answer. The best solution is one that embraces a different mindset and methodology that can be game-changing and put up barriers to competition.
Mike Carroll: Since costs are lower, R&D activities are becoming more aimed at cost-effective solutions, not just for implants, but for surgical procedures. New technology has become more difficult to introduce because of cost constraints and the burden of proof required by healthcare institutions, physicians and patients. As a result, the introduction of new technology related to implants will slow.
Peter Bayer: We’re seeing a lot more activity internationally. The growth of a middle class in China and India especially is driving much of this change, generating increased demand for orthopedic products in these markets. We’ve also seen a trend toward single-use devices. The cost of providing multiple, large reusable instrument sets to the field is becoming increasingly difficult for OEMs to bear. Hospitals are also starting to appreciate the simplicity of products that are delivered with everything required for the procedure in a single peel-pack. They do not have to manage, store and reprocess large instrument sets, and single-use products lower cross-contamination risks.
Ken Gall: Surgeons are demanding surgical solutions that not only serve a mechanical or structural function but also promote biologic healing and/or integration. This is driving companies to develop implants that are bio-active or release biologics. MedShape has begun to meet this demand through its recent development of a new biomaterial platform, a surface-porous PEEK (polyetheretherketone) called Scoria. Scoria was developed out of Georgia Tech (the George Institute of Technology in Atlanta) by a group of scientists and engineers. MedShape recognized the impact a porous PEEK material could have in the orthopedic industry and is licensing the technology.
2. ODT: What kinds of R&D challenges (or opportunities) are medical device makers facing and how do you respond? If you’re an OEM, are all of your R&D efforts internal?
Schultz: Driving out costs is crucial and that must be achieved on more than an incremental basis. Product life-cycle costs are being inspected like never before and cost centers are being eliminated. Some ortho/spine OEMs have instituted CEO initiatives requiring division leaders and corporate supply chain leaders to look across the enterprise and implement change that will make the company leaner and more efficient as fast as possible.
Simplifying the number of SKUs (stock-keeping units), for example, and using common tools across multiple platforms and moving to disposable instrumentation is the way of the future. We are collaborating with ortho/spine OEMs to help make them more competitive by driving out costs that can save them over $400 per procedure or $1 billion per year while concurrently bringing them value that can be translated to their customers, i.e. the hospital and ASCs (ambulatory surgery centers).
Sustained benefits like guaranteed sterile pack instruments and kits ready for use, always-accurate torque for implant fixation and reduced inventory management and sterile processing costs.
Carroll: For newer or start-up companies, the challenge is finding good talent and retaining that talent. In addition, good market research and strategic planning is critical to focus R&D efforts. We have a mix of both internal and external R&D, with the most being internal.
Ho: In the orthopedics world, the challenge is two-fold. There is the issue of acceptance of new materials in a barely penetrated market due to concern about adverse side effects; clinical requirements involve much more time. The other challenge is design evolution and how it will dramatically change existing procedures. For example, a procedure that involves repairing a screw for a hip joint is completely different and therefore requires a surgeon to learn additional skills, along with how to use the new technology. The biggest opportunity here involves incremental change. In addition, since surgeons are less willing to accept new materials, we have even more to prove in demonstrating that a new material can provide benefits over existing materials in use—for example, that it reduces time, money and resources. From our perspective, we demonstrate the benefits of the material from a manufacturing and compliance standpoint, along with how much easier it will be for surgeons to use our material during a surgical procedure. It’s important for a material to shorten surgery time while ensuring that it reduces inflammation or rejection risk post-surgery. These two points provide a financial benefit as well, as they reduce the occurrence of adverse events and secondary surgery.
Bayer: There have been two major challenges facing the orthopedics industry. The first is a continued push to reduce cost. Cost control is a key driver on almost all our projects. The second is the increasing complexity of the regulatory environment. We help our clients with cost issues by addressing them at the very start of the project. We’ll ask them to define cost and volume targets based on their business requirements. What does the manufacturing cost have to be for the business and the product to be successful? Understanding this critical requirement early on allows us to design the product to the required cost, using appropriate manufacturing processes.
We offer regulatory affairs consulting services to our clients to help them navigate the regulatory requirements for their products. Just as it is important to understand cost requirements as early as possible, it is equally important to develop a regulatory strategy at the beginning of a project. Our team will help a client develop a regulatory plan for the product based on the countries in which they intend to market the product. They will also help identify appropriate predicates and develop test plans tailored to the device classification and markets.
Gall: We have our own team of R&D engineers and scientists that work together to conceive, design, and manufacture our products. Our biggest challenge is being able to pursue all of the ideas we have taken up to proof of concept. Projects are prioritized by a combination of things including the importance of the clinical need being met, market opportunity, and ease of manufacturability and commercialization.
3. ODT: How do clinical and technical considerations converge in the research and development process, and how are they reconciled?
Carroll: Clinical considerations are always the basis for technical solutions in medical device research and development. The clinical and technical considerations crystallize, or are reconciled, into concepts for new products after the clinical need is communicated to the R&D engineers and scientists. After this, design inputs are finalized and the new product is developed. Manufacturing feasibility from a technical and cost perspective plays a large role in the complexity and duration of the R&D process as well.
Ho: Customers don’t always know what they want. In most cases, they give us a wish-list of clinical considerations. From an R&D point of view, we need to translate this into a technical requirement. For example, they might say they want their implant to be as strong as possible. However, you don’t want an implant to be as strong as possible, because the body cannot handle too strong of a product. The part of the body that has to work with this component or implant will undergo excess stress, which can lead to failure.
We also help customers understand the technical details of our products. If we’re working with a resorbable material, a customer might not understand that when you implant a resorbable to repair damage, you’re asking the patient’s body to heal naturally. We have to educate them about how our material is beneficial to the healing process—how it reduces inflammation and scar tissue, for example. From an R&D perspective, we make the connection between what the customers really want, what we can do, and how our quality system comes into play.
We need to ensure we have a standard process to make the product, so we help our customers understand any potential limitations and how we will ultimately deliver a consistent product with their desired properties.
Bayer: We view our projects as opportunities to bring our technical expertise together with the clinical expertise of consulting surgeons to provide optimal, clinically relevant solutions. There is no substitute for getting and incorporating user feedback throughout the development process. We also recognize the importance of getting feedback from multiple users. Certainly there are times when feedback from users conflicts with that from other users and with technical requirements. We find it helpful to work with users in a group setting so that the fundamental basis of a conflict is completely understood. Once conflicting requirements are understood we can work to find a suitable balance between the conflicting forces or design out the conflict to eliminate it.
Gall: There are always clinical needs that are difficult to satisfy and engineering solutions that serve no clinical need. But sometimes it is helpful to work in these extreme realms to make new discoveries. However, for the most part, we iterate on designs closely back and forth between engineers and surgeons to converge on a design that works and has clinical benefit.
Schultz: Any new product or instrument must pass the litmus test—it must provide clinical and economic value. If not, companies are asking why and how they can migrate to the position they need to be in to achieve company goals.
4. ODT: From which sectors of the orthopedic market are you seeing most of your business, and do those sectors come with unique requirements?
Schultz: We are seeing demand across the ortho and spine segments almost equally. Requirements are essentially the same. We must develop and field robust single-procedure solutions that can add measurable value to both the OEM and end-user. Driving out costs and providing competitive advantage in both established and emerging markets is critical. We must be agile, adaptive and execute.
Ho: In orthopedics, there’s always a desire for either addressing mechanical properties or promoting tissue regeneration. If I’m wearing my biomaterials hat, I can tell you about materials we offer that have limited mechanical properties but can encourage tissue regeneration. Such a material would be used for repairing bone fractures and could be in the form of a putty or plug. Our biomedical textiles processes allow us to improve the mechanical properties of biomaterials with less mass. Through knitting, braiding or weaving, we can provide mechanical properties that include stiffness, tensile strength and elasticity. Many biomedical textile devices we produce are made with shape-memory materials that can expand and change shape once implanted. This particular property promotes minimally invasive surgery, because a surgeon only needs to cut a small hole through which to implant the product, as it expands inside the body.
For example, using textile-forming processes, we can create a component that uses a smaller amount of shape-memory metal and combine it with a polymeric textile structure. Such components can be trained to change shape at body temperature, which allows the surgeon to squeeze it into a small area without making a large incision, as it reshapes into a larger structure inside the body.
Also, components with tailored properties that mimic natural soft tissue can be produced using biomedical textiles. Employing knitting, braiding and weaving processes, we can create a component that provides both flexibility and strength that is suitable for cartilage repair.
Bayer: We’re seeing a lot of activity in large joints. Typically, the focus is on developing quality, cost-effective products and not necessarily on developing products introducing a lot of innovation. There is a definite trend towards providing quality, generic, low-risk solutions. Large-joint product design does require expertise that differs from that needed, for example, in extremities or trauma. The design team in our Memphis facility has the large-joint expertise and experience that has led to many successful projects.
Carroll: Hips. Unique R&D requirements for this include a shift from traditional implant product-focused approach to that which is more focused on the surgical procedure. So the engineers we typically have a hard time finding are those who not only know the anatomy, but just as importantly have in-depth knowledge of instrument and mechanism design. Implant design experience is sometimes a less important job requirement than instrument design experience.
Gall: With the recent release of the Eclipse soft-tissue anchor and ExoShape ACL femoral fixation device, we are seeing outstanding growth in the foot/ankle and sports medicine sectors. Both markets require devices that simplify the procedure and allow for an anatomic repair. We believe we have addressed market demands with these new product offerings.
5. ODT: How are your R&D processes, practices and technologies updated or altered to respond to market trends, clinical needs and/or different customer requirements?
Schultz: We’re investing in people, key infrastructure and resources that position us to effectively react to the avalanche of pent up demand across the marketplace to eliminate cost centers, convert traditional instruments and surgical kits, where practical, to single use and modify or scrap business models that no longer scale. Serving as a collaborative partner with our OEM customers brings innovative solutions to them that can be translated into new customers in new markets and also sustained margins at home.
Ho: When seeking FDA (U.S. Food and Drug Administration) approval, companies must undergo either the 510(k) or PMA (premarket application) process. They need to have design controls. Since we’re not a device company, we’re technically not required to have design controls, but that doesn’t mean we don’t provide the documentation required. Our internal integrated product development process (IPDP) mimics the different phases in design control. We have two feasibility phases that drive design freeze, after which we conduct process optimization qualification, followed by process qualification. Our IPDP gives us a high confidence that we’re reducing risk and ensuring consistency.
The Lean process also helps us reduce ultimate product cost for our customers. When the customer needs to submit their product for regulatory approval, we can provide them with the validated statistical data required, while also helping them build the product’s design history file and ensuring traceability.
Bayer: We completely revamped our product development process last year to leverage everything we’ve learned since we opened our doors nine years ago. A key feature of the updated process is the integration of design transfer (DT) activities throughout the entire project. Rather than leave DT to the very end, we’ve pushed DT activities as far upstream in the process as possible. As an example, we start selecting materials and manufacturing processes in the concept phase, so that our concepts move quickly towards manufacturability and cost effectiveness. The integration of DT activities throughout the project provides the client with a smooth, quick and cost effective transfer of the product into manufacturing. Our approach minimizes the costly delays and surprises that often occur when DT is left to the very end of the project. We’ve also added a custom-built test cell for evaluating cutting instruments and screws. This new test cell allows us to provide quantitative information to the client on cutting instrument performance in terms of speed and efficiency. The cell also allows us to perform ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws) screw testing, either on an investigational basis or for formal verification testing.
Gall: We have not altered our core processes and practices very much in response to clinical needs. However, the constant push for lower-cost devices has required us to consider out-of-the-box, cost-effective manufacturing that still provides high-quality products. We often employ injection molding to manufacture our implants and instrument parts as a means to help alleviate costs.
Carroll: All processes are updated from time to time to keep pace with the changing regulatory environment. Since some trends require different levels of scrutiny by regulatory bodies, specifically those related to an increase in clinical assessment, requirements for new products and product development must focus on a smaller number of projects. Many novel technologies require the industry to develop new assessment methodologies and propose these to regulatory bodies much sooner in the R&D process than done in the past.
To help Orthopedic Design & Technology explore some of the issues currently swirling in orthopedic R&D circles, we chatted with the following industry experts:
- Peter Bayer, business development manager for Orchid Design, which has offices in Shelton, Conn., and Memphis, Tenn. It is a division of Holt, Mich.-based Orchid Orthopedics, a medical device contract design and manufacturing company that offers services including design, forging, casting, machining, plastics technologies and implant bone in-growth coatings, as well as quality and regulatory consulting.
- Mike Carroll is vice president of research and development at Arlington, Tenn.-based MicroPort Orthopedics, which develops orthopedic reconstruction products. MicroPort Scientific recently purchased the OrthoRecon business of Wright Medical Group, now branded as MicroPort Orthopedics, specializing in minimally invasive and other emerging medical technologies. The company recently launched its Implant Partners subsidiary, which collaborates with surgeons, payers and hospitals to provide primary joint replacement solutions at steeply discounted prices via a “rep replacement“ business model.
- Ken Gall, Ph.D., chief technology officer of Atlanta, Ga.-based MedShape Inc., a privately held medical device company that develops surgical solutions that use patented material technologies to address the increasing demand for improved sports medicine, joint fusion and musculoskeletal trauma products.
- Emily Ho, Ph.D., manager, product development, at Perkasie, Pa.-based Secant Medical Inc., which provides advanced biomaterials and biomedical textile structures to the medical device industry. The company partners with medical device OEMs to design, develop, and manufacture high-performance biomedical structures for cardiovascular, general surgery, neurovascular and orthopedic applications.
- James Schultz, executive vice president, ECA Medical Instruments in Thousand Oaks, Calif. ECA designs and manufactures single-procedure, torque-limiting and fixed-driver surgical instruments and turnkey kits for the medical implant, trauma, spine and reconstructive surgical sectors. The company has R&D, injection molding and manufacturing facilities, including ISO 7 clean-room operations.
1. Orthopedic Design & Technology: How has R&D in the orthopedic industry changed over the last few years from your perspective? What’s driving the change?
Emily Ho: When I first started in orthopedics about 10 years ago, many implants were intended for treating back pain. Now we’re seeing a lot of tissue-engineered biological scaffolds and injectable products. Currently, there are two key forces in orthopedics—first, anything that’s driving minimally invasive procedures to repair bone defects. This could include injectable bone materials. Secondly, companies are launching products to repair soft tissue such as cartilage and tendons. The cost of hospital stays are an influencing factor in promoting minimally invasive surgery, along with addressing how quickly a patient can recover from a procedure without incurring additional pain. In orthopedics, a lot is driven by the pain level or pain score, and how fast a patient can return to work. It’s not as much about the treatment as it is about how quickly the device can restore or improve a
patient’s quality of life.
Jim Schultz: Today’s R&D environment is experiencing greater scrutiny by management to bring products to market that have measurable value and sustained benefits. The trend in the dominant U.S. market is moving toward a “socialized medicine” model with reimbursement limits and spiraling hospital costs making OEMs rethink what the right products and instrument sets are going forward. Business as usual and in many cases using the same suppliers will not sustain margins nor grow market share and emerging market growth isn’t fast enough to offset margin erosion in established markets. The drive to save costs and the need to accelerate new products to market while working in a highly regulated environment is straining every step of the product development process and requiring some new thinking.
For example, if you want to convert costly reusable surgical instruments to single use you want to collaborate with a firm that understands injection modeling, plastics and merging of stainless steel materials and has a track record fielding medical disposables and not just impose the requirement on a contract manufacturer or an existing reusable instrument supplier. That approach will result in a lot of effort that will yield modest incremental cost savings and a “Band-Aid” answer. The best solution is one that embraces a different mindset and methodology that can be game-changing and put up barriers to competition.
Mike Carroll: Since costs are lower, R&D activities are becoming more aimed at cost-effective solutions, not just for implants, but for surgical procedures. New technology has become more difficult to introduce because of cost constraints and the burden of proof required by healthcare institutions, physicians and patients. As a result, the introduction of new technology related to implants will slow.
Peter Bayer: We’re seeing a lot more activity internationally. The growth of a middle class in China and India especially is driving much of this change, generating increased demand for orthopedic products in these markets. We’ve also seen a trend toward single-use devices. The cost of providing multiple, large reusable instrument sets to the field is becoming increasingly difficult for OEMs to bear. Hospitals are also starting to appreciate the simplicity of products that are delivered with everything required for the procedure in a single peel-pack. They do not have to manage, store and reprocess large instrument sets, and single-use products lower cross-contamination risks.
Ken Gall: Surgeons are demanding surgical solutions that not only serve a mechanical or structural function but also promote biologic healing and/or integration. This is driving companies to develop implants that are bio-active or release biologics. MedShape has begun to meet this demand through its recent development of a new biomaterial platform, a surface-porous PEEK (polyetheretherketone) called Scoria. Scoria was developed out of Georgia Tech (the George Institute of Technology in Atlanta) by a group of scientists and engineers. MedShape recognized the impact a porous PEEK material could have in the orthopedic industry and is licensing the technology.
2. ODT: What kinds of R&D challenges (or opportunities) are medical device makers facing and how do you respond? If you’re an OEM, are all of your R&D efforts internal?
Schultz: Driving out costs is crucial and that must be achieved on more than an incremental basis. Product life-cycle costs are being inspected like never before and cost centers are being eliminated. Some ortho/spine OEMs have instituted CEO initiatives requiring division leaders and corporate supply chain leaders to look across the enterprise and implement change that will make the company leaner and more efficient as fast as possible.
Simplifying the number of SKUs (stock-keeping units), for example, and using common tools across multiple platforms and moving to disposable instrumentation is the way of the future. We are collaborating with ortho/spine OEMs to help make them more competitive by driving out costs that can save them over $400 per procedure or $1 billion per year while concurrently bringing them value that can be translated to their customers, i.e. the hospital and ASCs (ambulatory surgery centers).
Sustained benefits like guaranteed sterile pack instruments and kits ready for use, always-accurate torque for implant fixation and reduced inventory management and sterile processing costs.
Carroll: For newer or start-up companies, the challenge is finding good talent and retaining that talent. In addition, good market research and strategic planning is critical to focus R&D efforts. We have a mix of both internal and external R&D, with the most being internal.
Ho: In the orthopedics world, the challenge is two-fold. There is the issue of acceptance of new materials in a barely penetrated market due to concern about adverse side effects; clinical requirements involve much more time. The other challenge is design evolution and how it will dramatically change existing procedures. For example, a procedure that involves repairing a screw for a hip joint is completely different and therefore requires a surgeon to learn additional skills, along with how to use the new technology. The biggest opportunity here involves incremental change. In addition, since surgeons are less willing to accept new materials, we have even more to prove in demonstrating that a new material can provide benefits over existing materials in use—for example, that it reduces time, money and resources. From our perspective, we demonstrate the benefits of the material from a manufacturing and compliance standpoint, along with how much easier it will be for surgeons to use our material during a surgical procedure. It’s important for a material to shorten surgery time while ensuring that it reduces inflammation or rejection risk post-surgery. These two points provide a financial benefit as well, as they reduce the occurrence of adverse events and secondary surgery.
Bayer: There have been two major challenges facing the orthopedics industry. The first is a continued push to reduce cost. Cost control is a key driver on almost all our projects. The second is the increasing complexity of the regulatory environment. We help our clients with cost issues by addressing them at the very start of the project. We’ll ask them to define cost and volume targets based on their business requirements. What does the manufacturing cost have to be for the business and the product to be successful? Understanding this critical requirement early on allows us to design the product to the required cost, using appropriate manufacturing processes.
We offer regulatory affairs consulting services to our clients to help them navigate the regulatory requirements for their products. Just as it is important to understand cost requirements as early as possible, it is equally important to develop a regulatory strategy at the beginning of a project. Our team will help a client develop a regulatory plan for the product based on the countries in which they intend to market the product. They will also help identify appropriate predicates and develop test plans tailored to the device classification and markets.
Gall: We have our own team of R&D engineers and scientists that work together to conceive, design, and manufacture our products. Our biggest challenge is being able to pursue all of the ideas we have taken up to proof of concept. Projects are prioritized by a combination of things including the importance of the clinical need being met, market opportunity, and ease of manufacturability and commercialization.
3. ODT: How do clinical and technical considerations converge in the research and development process, and how are they reconciled?
Carroll: Clinical considerations are always the basis for technical solutions in medical device research and development. The clinical and technical considerations crystallize, or are reconciled, into concepts for new products after the clinical need is communicated to the R&D engineers and scientists. After this, design inputs are finalized and the new product is developed. Manufacturing feasibility from a technical and cost perspective plays a large role in the complexity and duration of the R&D process as well.
Ho: Customers don’t always know what they want. In most cases, they give us a wish-list of clinical considerations. From an R&D point of view, we need to translate this into a technical requirement. For example, they might say they want their implant to be as strong as possible. However, you don’t want an implant to be as strong as possible, because the body cannot handle too strong of a product. The part of the body that has to work with this component or implant will undergo excess stress, which can lead to failure.
We also help customers understand the technical details of our products. If we’re working with a resorbable material, a customer might not understand that when you implant a resorbable to repair damage, you’re asking the patient’s body to heal naturally. We have to educate them about how our material is beneficial to the healing process—how it reduces inflammation and scar tissue, for example. From an R&D perspective, we make the connection between what the customers really want, what we can do, and how our quality system comes into play.
We need to ensure we have a standard process to make the product, so we help our customers understand any potential limitations and how we will ultimately deliver a consistent product with their desired properties.
Bayer: We view our projects as opportunities to bring our technical expertise together with the clinical expertise of consulting surgeons to provide optimal, clinically relevant solutions. There is no substitute for getting and incorporating user feedback throughout the development process. We also recognize the importance of getting feedback from multiple users. Certainly there are times when feedback from users conflicts with that from other users and with technical requirements. We find it helpful to work with users in a group setting so that the fundamental basis of a conflict is completely understood. Once conflicting requirements are understood we can work to find a suitable balance between the conflicting forces or design out the conflict to eliminate it.
Gall: There are always clinical needs that are difficult to satisfy and engineering solutions that serve no clinical need. But sometimes it is helpful to work in these extreme realms to make new discoveries. However, for the most part, we iterate on designs closely back and forth between engineers and surgeons to converge on a design that works and has clinical benefit.
Schultz: Any new product or instrument must pass the litmus test—it must provide clinical and economic value. If not, companies are asking why and how they can migrate to the position they need to be in to achieve company goals.
4. ODT: From which sectors of the orthopedic market are you seeing most of your business, and do those sectors come with unique requirements?
Schultz: We are seeing demand across the ortho and spine segments almost equally. Requirements are essentially the same. We must develop and field robust single-procedure solutions that can add measurable value to both the OEM and end-user. Driving out costs and providing competitive advantage in both established and emerging markets is critical. We must be agile, adaptive and execute.
Ho: In orthopedics, there’s always a desire for either addressing mechanical properties or promoting tissue regeneration. If I’m wearing my biomaterials hat, I can tell you about materials we offer that have limited mechanical properties but can encourage tissue regeneration. Such a material would be used for repairing bone fractures and could be in the form of a putty or plug. Our biomedical textiles processes allow us to improve the mechanical properties of biomaterials with less mass. Through knitting, braiding or weaving, we can provide mechanical properties that include stiffness, tensile strength and elasticity. Many biomedical textile devices we produce are made with shape-memory materials that can expand and change shape once implanted. This particular property promotes minimally invasive surgery, because a surgeon only needs to cut a small hole through which to implant the product, as it expands inside the body.
For example, using textile-forming processes, we can create a component that uses a smaller amount of shape-memory metal and combine it with a polymeric textile structure. Such components can be trained to change shape at body temperature, which allows the surgeon to squeeze it into a small area without making a large incision, as it reshapes into a larger structure inside the body.
Also, components with tailored properties that mimic natural soft tissue can be produced using biomedical textiles. Employing knitting, braiding and weaving processes, we can create a component that provides both flexibility and strength that is suitable for cartilage repair.
Bayer: We’re seeing a lot of activity in large joints. Typically, the focus is on developing quality, cost-effective products and not necessarily on developing products introducing a lot of innovation. There is a definite trend towards providing quality, generic, low-risk solutions. Large-joint product design does require expertise that differs from that needed, for example, in extremities or trauma. The design team in our Memphis facility has the large-joint expertise and experience that has led to many successful projects.
Carroll: Hips. Unique R&D requirements for this include a shift from traditional implant product-focused approach to that which is more focused on the surgical procedure. So the engineers we typically have a hard time finding are those who not only know the anatomy, but just as importantly have in-depth knowledge of instrument and mechanism design. Implant design experience is sometimes a less important job requirement than instrument design experience.
Gall: With the recent release of the Eclipse soft-tissue anchor and ExoShape ACL femoral fixation device, we are seeing outstanding growth in the foot/ankle and sports medicine sectors. Both markets require devices that simplify the procedure and allow for an anatomic repair. We believe we have addressed market demands with these new product offerings.
5. ODT: How are your R&D processes, practices and technologies updated or altered to respond to market trends, clinical needs and/or different customer requirements?
Schultz: We’re investing in people, key infrastructure and resources that position us to effectively react to the avalanche of pent up demand across the marketplace to eliminate cost centers, convert traditional instruments and surgical kits, where practical, to single use and modify or scrap business models that no longer scale. Serving as a collaborative partner with our OEM customers brings innovative solutions to them that can be translated into new customers in new markets and also sustained margins at home.
Ho: When seeking FDA (U.S. Food and Drug Administration) approval, companies must undergo either the 510(k) or PMA (premarket application) process. They need to have design controls. Since we’re not a device company, we’re technically not required to have design controls, but that doesn’t mean we don’t provide the documentation required. Our internal integrated product development process (IPDP) mimics the different phases in design control. We have two feasibility phases that drive design freeze, after which we conduct process optimization qualification, followed by process qualification. Our IPDP gives us a high confidence that we’re reducing risk and ensuring consistency.
The Lean process also helps us reduce ultimate product cost for our customers. When the customer needs to submit their product for regulatory approval, we can provide them with the validated statistical data required, while also helping them build the product’s design history file and ensuring traceability.
Bayer: We completely revamped our product development process last year to leverage everything we’ve learned since we opened our doors nine years ago. A key feature of the updated process is the integration of design transfer (DT) activities throughout the entire project. Rather than leave DT to the very end, we’ve pushed DT activities as far upstream in the process as possible. As an example, we start selecting materials and manufacturing processes in the concept phase, so that our concepts move quickly towards manufacturability and cost effectiveness. The integration of DT activities throughout the project provides the client with a smooth, quick and cost effective transfer of the product into manufacturing. Our approach minimizes the costly delays and surprises that often occur when DT is left to the very end of the project. We’ve also added a custom-built test cell for evaluating cutting instruments and screws. This new test cell allows us to provide quantitative information to the client on cutting instrument performance in terms of speed and efficiency. The cell also allows us to perform ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws) screw testing, either on an investigational basis or for formal verification testing.
Gall: We have not altered our core processes and practices very much in response to clinical needs. However, the constant push for lower-cost devices has required us to consider out-of-the-box, cost-effective manufacturing that still provides high-quality products. We often employ injection molding to manufacture our implants and instrument parts as a means to help alleviate costs.
Carroll: All processes are updated from time to time to keep pace with the changing regulatory environment. Since some trends require different levels of scrutiny by regulatory bodies, specifically those related to an increase in clinical assessment, requirements for new products and product development must focus on a smaller number of projects. Many novel technologies require the industry to develop new assessment methodologies and propose these to regulatory bodies much sooner in the R&D process than done in the past.