Ranica Arrowsmith, Associate Editor07.31.13
How do you construct a sign that not only will last for 10,000 years, but also will effectively communicate its message to 10,000 years worth of populations, be they human or alien? This is a real question that has concerned the U.S. Department of Energy (DOE) since the 1980s, when the world started to face the need for a place to dispose of nuclear waste. The United States’ radioactive waste produced by the research and production of nuclear weapons is disposed of in Eddy County, N.M., where the Waste Isolation Pilot Plant is located. Following the interment of waste in the facility, the storage caverns in the 600-meter deep natural salt caverns will be collapsed and sealed with 13 layers of concrete and soil. Salt will then seep into and fill the various fissures and cracks surrounding the casks of waste. After approximately 75 years, the waste will be completely isolated from the environment.
But that will not be enough to guarantee the safety of future visitors. The internationally used symbol for radioactivity is the trefoil symbol—a dot surrounded by three blades—indicating not to proceed any further for one’s own safety. The question is whether that symbol, or any other symbol in any color we can conceive of, will be certain to convey its message unequivocally to any being that comes across it. In May 2006, Salt Lake City, Utah-based writer and programmer Alan Bellows articulated the issue the DOE faced and still faces today:
“If you look at it just right, the universal radiation warning symbol looks a bit like an angel,” Bellows wrote for the popular science website damninteresting.com. “The circle in the middle could indicate the head, the lower part might be the body, and the upper two arms of the trefoil could represent the wings. Looking at it another way, one might see it as a wheel, a triangular boomerang, a circular saw blade, or any number of relatively benign objects. Whatever a person’s first impression of it may be, someone unfamiliar with the symbol probably wouldn’t guess that it means ‘Danger!’”
In a world that is now irreversibly globalized and, figuratively speaking, smaller than ever, design professionals face the “lost in translation” issue every single day. How do you design a medical device whose function will easily be understood by Americans, Danes, and Chinese? How do you word an instruction so that it will be translatable from Italian to Korean with its key concepts preserved? If a button is tinted green, will that read as “safe” in non-Western cultures? These seemingly small considerations plague medical device designers who are building technologies that must be used correctly—patients’ lives depend on it.
Dan O’Sullivan, director of design for FARM Design Inc., a Hollis, N.H.-based product development company, recalled a glucometer his company designed that was going to be used in Japan. The device had icons on it to indicate how to use it before and after meal times. FARM chose a whole apple to indicate use before a meal, and an apple with bites taken out of it to indicate use post-meal.
“When we showed the apple core with the bites around it in Japan, they didn’t know what that was because they don’t eat an apple like that,” O’Sullivan told Medical Product Outsourcing. “They don’t bite into an apple and leave a big tooth mark. They cut it up and dice it up into small pieces. Within the context of that medical device in that country, that icon didn’t make any sense to them. We would either have to make one specifically for Japan, or try to come up with something different that wouldn’t cause that same problem.”
There is no comprehensive, universal set of symbols that medtech designers can refer to when considering placing instructional iconography on a device’s hardware. The Society for Environmental Graphic Design and Hablamos Juntos, a non-profit organization aimed at improving healthcare communication for Latinos, joined to create a system of symbols that indicate items such as “ambulance,” “emergency,” and various hospital departments. This is one of the only sets of standard healthcare-related iconography, and it is not very helpful to medical device designers. In fact there is no useful set of icons, whether universal or even region-specific, that can be used effectively by medical device designers, O’Sullivan noted.
“What we try to do is look at the context of the system that we’re designing,” said O’Sullivan. “What are the other systems that healthcare professionals or patients might use so that we understand what they’re familiar with? Then we’ll try to draw conclusions on whether there’s familiarity between different countries or areas and design for that. In one example, we were working on a diagnostic lab device, and we were trying to create this magical collection of universal iconography. We determined that there were a certain amount of things that the systems around them do: They all check for patient identification; they have a task list; they test workflow; they run a test; they stop a test; there’s an error warning. Those are what we call system independent iconography. And then there’s system dependent iconography. In this particular example, there was a very unique reagent bottle that we designed for this system. The average person who looked at it would have no idea what it was, so it was not very universal, but it was very specific to the context of this product if you were a trained user. So we developed two different sets of icons: one that was more universal, perhaps understandable by the average person outside of the context of the device; and a whole set that was more specific to the physical form, colors and relationships that were associated with that actual device.”
As Costs Are Forced Down, Complex Tech Trends Up
One natural trend that has emerged from globalization and the boom in personal technology is the rise in telehealth. This, in turn, is connected to the trend toward home use devices—which today, can mean an app on an iPhone—which keep patients out of the hospital and, consequently, keep health care costs down. Also on the rise are wirelessly accessible devices, which enables physicians to conduct check ups remotely.
“Because cell phones are ubiquitous, and the fact that it’s so easy to create apps and add small accessories to a given instrument, you all of a sudden now have a diagnostic device in your hands at a very low cost,” said O’Sullivan. “It would allow a physician to have more frequent check-ins or even patient monitoring at a very low cost, without requiring as many visits to the hospital or the clinic.”
In the midst of the trend towards wireless technology and telehealth, the U.S. Food and Drug Administration (FDA) has been dragging its feet on establishing regulations on cybersecurity. As the issue creeps to the forefront, the agency has issued various guidances to help device manufacturers implement protections for their devices.
According to the agency, the general principles device manufacturers should keep in mind are confidentiality, integrity and availability. Confidentiality means that data, information, or system structures are accessible only to authorized persons and entities and are processed at authorized times and in the authorized manner, thereby helping ensure data and system security. Confidentiality provides the assurance that no unauthorized user has access to the data, information, or system structures. Integrity means that data and information are accurate and complete and have not been improperly modified. Availability means that data, information, and information systems are accessible and usable on demand.
MPR Associates Inc., located in the FDA’s backyard of Alexandra, Va., has put together comprehensive approaches to cybersecurity for devices they design that include software or other vulnerable wireless technologies. General Manager of product development Eric Claude detailed three of the top ways in which MPR protects its wirelessly capable devices.
The first is managing the “directionality of communication.” The device is set up so that it only communicates data outwards, and is incapable of receiving data of any kind.
“In some applications there is actually a benefit for devices being able to receive data,” Claude said. “For example, loading updated firmware or software onto a device. That clearly opens you up to a bigger risk, so it’s important for device developers to recognize the risks associated with that kind of functionality.”
The second approach is “segregation.” Two entirely different processors exist in the device. One manages the outgoing and/or incoming communication, while the other manages the function of the device. Claude described it as “two separate computers running side by side doing different things”.
The third approach—and MPR has more under its belt, but these are the three main ones—is to implement a proprietary or high-security communication protocol.
“It’s like I’m speaking my own language to my computers and they don’t understand anybody else’s language.”
“The whole issue of security is obviously a big one, and we do seem to be on the forefront of who’s going to take the first leap; who’s going to blaze that trail, go up against the FDA and put a system in place that is secure enough,” O’Sullivan said. “A lot of the smaller companies are probably holding back a little bit, waiting to see who’s going to spend the most money to blaze that trail, and then there may be many who are quick to follow.”
While the FDA has not yet come up with clear guidelines on cybersecurity, it certainly will eventually. Claude stressed the importance of implementing compliance and risk mitigation strategies sooner rather than later in anticipation of regulation.
“Unless your device has no electronics whatsoever, you must have something in your risk analysis and product specifications about cybersecurity issues, because the FDA is going to look for it,” warned Claude. “The way we approach it is that our risk analysis drives the strategy. We look at how a device is going to be used or misused, what the risks are, and how you deal with them. So when FDA asks how are you dealing with cybersecurity, the first thing you do is you break out your risk analysis and you point them to that section and your show them what you’re doing.”
The hope that the increase in telehealth and other wireless technologies will keep costs down is a fervent one.
“Nowadays, the cost of going to the hospital for treatment or any services is relatively expensive,” said Joe Tam, senior manager of the R&D department for contract design and manufacturer Providence Enterprise LLC. “It will be time consuming and inconvenient for elderly people to visit the doctor. Also, a huge amount of money is required to build more hospitals to fulfill and accommodate the growing aging population.”
In fact, John Slate, Ph.D., senior systems engineer from Escondido, Calif.-based Fallbrook Engineering Inc., was faced with a startling realization at a recent conference sponsored by the National Institutes of Health. A venture capital investor speaking at the conference said that a full two thirds of both people with investment money looking for funding opportunities and the funding itself are gone from the medtech market—permanently.
“Most of the funding that is being reported is going into follow-on rounds as opposed to new startups. The medical space is not as much of a financial gold mine as it used to be,” Slate said. “The medical device tax has really hurt the industry; getting regulatory approval in a timely fashion has been difficult; the time from inception to market is longer than it used to be; and the bar that you have to get over to show that your product meets all the requirements has become more difficult.”
While many companies have noticed a significant trend towards software and telehealth technologies, Fallbrook Engineering has noticed an uptick in bioresorbables. In a way connected with the increasing capabilities engineers have as technology advances, expensive, highly complicated bioresorbable materials are rising in demand.
“Bioresorbables have been around for more than 20 years,” said Richard Meyst, president and principal consultant for Fallbrook Engineering. “The materials are very expensive, but interest in them is rising both from designers and medical device companies. This is partly due to media exposure, which has made people aware of them again, but also because they can solve a lot of difficult problems traditional materials cannot.”
Meyst went on to say that while they are very useful medical materials, bioresorbables are not easy to engineer and require very advanced technical expertise. Drug eluting stents, for instance, must emit a very specific dose of drug over a specific amount of time in regulated doses.
“Designing something to last only as long as you want it to is not easy,” Meyst said.
New Approaches to Design
In light of how quickly telehealth—also known by connected health, e-health, health IT, and various other monikers—is growing, contract design firms are noticing a shift in how design clients approach new devices.
One of the most basic medical devices that we still use today is the hypodermic needle and syringe. The device was invented in 1853. Dr. Alexander Wood is credited for the invention. He had been experimenting with a hollow needle to administer drugs, and he eventually felt confident enough in his approach to publish a short paper in the Edinburgh Medical and Surgical Journal called “A New Method of treating Neuralgia by the direct application of Opiates to the Painful Points.”
Before the advancement of technology started accelerating at breakneck speeds somewhere in the late 20th century, conceiving an idea and fashioning a rudimentary medical device was simple. Today, when an idea is born, it can come from various avenues. An entrepreneur might have an idea, but she may not have any medical or technical background. A physician might have an idea, stemming from a need she needs to fill, but her background is in medicine and not electronics. Design firms have a lot of work to do before that can take a client to step one.
“A lot of what we do is educate our clients,” said Slate, also an electrical engineer at Fallbrook Engineering. “We ask questions they haven’t even thought of. They have an idea of what they’re looking for, but don’t understand all the thinking that you have to put into it to really identify what needs the technology will have to meet, what the regulatory implications are, and whether their product would qualify for reimbursement.”
About a decade ago, Fallbrook’s engineering team faced a challenge where a client came to the company with an idea that required the development of totally new science. The project was for “partial liquid ventilation” of the lungs.
“They would fill a patient’s lung with a liquid material that would transport oxygen and carbon dioxide while the patient was on a ventilator,” said Meyst of the project. “The client had goals for the project but for us to do the design, we had to develop basic research methods to characterize this particular liquid that would then allow us to do the engineering. It was basic science that didn’t exist—or at least the knowledge was not available to our team—and before we could get to the design and find a solution to the problem we had to spend a significant amount of time just developing a basic understanding of the material.”
And does the Fallbrook Engineering design team face pushback from clients when they learn how much work has to be done before they even start the design process? Only all the time, laughed Meyst.
From Claude’s perspective, clients today know less than they ever have before.
“Our approach with new clients has changed a little bit,” Claude said. “Clients used to have a fully defined device, they knew how it would be used, and the specifications were really highly developed. Now, there are many more business considerations that need to be addressed in today’s product development programs, and this requires a more diligent planning effort than in years past. So we start with an analysis of what the business case is for the product. The product has to find a patient, it has to find a provider, and it has to be paid for by a payor. So all three of those things have to come together for that product to be viable. So we start by looking at the business case for the products itself and how those three stakeholders are going to come together to use that product. It starts from that business case analysis. We then start looking at how that product is going to be used; from there, that evolves into understanding the specific technical requirements and the usability requirements for the product as well as the softer side, the ‘user experience,’ which has become so important in the iPhone age. Both patient and provider want to have an excellent experience using the product. All of that drives towards defining the specifications—and then you can go back to the more traditional product development approach and start from the beginning.”
Traditional product development usually begins with a considerable amount of market research.
“In general, we will conduct market research to gather more information, aiming at identifying the current market trends,” said Enterprise’s Tam. “With all information available, a team of experts will gather together to evaluate if a device is feasible or not. In doing the evaluation, we will need to consider the target market, the intended user, rules and regulations, safety and compliance, cost of development and the product, etc.”
And it’s not only the market that needs to be researched. Markets are made up of users, and that’s where Farm Design focuses its initial research.
“Our process is very user centric, so we usually start by trying to do user research and trying to understand unmet needs,” O’Sullivan explained. “Then we work through the entire workflow from a very holistic standpoint. We look at the entire system and the environment in which it will be used; any trends in the types of activities that they’re doing within the system; and whether there are neighboring systems. We go back to our clients and discuss whether the technology is actually solving the right problem or whether the problem we’re addressing is bigger or different than they’re actually coming to us with. So doing user research and tapping those unmet needs allow us to brainstorm or create concepts for the right problem. The starting point is identifying that we’re actually solving the right problem, which can be a pretty important part of the process.”
The key, as most engineers and design teams will say, is understanding that problem-solving comes from unexpected avenues. Despite medical device design requires collaboration between engineers and experts in various scientific fields, creativity is the most important part of the process.
“The important thing about design is that it is a collaborative approach,” said Meyst. “It’s important to get complementary viewpoints early on so as not to be led down dead ends.”
But that will not be enough to guarantee the safety of future visitors. The internationally used symbol for radioactivity is the trefoil symbol—a dot surrounded by three blades—indicating not to proceed any further for one’s own safety. The question is whether that symbol, or any other symbol in any color we can conceive of, will be certain to convey its message unequivocally to any being that comes across it. In May 2006, Salt Lake City, Utah-based writer and programmer Alan Bellows articulated the issue the DOE faced and still faces today:
“If you look at it just right, the universal radiation warning symbol looks a bit like an angel,” Bellows wrote for the popular science website damninteresting.com. “The circle in the middle could indicate the head, the lower part might be the body, and the upper two arms of the trefoil could represent the wings. Looking at it another way, one might see it as a wheel, a triangular boomerang, a circular saw blade, or any number of relatively benign objects. Whatever a person’s first impression of it may be, someone unfamiliar with the symbol probably wouldn’t guess that it means ‘Danger!’”
In a world that is now irreversibly globalized and, figuratively speaking, smaller than ever, design professionals face the “lost in translation” issue every single day. How do you design a medical device whose function will easily be understood by Americans, Danes, and Chinese? How do you word an instruction so that it will be translatable from Italian to Korean with its key concepts preserved? If a button is tinted green, will that read as “safe” in non-Western cultures? These seemingly small considerations plague medical device designers who are building technologies that must be used correctly—patients’ lives depend on it.
Dan O’Sullivan, director of design for FARM Design Inc., a Hollis, N.H.-based product development company, recalled a glucometer his company designed that was going to be used in Japan. The device had icons on it to indicate how to use it before and after meal times. FARM chose a whole apple to indicate use before a meal, and an apple with bites taken out of it to indicate use post-meal.
“When we showed the apple core with the bites around it in Japan, they didn’t know what that was because they don’t eat an apple like that,” O’Sullivan told Medical Product Outsourcing. “They don’t bite into an apple and leave a big tooth mark. They cut it up and dice it up into small pieces. Within the context of that medical device in that country, that icon didn’t make any sense to them. We would either have to make one specifically for Japan, or try to come up with something different that wouldn’t cause that same problem.”
There is no comprehensive, universal set of symbols that medtech designers can refer to when considering placing instructional iconography on a device’s hardware. The Society for Environmental Graphic Design and Hablamos Juntos, a non-profit organization aimed at improving healthcare communication for Latinos, joined to create a system of symbols that indicate items such as “ambulance,” “emergency,” and various hospital departments. This is one of the only sets of standard healthcare-related iconography, and it is not very helpful to medical device designers. In fact there is no useful set of icons, whether universal or even region-specific, that can be used effectively by medical device designers, O’Sullivan noted.
“What we try to do is look at the context of the system that we’re designing,” said O’Sullivan. “What are the other systems that healthcare professionals or patients might use so that we understand what they’re familiar with? Then we’ll try to draw conclusions on whether there’s familiarity between different countries or areas and design for that. In one example, we were working on a diagnostic lab device, and we were trying to create this magical collection of universal iconography. We determined that there were a certain amount of things that the systems around them do: They all check for patient identification; they have a task list; they test workflow; they run a test; they stop a test; there’s an error warning. Those are what we call system independent iconography. And then there’s system dependent iconography. In this particular example, there was a very unique reagent bottle that we designed for this system. The average person who looked at it would have no idea what it was, so it was not very universal, but it was very specific to the context of this product if you were a trained user. So we developed two different sets of icons: one that was more universal, perhaps understandable by the average person outside of the context of the device; and a whole set that was more specific to the physical form, colors and relationships that were associated with that actual device.”
As Costs Are Forced Down, Complex Tech Trends Up
One natural trend that has emerged from globalization and the boom in personal technology is the rise in telehealth. This, in turn, is connected to the trend toward home use devices—which today, can mean an app on an iPhone—which keep patients out of the hospital and, consequently, keep health care costs down. Also on the rise are wirelessly accessible devices, which enables physicians to conduct check ups remotely.
“Because cell phones are ubiquitous, and the fact that it’s so easy to create apps and add small accessories to a given instrument, you all of a sudden now have a diagnostic device in your hands at a very low cost,” said O’Sullivan. “It would allow a physician to have more frequent check-ins or even patient monitoring at a very low cost, without requiring as many visits to the hospital or the clinic.”
In the midst of the trend towards wireless technology and telehealth, the U.S. Food and Drug Administration (FDA) has been dragging its feet on establishing regulations on cybersecurity. As the issue creeps to the forefront, the agency has issued various guidances to help device manufacturers implement protections for their devices.
According to the agency, the general principles device manufacturers should keep in mind are confidentiality, integrity and availability. Confidentiality means that data, information, or system structures are accessible only to authorized persons and entities and are processed at authorized times and in the authorized manner, thereby helping ensure data and system security. Confidentiality provides the assurance that no unauthorized user has access to the data, information, or system structures. Integrity means that data and information are accurate and complete and have not been improperly modified. Availability means that data, information, and information systems are accessible and usable on demand.
MPR Associates Inc., located in the FDA’s backyard of Alexandra, Va., has put together comprehensive approaches to cybersecurity for devices they design that include software or other vulnerable wireless technologies. General Manager of product development Eric Claude detailed three of the top ways in which MPR protects its wirelessly capable devices.
The first is managing the “directionality of communication.” The device is set up so that it only communicates data outwards, and is incapable of receiving data of any kind.
“In some applications there is actually a benefit for devices being able to receive data,” Claude said. “For example, loading updated firmware or software onto a device. That clearly opens you up to a bigger risk, so it’s important for device developers to recognize the risks associated with that kind of functionality.”
The second approach is “segregation.” Two entirely different processors exist in the device. One manages the outgoing and/or incoming communication, while the other manages the function of the device. Claude described it as “two separate computers running side by side doing different things”.
The third approach—and MPR has more under its belt, but these are the three main ones—is to implement a proprietary or high-security communication protocol.
“It’s like I’m speaking my own language to my computers and they don’t understand anybody else’s language.”
“The whole issue of security is obviously a big one, and we do seem to be on the forefront of who’s going to take the first leap; who’s going to blaze that trail, go up against the FDA and put a system in place that is secure enough,” O’Sullivan said. “A lot of the smaller companies are probably holding back a little bit, waiting to see who’s going to spend the most money to blaze that trail, and then there may be many who are quick to follow.”
While the FDA has not yet come up with clear guidelines on cybersecurity, it certainly will eventually. Claude stressed the importance of implementing compliance and risk mitigation strategies sooner rather than later in anticipation of regulation.
“Unless your device has no electronics whatsoever, you must have something in your risk analysis and product specifications about cybersecurity issues, because the FDA is going to look for it,” warned Claude. “The way we approach it is that our risk analysis drives the strategy. We look at how a device is going to be used or misused, what the risks are, and how you deal with them. So when FDA asks how are you dealing with cybersecurity, the first thing you do is you break out your risk analysis and you point them to that section and your show them what you’re doing.”
The hope that the increase in telehealth and other wireless technologies will keep costs down is a fervent one.
“Nowadays, the cost of going to the hospital for treatment or any services is relatively expensive,” said Joe Tam, senior manager of the R&D department for contract design and manufacturer Providence Enterprise LLC. “It will be time consuming and inconvenient for elderly people to visit the doctor. Also, a huge amount of money is required to build more hospitals to fulfill and accommodate the growing aging population.”
In fact, John Slate, Ph.D., senior systems engineer from Escondido, Calif.-based Fallbrook Engineering Inc., was faced with a startling realization at a recent conference sponsored by the National Institutes of Health. A venture capital investor speaking at the conference said that a full two thirds of both people with investment money looking for funding opportunities and the funding itself are gone from the medtech market—permanently.
“Most of the funding that is being reported is going into follow-on rounds as opposed to new startups. The medical space is not as much of a financial gold mine as it used to be,” Slate said. “The medical device tax has really hurt the industry; getting regulatory approval in a timely fashion has been difficult; the time from inception to market is longer than it used to be; and the bar that you have to get over to show that your product meets all the requirements has become more difficult.”
While many companies have noticed a significant trend towards software and telehealth technologies, Fallbrook Engineering has noticed an uptick in bioresorbables. In a way connected with the increasing capabilities engineers have as technology advances, expensive, highly complicated bioresorbable materials are rising in demand.
“Bioresorbables have been around for more than 20 years,” said Richard Meyst, president and principal consultant for Fallbrook Engineering. “The materials are very expensive, but interest in them is rising both from designers and medical device companies. This is partly due to media exposure, which has made people aware of them again, but also because they can solve a lot of difficult problems traditional materials cannot.”
Meyst went on to say that while they are very useful medical materials, bioresorbables are not easy to engineer and require very advanced technical expertise. Drug eluting stents, for instance, must emit a very specific dose of drug over a specific amount of time in regulated doses.
“Designing something to last only as long as you want it to is not easy,” Meyst said.
New Approaches to Design
In light of how quickly telehealth—also known by connected health, e-health, health IT, and various other monikers—is growing, contract design firms are noticing a shift in how design clients approach new devices.
One of the most basic medical devices that we still use today is the hypodermic needle and syringe. The device was invented in 1853. Dr. Alexander Wood is credited for the invention. He had been experimenting with a hollow needle to administer drugs, and he eventually felt confident enough in his approach to publish a short paper in the Edinburgh Medical and Surgical Journal called “A New Method of treating Neuralgia by the direct application of Opiates to the Painful Points.”
Before the advancement of technology started accelerating at breakneck speeds somewhere in the late 20th century, conceiving an idea and fashioning a rudimentary medical device was simple. Today, when an idea is born, it can come from various avenues. An entrepreneur might have an idea, but she may not have any medical or technical background. A physician might have an idea, stemming from a need she needs to fill, but her background is in medicine and not electronics. Design firms have a lot of work to do before that can take a client to step one.
“A lot of what we do is educate our clients,” said Slate, also an electrical engineer at Fallbrook Engineering. “We ask questions they haven’t even thought of. They have an idea of what they’re looking for, but don’t understand all the thinking that you have to put into it to really identify what needs the technology will have to meet, what the regulatory implications are, and whether their product would qualify for reimbursement.”
About a decade ago, Fallbrook’s engineering team faced a challenge where a client came to the company with an idea that required the development of totally new science. The project was for “partial liquid ventilation” of the lungs.
“They would fill a patient’s lung with a liquid material that would transport oxygen and carbon dioxide while the patient was on a ventilator,” said Meyst of the project. “The client had goals for the project but for us to do the design, we had to develop basic research methods to characterize this particular liquid that would then allow us to do the engineering. It was basic science that didn’t exist—or at least the knowledge was not available to our team—and before we could get to the design and find a solution to the problem we had to spend a significant amount of time just developing a basic understanding of the material.”
And does the Fallbrook Engineering design team face pushback from clients when they learn how much work has to be done before they even start the design process? Only all the time, laughed Meyst.
From Claude’s perspective, clients today know less than they ever have before.
“Our approach with new clients has changed a little bit,” Claude said. “Clients used to have a fully defined device, they knew how it would be used, and the specifications were really highly developed. Now, there are many more business considerations that need to be addressed in today’s product development programs, and this requires a more diligent planning effort than in years past. So we start with an analysis of what the business case is for the product. The product has to find a patient, it has to find a provider, and it has to be paid for by a payor. So all three of those things have to come together for that product to be viable. So we start by looking at the business case for the products itself and how those three stakeholders are going to come together to use that product. It starts from that business case analysis. We then start looking at how that product is going to be used; from there, that evolves into understanding the specific technical requirements and the usability requirements for the product as well as the softer side, the ‘user experience,’ which has become so important in the iPhone age. Both patient and provider want to have an excellent experience using the product. All of that drives towards defining the specifications—and then you can go back to the more traditional product development approach and start from the beginning.”
Traditional product development usually begins with a considerable amount of market research.
“In general, we will conduct market research to gather more information, aiming at identifying the current market trends,” said Enterprise’s Tam. “With all information available, a team of experts will gather together to evaluate if a device is feasible or not. In doing the evaluation, we will need to consider the target market, the intended user, rules and regulations, safety and compliance, cost of development and the product, etc.”
And it’s not only the market that needs to be researched. Markets are made up of users, and that’s where Farm Design focuses its initial research.
“Our process is very user centric, so we usually start by trying to do user research and trying to understand unmet needs,” O’Sullivan explained. “Then we work through the entire workflow from a very holistic standpoint. We look at the entire system and the environment in which it will be used; any trends in the types of activities that they’re doing within the system; and whether there are neighboring systems. We go back to our clients and discuss whether the technology is actually solving the right problem or whether the problem we’re addressing is bigger or different than they’re actually coming to us with. So doing user research and tapping those unmet needs allow us to brainstorm or create concepts for the right problem. The starting point is identifying that we’re actually solving the right problem, which can be a pretty important part of the process.”
The key, as most engineers and design teams will say, is understanding that problem-solving comes from unexpected avenues. Despite medical device design requires collaboration between engineers and experts in various scientific fields, creativity is the most important part of the process.
“The important thing about design is that it is a collaborative approach,” said Meyst. “It’s important to get complementary viewpoints early on so as not to be led down dead ends.”