Ranica Arrowsmith, Associate Editor05.06.15
“How does one design something that is complex?” asked J.W. Senders in a 2006 article that appeared in the journal Quality & Safety—previously Quality & Safety in Health Care—titled “On the complexity of medical devices and systems.” A simple question for a complex (forgive me) subject. Just a decade ago, when Senders wrote this article, medical device complexity meant something quite different than it does today in 2015. Outside of the actual manufacturing “how,” though, the larger philosophical question of what exactly complexity means remains more or less the same.
According to Senders, “complexity has been held responsible for emergent (unexpected, surprising) behavior of medical devices and systems.” Complexity is not what a medical device intrinsically is, but rather is a perceived characteristic not necessarily related to the number of components or their interconnectivity. He gives the example of his right arm, which is biologically, physically and chemically complex, but rather simple in function and very easy for him to use. To Senders’ point about simple devices possibly being complex in application and function, a 2001 Ergonomics in Design article titled “Analysis of a ‘Simple’ Medical Device” demonstrated that human factors, especially with the rise of home-use devices, can complicate the use of any medical device. The authors used a blood glucose meter as an example. “It’s as easy as 1, 2, 3,” a videotape accompanying a commonly used blood glucose meter pronounced. But the authors said, “definitely not.” While the instructions touted only three simple steps, in reality, there were 52 substeps involved in using this meter correctly. Another commonly used meter tested by the authors broke down into a whopping 61 substeps.
It is easy to see how in 62 steps, a user can get lost along the way, which leads to those unexpected problems to which Senders referred. In fact in 2010, the U.S. Food and Drug Administration (FDA) addressed this very problem, namely, that of expecting patients to use complicated devices at home. The agency launched the Medical Device Home Use Initiative to address the growing migration of hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices and ventilators to the home.
“Using complex medical devices at home carries unique challenges,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning.”
“We are in a period of high disruption, particularly as user focused design drives meaningful value to the healthcare ecosystem alongside clinical efficacy,” said Aidan Petrie, chief innovation officer at Providence, R.I.-based Ximedica LLC, which designs, developments and manufactures FDA-regulated medical products. “During the mid-century to early 1980s, innovation was all about tool development. In the 1980-90s, technology began to drive the innovation of tools—then comes 2000 and the advent of the iPhone which sees technology and innovation driven by the user experience and need. And that’s where we are today, which serendipitously aligns with the FDA’s user focus.”
The iPhone is the perfect example of the uneasy shift of medical devices into the hands of patient users. Blood glucose meters, etc., are at least a lot easier to regulate than software apps available on mobile devices. The FDA initiated a preliminary labeling repository pilot in 2011, which provided manufacturers of devices labeled for home use with the opportunity to voluntarily and electronically submit their labeling to the agency through the FDA Gateway using an existing system for drug labeling. In April this year, the CDRH announced the availability of an electronic submission for the Home Use Device Labeling Pilot Program. These programs are designed to help evaluate whether the labeling on home use devices provide adequate instructions and information to users.
So, medical device makers strive for the right arm—that is, almost unimaginable complexity in a device in order to make that device more useful, user-friendly, intuitive and effective than ever before. This is the call medical device design engineers face, and it is unrelenting. It is not a new demand, but developments in surgical technique, disease discoveries and manufacturing technology advancements pave the way for more complex medical devices that treat more complex ailments, or that have more specific or generalized applications.
For instance, The Tech Group, a subsidiary of Lionville, Pa.-based West Pharmaceutical Services Inc., which is a contract manufacturer of medical devices, has met the burgeoning demand for medical devices compatible with wireless data systems with increased complexity.
“As a contract manufacturer of medical devices, and serving the needs of OEMs, we have noticed a shift in the need for integrated electronic devices capable of providing user data,” Mark Mcelfresh, vice president of operations and supply chain for The Tech Group, told Medical Product Outsourcing. “The trend toward interconnection of medical devices and combination products via the integration of wireless and wearable technology will continue to grow. We continue to see this technology make its way into a variety of applications in both clinical and managed health care settings.
“Given this trend, the devices themselves are more complex, leading to advanced manufacturing and assembly solutions and regulatory compliance challenges related to electronics. Additionally, the device design complexity and innovation is being completed in shorter development cycles. Advancements in metrology and 3-D model technologies have aided in reducing the duration of the product development life cycle. The implication for device developers is that user needs and technical requirements are going to become more complex, which underscores the importance of establishing robust design inputs that are based on a deep understanding of all these factors and leveraging them into differentiated devices.”
While its offerings become more complex, the company is providing devices that provide a way for clinicians and patients to interact more easily—wireless data transfer—and have also managed to shorten the actual development cycle in the manufacture of the device. Complexity and simplicity go hand in hand.
Complexity and Miniaturization
“We believe a culture of innovation is best developed through cross-functional collaboration that addresses design programs from the perspective of all the factors that can contribute to success—including user experience/human factors, technical innovation, and scaling into a commercial product,” Mcelfresh continued. “We encourage and facilitate this collaboration throughout our organization. Technology has always been at the forefront of any process at The Tech Group. By providing the right tools to the right people, training them at these tools, and applying the knowledge at the right time during the design process, we are able to cultivate a very open and adaptive environment for our design engineers.
“By using the latest technologies we can explore new designs beyond the limits of conventional manufacturing processes and materials. We are implementing a program to use 3-D printing to create an injection mold, which enables us to produce prototypes with the same design as the production part with a few days of lead time. This compares with the weeks it takes to make molds in metal. Such investments in new technology excites the engineers, allowing them to fully utilize their skill set.”
Molding, which is a historically expensive manufacturing process that requires relatively large-volume production to bring in an adequate return on investment, is changing with the use of 3-D printing. Instead of ordering molds that are expensive to make and expensive to replace (if, say, a device component needs to be tweaked down the line and the mold has already been made), 3-D printing a mold quickly and easily is now possible with the rise in availability of affordable additive manufacturing machines.
Additive manufacturing, which has been in use since the 1980s, is now more than ever capable of creating the most complex object geometries. A favorite layman’s explanation of what this means for device design is the ability of 3-D printing to create a cube with a hollow center. Simple enough, but a seamless cube with a hollow sphere in its center cannot be created with any other manufacturing method. Hence, this manufacturing method, which has been making advancements in leaps and bounds in recent years as patents on related technologies expire and open up for wider use, is creating roadways to complexity in medical device design.
Another major facet of complexity in medical device design is size. Miniaturization has become foremost in certain medical device spaces, such as surgical instruments and implantable devices. Miniaturization ultimately can allow procedures to become less invasive, give surgeons more flexibility, and quicken healing times for patients. Over the past few years, Dublin, Ireland-based medical device maker Medtronic plc has been racking in international approvals for its tiny pacemaker called the Micra TPS (transcatheter pacing system). Marketed as “the world’s smallest, minimally invasive cardiac pacemaker—one-tenth the size of conventional pacemakers,” the latest iteration of the device really is just the size of a large vitamin pill. The pacemaker uses small tines—small nitinol wires which grip the heart, keeping the electrode in and holding the device in place—to attach to the heart rather than leads, thereby potentially eliminating a source of complications. It is in this placement methodology that the design of Micra is truly unique.
In discussing the design challenges of Micra last year, Medtronic’s vice president of bradycardia R&D and the Cardiac Rhythm and Heart Failure Division Mike Hess told EP Lab Digest, “The biggest [challenge] was probably on the current drain in terms of making the circuit extremely efficient, so we could use the small battery and still have devices last 10 years or more for most patients. Of course, the other feature was in recognizing this is not a lead-based device; we had to design a special fixation mechanism that would be appropriate for a capsule device as opposed to a traditional pacemaker.”
“Product miniaturization presents new challenges and opportunities for designers as well as manufacturers of medical devices and components,” added Todd Owens, vice president of engineering for Donatelle Plastics Inc., a New Brighton, Minn.-based medical device manufacturer. “Limitations of traditionally utilized manufacturing processes to create micro type products and features for medical applications are at the root of these challenges, including: current commercially available processing equipment and resolution of machine controls for micro products; advanced metrology (equipment and fixturing) at the micro level; product handling systems for micro components and assemblies; design-for-manufacturability knowledge within core micro technologies; and experienced personnel with knowledge in all of the above. The ability to consistently and reliably manufacture miniaturized products in a highly regulated industry is no different than it is for any other medical device application. This expectation is one of the elements that will continue to push the market to bridge the gaps that currently exist.”
Designing for a Complex World
Returning to simple designs to address complex needs, design engineers have to focus on complex issues presented by modern medical advancements. For instance, Medtronic’s Micra TPS not only is tiny, but it also is magnetic resonance imaging (MRI) safe. MRI works via very strong magnets, so patients with any kind of metallic implants such as orthopedic pins or pacemakers were denied this diagnostic technology for years. However, advancements in MRI materials, circuitry design and so on, have allowed the approval of several medical implants for magnetic imaging. Now, Micra is only one of many medical implants that have been declared MRI-safe by the FDA and other international regulatory bodies. Biotronik’s Eluna pacemaker system, Medtronic’s Activ deep brain stimulation devices, and Med-El USA’s Synchrony cochlear implants are just a few other examples.
Recently, Proven Process Medical Devices Inc. found itself facing this very problem. The Mansfield, Mass.-based design and manufacturing company for Class II and III medical devices was tasked with creating a next-generation drug infusion pump that is compatible with MRI for one of its clients. According to President Ken Fine, Proven Process lives by its name—the process of medical device development, from start to finish, is treated as a whole, integrated project, each stage as important as the next. Innovation in design is fostered by a team of engineers from every conceivable background—in house pharmacologists, outside opinion leaders and their customers’ medical advisory teams. For this particular MRI-safe infusion pump project and others, the company conducted research with high-end MRI machines at Massachusetts General Hospital.
“We recently developed a new version of an implantable drug infusion pump, which is safer for the patient,” Fine told MPO. “It treats chronic pain and other neurological disorders, and a lot of those patients—approximately 10 to 20 percent—routinely go under MRI. Most implanted devices and MRI don’t get along well with each other, so the challenge was to make an implantable device safer for people undergoing this type of scan. We got together and brainstormed—because we’re in hospital and clinic suites with physicians and patients, we understand what’s required for MRI. We knew what the real challenges were. We got a team with a wide variety of backgrounds and brainstormed on a number of technical solutions to the problem. The fundamental problems were to make sure the device survived MRI, that it doesn’t inappropriately release the drug into the patient, and certain other safety issues. We developed all kinds of ideas; we developed solutions and selection matrices to weigh those ideas objectively, and we let those run for a little while. We developed several different ideas all the way to prototype and collected data before we converged on which solution we thought would be the best—and earlier this year, our customer got premarket approval [from the FDA] so it worked out well.”
Keeping in mind manufacturing processes, brilliant design is useless without the ability to actually realize the idea. Three-dimensional printing has allowed for more complex geometries in both actual components and injection molds; micromachining and microtooling have allowed for the advancement of miniaturized design. A core function of contract manufacturing organizations is to educate their clients about design for manufacturability.
“Our culture here is very focused on process and design controls in order to make products that have the quality attributes that makes them successful in the market place,” explained Fine. “Many of our customers may come from other industries such as industrial design, and they need to learn the methods and tools to develop a robust, highly usable medical product that can be approved the first time through the FDA. Part of that is making sure we’re focused on the end user and not getting caught up in the technology of the product. Because we deal with the whole life cycle of a product, we can focus on the product as a whole solution instead of a disjointed product as if we only did part of it. Early on in concept development and product definition and all the way through the whole process, we can focus on design for manufacturability issues, design for service issues, design for testability issues early on because we provide all these services.”
“Our company has a strong focus on design for manufacturability, cost and performance,” added Barry Braunstein, vice president, business development-east for Acorn Product Development, a Newark, Calif.-based company that provides comprehensive product engineering services. “From the early concept development phase we are looking at how the concepts being developed measure against those (and other important customer) criteria, vs. waiting until the end of the design phase. This approach has allowed us to keep control over potential spiraling costs and missed performance objectives, and gives us a very high success rate in terms of meeting agreed-to customer requirements. We also perform a good deal of simulation and analysis prior to building prototypes—it’s very easy and fast to iterate designs in software vs. physical prototypes. We’ve found this approach reduces the number of prototype spins, and ultimately yields a product that is more manufacturable.
“We recently completed an exoskeleton project, where strength, weight, comfort and costs are all factors that needed to be managed in order to design a successful system. The system also needed to be compact enough to be worn, and rugged enough to withstand rigorous testing. After some initial brainstorming and concept down-selection, we started identifying and working with suppliers to determine the manufacturability and cost of the most promising concepts. We were able to successfully complete and fabricate the design, and it passed the rigorous testing with flying colors.”
Finally, complexity does not end with pure device design. The world in which medical devices operate is an interconnected web of safety requirements and demands, regulatory complexities that differ market to market, patient demands, clinician demands, etc. ad infinitum.
“One of the latest big challenges/opportunities on the device side is how complex and diverse solutions have become—this includes patient engagement, record handling, technology complexity, stakeholder interaction, comparative outcomes and reimbursement,” Sean McLeod, president of Stratos Product Development LLC, a Seattle, Wash.-based technological product design and development firm, told MPO. “Regulatory uncertainty has increased along with these complexities and there is a definitive shift underway in healthcare delivery—such as with accountable care organizations. With this complexity comes a greater range of expertise, partnering and contributing individuals when developing a product or solution which necessitates a competency in evaluating, nurturing,and managing these relationships.”
According to Senders, “complexity has been held responsible for emergent (unexpected, surprising) behavior of medical devices and systems.” Complexity is not what a medical device intrinsically is, but rather is a perceived characteristic not necessarily related to the number of components or their interconnectivity. He gives the example of his right arm, which is biologically, physically and chemically complex, but rather simple in function and very easy for him to use. To Senders’ point about simple devices possibly being complex in application and function, a 2001 Ergonomics in Design article titled “Analysis of a ‘Simple’ Medical Device” demonstrated that human factors, especially with the rise of home-use devices, can complicate the use of any medical device. The authors used a blood glucose meter as an example. “It’s as easy as 1, 2, 3,” a videotape accompanying a commonly used blood glucose meter pronounced. But the authors said, “definitely not.” While the instructions touted only three simple steps, in reality, there were 52 substeps involved in using this meter correctly. Another commonly used meter tested by the authors broke down into a whopping 61 substeps.
It is easy to see how in 62 steps, a user can get lost along the way, which leads to those unexpected problems to which Senders referred. In fact in 2010, the U.S. Food and Drug Administration (FDA) addressed this very problem, namely, that of expecting patients to use complicated devices at home. The agency launched the Medical Device Home Use Initiative to address the growing migration of hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices and ventilators to the home.
“Using complex medical devices at home carries unique challenges,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product’s functioning.”
“We are in a period of high disruption, particularly as user focused design drives meaningful value to the healthcare ecosystem alongside clinical efficacy,” said Aidan Petrie, chief innovation officer at Providence, R.I.-based Ximedica LLC, which designs, developments and manufactures FDA-regulated medical products. “During the mid-century to early 1980s, innovation was all about tool development. In the 1980-90s, technology began to drive the innovation of tools—then comes 2000 and the advent of the iPhone which sees technology and innovation driven by the user experience and need. And that’s where we are today, which serendipitously aligns with the FDA’s user focus.”
The iPhone is the perfect example of the uneasy shift of medical devices into the hands of patient users. Blood glucose meters, etc., are at least a lot easier to regulate than software apps available on mobile devices. The FDA initiated a preliminary labeling repository pilot in 2011, which provided manufacturers of devices labeled for home use with the opportunity to voluntarily and electronically submit their labeling to the agency through the FDA Gateway using an existing system for drug labeling. In April this year, the CDRH announced the availability of an electronic submission for the Home Use Device Labeling Pilot Program. These programs are designed to help evaluate whether the labeling on home use devices provide adequate instructions and information to users.
So, medical device makers strive for the right arm—that is, almost unimaginable complexity in a device in order to make that device more useful, user-friendly, intuitive and effective than ever before. This is the call medical device design engineers face, and it is unrelenting. It is not a new demand, but developments in surgical technique, disease discoveries and manufacturing technology advancements pave the way for more complex medical devices that treat more complex ailments, or that have more specific or generalized applications.
For instance, The Tech Group, a subsidiary of Lionville, Pa.-based West Pharmaceutical Services Inc., which is a contract manufacturer of medical devices, has met the burgeoning demand for medical devices compatible with wireless data systems with increased complexity.
“As a contract manufacturer of medical devices, and serving the needs of OEMs, we have noticed a shift in the need for integrated electronic devices capable of providing user data,” Mark Mcelfresh, vice president of operations and supply chain for The Tech Group, told Medical Product Outsourcing. “The trend toward interconnection of medical devices and combination products via the integration of wireless and wearable technology will continue to grow. We continue to see this technology make its way into a variety of applications in both clinical and managed health care settings.
“Given this trend, the devices themselves are more complex, leading to advanced manufacturing and assembly solutions and regulatory compliance challenges related to electronics. Additionally, the device design complexity and innovation is being completed in shorter development cycles. Advancements in metrology and 3-D model technologies have aided in reducing the duration of the product development life cycle. The implication for device developers is that user needs and technical requirements are going to become more complex, which underscores the importance of establishing robust design inputs that are based on a deep understanding of all these factors and leveraging them into differentiated devices.”
While its offerings become more complex, the company is providing devices that provide a way for clinicians and patients to interact more easily—wireless data transfer—and have also managed to shorten the actual development cycle in the manufacture of the device. Complexity and simplicity go hand in hand.
Complexity and Miniaturization
“We believe a culture of innovation is best developed through cross-functional collaboration that addresses design programs from the perspective of all the factors that can contribute to success—including user experience/human factors, technical innovation, and scaling into a commercial product,” Mcelfresh continued. “We encourage and facilitate this collaboration throughout our organization. Technology has always been at the forefront of any process at The Tech Group. By providing the right tools to the right people, training them at these tools, and applying the knowledge at the right time during the design process, we are able to cultivate a very open and adaptive environment for our design engineers.
“By using the latest technologies we can explore new designs beyond the limits of conventional manufacturing processes and materials. We are implementing a program to use 3-D printing to create an injection mold, which enables us to produce prototypes with the same design as the production part with a few days of lead time. This compares with the weeks it takes to make molds in metal. Such investments in new technology excites the engineers, allowing them to fully utilize their skill set.”
Molding, which is a historically expensive manufacturing process that requires relatively large-volume production to bring in an adequate return on investment, is changing with the use of 3-D printing. Instead of ordering molds that are expensive to make and expensive to replace (if, say, a device component needs to be tweaked down the line and the mold has already been made), 3-D printing a mold quickly and easily is now possible with the rise in availability of affordable additive manufacturing machines.
Additive manufacturing, which has been in use since the 1980s, is now more than ever capable of creating the most complex object geometries. A favorite layman’s explanation of what this means for device design is the ability of 3-D printing to create a cube with a hollow center. Simple enough, but a seamless cube with a hollow sphere in its center cannot be created with any other manufacturing method. Hence, this manufacturing method, which has been making advancements in leaps and bounds in recent years as patents on related technologies expire and open up for wider use, is creating roadways to complexity in medical device design.
Another major facet of complexity in medical device design is size. Miniaturization has become foremost in certain medical device spaces, such as surgical instruments and implantable devices. Miniaturization ultimately can allow procedures to become less invasive, give surgeons more flexibility, and quicken healing times for patients. Over the past few years, Dublin, Ireland-based medical device maker Medtronic plc has been racking in international approvals for its tiny pacemaker called the Micra TPS (transcatheter pacing system). Marketed as “the world’s smallest, minimally invasive cardiac pacemaker—one-tenth the size of conventional pacemakers,” the latest iteration of the device really is just the size of a large vitamin pill. The pacemaker uses small tines—small nitinol wires which grip the heart, keeping the electrode in and holding the device in place—to attach to the heart rather than leads, thereby potentially eliminating a source of complications. It is in this placement methodology that the design of Micra is truly unique.
In discussing the design challenges of Micra last year, Medtronic’s vice president of bradycardia R&D and the Cardiac Rhythm and Heart Failure Division Mike Hess told EP Lab Digest, “The biggest [challenge] was probably on the current drain in terms of making the circuit extremely efficient, so we could use the small battery and still have devices last 10 years or more for most patients. Of course, the other feature was in recognizing this is not a lead-based device; we had to design a special fixation mechanism that would be appropriate for a capsule device as opposed to a traditional pacemaker.”
“Product miniaturization presents new challenges and opportunities for designers as well as manufacturers of medical devices and components,” added Todd Owens, vice president of engineering for Donatelle Plastics Inc., a New Brighton, Minn.-based medical device manufacturer. “Limitations of traditionally utilized manufacturing processes to create micro type products and features for medical applications are at the root of these challenges, including: current commercially available processing equipment and resolution of machine controls for micro products; advanced metrology (equipment and fixturing) at the micro level; product handling systems for micro components and assemblies; design-for-manufacturability knowledge within core micro technologies; and experienced personnel with knowledge in all of the above. The ability to consistently and reliably manufacture miniaturized products in a highly regulated industry is no different than it is for any other medical device application. This expectation is one of the elements that will continue to push the market to bridge the gaps that currently exist.”
Designing for a Complex World
Returning to simple designs to address complex needs, design engineers have to focus on complex issues presented by modern medical advancements. For instance, Medtronic’s Micra TPS not only is tiny, but it also is magnetic resonance imaging (MRI) safe. MRI works via very strong magnets, so patients with any kind of metallic implants such as orthopedic pins or pacemakers were denied this diagnostic technology for years. However, advancements in MRI materials, circuitry design and so on, have allowed the approval of several medical implants for magnetic imaging. Now, Micra is only one of many medical implants that have been declared MRI-safe by the FDA and other international regulatory bodies. Biotronik’s Eluna pacemaker system, Medtronic’s Activ deep brain stimulation devices, and Med-El USA’s Synchrony cochlear implants are just a few other examples.
Recently, Proven Process Medical Devices Inc. found itself facing this very problem. The Mansfield, Mass.-based design and manufacturing company for Class II and III medical devices was tasked with creating a next-generation drug infusion pump that is compatible with MRI for one of its clients. According to President Ken Fine, Proven Process lives by its name—the process of medical device development, from start to finish, is treated as a whole, integrated project, each stage as important as the next. Innovation in design is fostered by a team of engineers from every conceivable background—in house pharmacologists, outside opinion leaders and their customers’ medical advisory teams. For this particular MRI-safe infusion pump project and others, the company conducted research with high-end MRI machines at Massachusetts General Hospital.
“We recently developed a new version of an implantable drug infusion pump, which is safer for the patient,” Fine told MPO. “It treats chronic pain and other neurological disorders, and a lot of those patients—approximately 10 to 20 percent—routinely go under MRI. Most implanted devices and MRI don’t get along well with each other, so the challenge was to make an implantable device safer for people undergoing this type of scan. We got together and brainstormed—because we’re in hospital and clinic suites with physicians and patients, we understand what’s required for MRI. We knew what the real challenges were. We got a team with a wide variety of backgrounds and brainstormed on a number of technical solutions to the problem. The fundamental problems were to make sure the device survived MRI, that it doesn’t inappropriately release the drug into the patient, and certain other safety issues. We developed all kinds of ideas; we developed solutions and selection matrices to weigh those ideas objectively, and we let those run for a little while. We developed several different ideas all the way to prototype and collected data before we converged on which solution we thought would be the best—and earlier this year, our customer got premarket approval [from the FDA] so it worked out well.”
Keeping in mind manufacturing processes, brilliant design is useless without the ability to actually realize the idea. Three-dimensional printing has allowed for more complex geometries in both actual components and injection molds; micromachining and microtooling have allowed for the advancement of miniaturized design. A core function of contract manufacturing organizations is to educate their clients about design for manufacturability.
“Our culture here is very focused on process and design controls in order to make products that have the quality attributes that makes them successful in the market place,” explained Fine. “Many of our customers may come from other industries such as industrial design, and they need to learn the methods and tools to develop a robust, highly usable medical product that can be approved the first time through the FDA. Part of that is making sure we’re focused on the end user and not getting caught up in the technology of the product. Because we deal with the whole life cycle of a product, we can focus on the product as a whole solution instead of a disjointed product as if we only did part of it. Early on in concept development and product definition and all the way through the whole process, we can focus on design for manufacturability issues, design for service issues, design for testability issues early on because we provide all these services.”
“Our company has a strong focus on design for manufacturability, cost and performance,” added Barry Braunstein, vice president, business development-east for Acorn Product Development, a Newark, Calif.-based company that provides comprehensive product engineering services. “From the early concept development phase we are looking at how the concepts being developed measure against those (and other important customer) criteria, vs. waiting until the end of the design phase. This approach has allowed us to keep control over potential spiraling costs and missed performance objectives, and gives us a very high success rate in terms of meeting agreed-to customer requirements. We also perform a good deal of simulation and analysis prior to building prototypes—it’s very easy and fast to iterate designs in software vs. physical prototypes. We’ve found this approach reduces the number of prototype spins, and ultimately yields a product that is more manufacturable.
“We recently completed an exoskeleton project, where strength, weight, comfort and costs are all factors that needed to be managed in order to design a successful system. The system also needed to be compact enough to be worn, and rugged enough to withstand rigorous testing. After some initial brainstorming and concept down-selection, we started identifying and working with suppliers to determine the manufacturability and cost of the most promising concepts. We were able to successfully complete and fabricate the design, and it passed the rigorous testing with flying colors.”
Finally, complexity does not end with pure device design. The world in which medical devices operate is an interconnected web of safety requirements and demands, regulatory complexities that differ market to market, patient demands, clinician demands, etc. ad infinitum.
“One of the latest big challenges/opportunities on the device side is how complex and diverse solutions have become—this includes patient engagement, record handling, technology complexity, stakeholder interaction, comparative outcomes and reimbursement,” Sean McLeod, president of Stratos Product Development LLC, a Seattle, Wash.-based technological product design and development firm, told MPO. “Regulatory uncertainty has increased along with these complexities and there is a definitive shift underway in healthcare delivery—such as with accountable care organizations. With this complexity comes a greater range of expertise, partnering and contributing individuals when developing a product or solution which necessitates a competency in evaluating, nurturing,and managing these relationships.”