"The number-one issue among packaging engineers continues to be cost reduction," says Larsen. "Companies are trying to wring out costs from packaging. That's due to a couple of reasons. First is a belief among some that packaging is something nearly anybody can do and understand. Second is a belief that packaging is free, or that you run down to the corner store and just buy pouches off the shelf. Some people either don't have an appreciation for the science of medical device packaging, or they view it as a necessary evil."
Device packaging lags behind
Perhaps it's a generalization, but there's an impression among some people that the medical device sector lags behind pharmaceuticals and food when it comes to packaging. "There's no doubt about it," Larsen states.
"Food packaging helps sell the product. I worked at Pillsbury and if you could wring a fraction of a cent out of a cake-mix package, for example, you could save the company millions of dollars. In the medical device industry, they really don't practice concurrent engineering during the new product development cycle. The focus is on device development. Some companies don't understand that the device has to be packaged, and sterilized, and have all the appropriate labeling information."
Without such information on their packages, Larsen says a company would be in violation of the U.S. FDA regulatory requirements. He adds, "That's when the feds and regulatory agencies come down on you, and it can cost your company a lot of money. People don't understand or give any credibility to the science of packaging in our industry, whereas in over-the-counter drugs, prescription pharmaceuticals, and foods, packaging is a key."
Asked to elaborate, Larsen says: "In pharmaceuticals, they understand the role packaging plays in protecting the fragile contents of the medication. And, pharmaceuticals have been regulated for a lot longer than medical devices, so right from the start, their industry understood the critical role packaging played in the life-cycle of the drug."
For medical devices, Larsen says that "there are so many different fragility issues to deal with, such as shock and vibration, and maintaining sterility and product performance, from the point of manufacture all the way until the device gets to the operating room or into the end-user's hands." He explains, "The end user in most cases is not a doctor. It's usually a nurse. Nurses are the people who actually handle our industry's packages, open them up, swear at them, and eventually discard them."
The ongoing engineering/marketing challenge
Another issue device makers have faced for some time "is that if a company is lucky enough to have packaging engineers, those engineers hardly ever get to talk to the customer," says Larsen. "Engineers are always dealing with marketing or sales support. If an engineer indicates he or she would like to talk to a customer about packaging issues, marketing people would likely say, 'We know what those issues are.' Well, engineers don't know if they do or not. That's a packaging problem."
With the different perspectives from engineers and marketers, how does a company design and produce a package that both departments can agree upon?
"It's an issue that's always existed," says Spitzley. "It's becoming more critical because packaging engineers never hear first-hand about the customer's needs. Also, there are not enough educated and experienced packaging engineers working in the medical device industry. They package by committee or hand it off to someone who they think has some time to devote to the issue. They move from one product's development to another and to the next, within the same organization. They are singing out of totally different songbooks, doing things differently. They don't have that focus within the corporation."
Spitzley and Larsen see a lack of focus on a product's specific packaging requirements. That's especially so as combination products evolve. "Whether it's sterility, keeping a device dry during its expected life, or maintaining a certain moisture level, different barrier requirements have to be met depending on the fragility of the device," notes Larsen.
11607 to the rescue
Spartan Design Group encourages device packagers to rely on the updated AAMI/ANSI/ISO 11607-1 and -2 (www.aami.org). The revised documentation, says Spitzley, "is a comprehensive global standard for medical device packaging. It was first published in 1997, at the same time that EN-868-1 [the European standard] came out. Until then, there were general requirements from the Food and Drug Administration's Center for Devices and Radiological Health (www.fda.gov/cdrh), from their Good Manufacturing Practices (www.fda.gov/cdrh/devadvice/32.html), and some regional international requirements." The recently published ISO standard 11607-1 and 11607-2 are the only global harmonized standards that detail all the requirements for selecting materials, and designing, developing, testing, and manufacturing a packaging system for medical devices," says Spitzley.
He adds, "If you read through the standards and conform to all the "shall-statements" [requirements], you meet the global requirements for your medical device packaging." He explains that these shall statements are requirements, different than words such as "should," "may," or "consider." Both Spitzley and Larsen point out that ISO 11607-1 and 2 is a voluntary standard.
"All ISO standards are voluntary in the United States, but in Europe, you do have to comply," with EN ISO 11607-1:2006 and –2:2006, says Spitzley. "In the U.S., we have GMPs and laws that we have to meet, but ISO standards are designed as a tool that you can use, and they're recognized by the FDA," notes Larsen.
Device makers and the FDA
Do medical device manufacturers generally view the FDA as a regulating body, or do they perceive the agency as a hindrance?
Spitzley suggests, "it's not that the manufacturers view the FDA as an adversary, it's that FDA inconsistencies scare them." Device makers are concerned, he says, "because they don't always know what to expect when they put in a PMA submission or a 510k. They don't know what packaging questions the FDA is going to ask."
Larsen says, "There are no experienced medical device packaging engineers within the FDA. There are different responses [from FDA inspectors] in different regions.
"That's why it's so important for companies to do a self-audit or a self-check on compliance with the 11607-1 and 2 standard. If you go through that process and find out that you are in compliance, then you are pretty much home-free," when it comes to satisfying FDA requirements.
But when a manufacturer launches a new product or develops a new packaging line, wouldn't it make sense for them to consult the FDA upfront for guidance?
"The FDA is not going to act as a consultant and advise what to do," says Spitzley. "They will ask you to provide information or data demonstrating that you have met requirements, and then tell you they will come back to check and see if you have. There are guidance documents on their Web site and you can look at those, but I think a lot of them are outdated and have little relevance to medical device packaging."
Larsen and Spitzley believe that industry is in a position to help train the FDA in some instances. That could be especially helpful in creating a broader understanding that FDA inspectors can apply more evenly throughout the U.S.
Testing issues
Spitzley voices another growing concern within the medical device packaging community: "We are finding out that there is inappropriate and/or excessive testing going on regarding medical device packaging,"
he says. "Sometimes it exceeds what is required and realistic, and companies are experiencing a lot of false failures.
"We like to call these self-inflicted wounds. There is so much of that going on just because people don't understand standards. They are using tests that have fallen from grace years ago. But yet they have used them for years and years and regulatory affairs or quality personnel say, 'I am not going to change these submissions. It worked then and it's going to work now. Don't try to change that!'"
Larsen adds that some of these companies conduct tests for different attributes just because they are in a hurry and they are trying to save time and money. "They basically beat on these packages," he says, "and when they get a failure, they don't understand how that could happen."
Of course, excess testing typically results in manufacturers spending more money, which goes against the effort to control costs.
"They shoot themselves in the foot," says Larsen, "and as a result, they have to go back and make changes, and they've got to explain these failures to management."
Testing recommendations
So what steps can a manufacturer take to avoid the pitfalls of inappropriate or excessive medical device package testing? Beyond understanding the 11607 documents, Larsen suggests the Technical Information Report (TIR) 22. It's published in the U.S. by the Association for Advancement of Medical Instrumentation (www.aami.org).
"It guides you through what you need to consider to meet all U.S. requirements," he says. "There is a revision out to match up with the latest revisions of AAMI/ANSI/ISO 11607-1:2006 and AAMI/ANSI/ISO 11607-2:2006. And there is another revision that's being worked on that incorporates what the hospitals need to consider."
Larsen advises packaging professionals in the medical device sector to become active within standard-setting organizations such as ASTM Intl. (www.astm.org), an open forum for the development of high-quality, market-relevant international standards used around the globe. ASTM's FO2 Flexible Barrier Packaging Committee addresses medical device packaging needs.
HealthPack conference
Attending the yearly HealthPack conference (www.healthpack.net) is another educational opportunity for device makers, say Spitzley and Larsen, who are program co-chairs for the event and develop the agenda. "At HealthPack 2008, the keynote speaker will be Mary Jo Steiert, president of AORN, the Association of periOperative Registered Nurses (www.aorn.org)," says Larsen.
Steiert will address her membership's needs, issues, and requirements for medical device packaging, including safety and sterility considerations, packaging efficacy in operating room and emergency situations, and package integration in the OR.
Larsen says that HealthPack 2008 attendees will be presented with the results of a custom research survey sent to thousands of AORN members and Institute of Packaging Professionals (www.iopp.org) Medical Device Packaging Technical Committee members.
Adds Spitzley, "This is going to be the perfect opportunity for attendees to hear the voice of the customer using a controlled, scientific approach. We think the survey results are going to be pretty eye-opening."
Manufacturing costs
With some high-volume, low-margin medical devices such as gauze, gloves, or tubing sets, Larsen says, "engineers look at ways of improving efficiency, [often using] high-speed form/fill/seal machines. But where the disconnect happens is with low-volume, high-margin and high-cost devices where packaging is a secondary cost." In these instances, he says, the approach taken all too often is 'Oh yes, we've got to put a package around this.'"
Spitzley adds, "Some companies develop the package along with the device, but what are you going to do about packaging costs when you are packaging high-value defibrillators, and you only make 20,000 of them a year?"
The concern here is that if companies scrimp on their packaging efforts, it could adversely affect the device. With these products typically enjoying high profit margins, Larsen recommends that you "give them the Cadillac of packaging." He says, "You want to be sure that the package contents get to the end user in perfect shape."
Saving and consolidating
It's not uncommon for manufacturers of such high-end devices to make another mistake. Spitzley explains that a company may make defibrillators "in different locations, with different models. Each model will look different, and each facility may use different packaging approaches. Some may use a tray, a clamshell, and a pouch, while others may use a double-thermoformed tray, and some a single tray. In a lot of cases companies could consolidate suppliers and simplify designs, resulting in cost savings."
From a regulatory standpoint, Spitzley notes: "You can satisfy requirements and be diligent that way, but not be efficient in developing the design.
A better approach, for example, would be to develop packaging systems that are designed to accommodate a family of products no matter where they are manufactured.
Larsen offers two additional tips:
• Buying in volume. "Don't buy all your corrugated boxes at one facility and ship them around the world. That's just not practical. But for Tyvek lids or pouches, you can buy them from one vender if they fit the trays, and ship them economically."
• Machinery purchases. "You need to be able to justify costs based on benefits to determine payback. Some people are not aware of some of the equipment that's out there. For example, there's intermediate or semi-automatic equipment positioned between manual operations and high-speed, high-output equipment that can provide the option of buying a $30,000 pouch sealer that can print information onto rollstock rather than investing in a half-a-million dollar machine."
Packaging paramedics
At Spitzley and Larsen's Spartan Design Group, they are often called in emergency situations, to help extinguish customer fires. A typical situation is a company whose device packaging is found to be unsatisfactory as the product's launch date nears.
"We advise companies to consider how they test the package, what kinds of tools they need to evaluate the integrity of a sterile barrier system, and what they need to consider when designing a package, taking into account the fragility issues pertaining to the device itself," says Larsen. "It's critical that they understand how the package will be used, what equipment needs to be purchased, and how to work with the material suppliers. Protocols and plans for critical process validation, packaging system design qualification, and Sterile Barrier System stability must also be developed."
Material developments
Asked about future packaging material advances for medical devices, Larsen is upbeat. "There is development work being done on what we call 'bulletproof film' such as seven-layer coextrusions and film that's much tougher than the old workhorse 48-gauge polyester/2-mil low-density polyethylene pouch," he says.
He says these films can not only withstand different types of sterilization, but they can also provide ample puncture strength and abrasion-resistance. Manufacturers are introducing more robust film combinations, but companies may need to consider rigid materials as well.
By Jim Butschli, Editor
Device packaging lags behind
Perhaps it's a generalization, but there's an impression among some people that the medical device sector lags behind pharmaceuticals and food when it comes to packaging. "There's no doubt about it," Larsen states.
"Food packaging helps sell the product. I worked at Pillsbury and if you could wring a fraction of a cent out of a cake-mix package, for example, you could save the company millions of dollars. In the medical device industry, they really don't practice concurrent engineering during the new product development cycle. The focus is on device development. Some companies don't understand that the device has to be packaged, and sterilized, and have all the appropriate labeling information."
Without such information on their packages, Larsen says a company would be in violation of the U.S. FDA regulatory requirements. He adds, "That's when the feds and regulatory agencies come down on you, and it can cost your company a lot of money. People don't understand or give any credibility to the science of packaging in our industry, whereas in over-the-counter drugs, prescription pharmaceuticals, and foods, packaging is a key."
Asked to elaborate, Larsen says: "In pharmaceuticals, they understand the role packaging plays in protecting the fragile contents of the medication. And, pharmaceuticals have been regulated for a lot longer than medical devices, so right from the start, their industry understood the critical role packaging played in the life-cycle of the drug."
For medical devices, Larsen says that "there are so many different fragility issues to deal with, such as shock and vibration, and maintaining sterility and product performance, from the point of manufacture all the way until the device gets to the operating room or into the end-user's hands." He explains, "The end user in most cases is not a doctor. It's usually a nurse. Nurses are the people who actually handle our industry's packages, open them up, swear at them, and eventually discard them."
The ongoing engineering/marketing challenge
Another issue device makers have faced for some time "is that if a company is lucky enough to have packaging engineers, those engineers hardly ever get to talk to the customer," says Larsen. "Engineers are always dealing with marketing or sales support. If an engineer indicates he or she would like to talk to a customer about packaging issues, marketing people would likely say, 'We know what those issues are.' Well, engineers don't know if they do or not. That's a packaging problem."
With the different perspectives from engineers and marketers, how does a company design and produce a package that both departments can agree upon?
"It's an issue that's always existed," says Spitzley. "It's becoming more critical because packaging engineers never hear first-hand about the customer's needs. Also, there are not enough educated and experienced packaging engineers working in the medical device industry. They package by committee or hand it off to someone who they think has some time to devote to the issue. They move from one product's development to another and to the next, within the same organization. They are singing out of totally different songbooks, doing things differently. They don't have that focus within the corporation."
Spitzley and Larsen see a lack of focus on a product's specific packaging requirements. That's especially so as combination products evolve. "Whether it's sterility, keeping a device dry during its expected life, or maintaining a certain moisture level, different barrier requirements have to be met depending on the fragility of the device," notes Larsen.
11607 to the rescue
Spartan Design Group encourages device packagers to rely on the updated AAMI/ANSI/ISO 11607-1 and -2 (www.aami.org). The revised documentation, says Spitzley, "is a comprehensive global standard for medical device packaging. It was first published in 1997, at the same time that EN-868-1 [the European standard] came out. Until then, there were general requirements from the Food and Drug Administration's Center for Devices and Radiological Health (www.fda.gov/cdrh), from their Good Manufacturing Practices (www.fda.gov/cdrh/devadvice/32.html), and some regional international requirements." The recently published ISO standard 11607-1 and 11607-2 are the only global harmonized standards that detail all the requirements for selecting materials, and designing, developing, testing, and manufacturing a packaging system for medical devices," says Spitzley.
He adds, "If you read through the standards and conform to all the "shall-statements" [requirements], you meet the global requirements for your medical device packaging." He explains that these shall statements are requirements, different than words such as "should," "may," or "consider." Both Spitzley and Larsen point out that ISO 11607-1 and 2 is a voluntary standard.
"All ISO standards are voluntary in the United States, but in Europe, you do have to comply," with EN ISO 11607-1:2006 and –2:2006, says Spitzley. "In the U.S., we have GMPs and laws that we have to meet, but ISO standards are designed as a tool that you can use, and they're recognized by the FDA," notes Larsen.
Device makers and the FDA
Do medical device manufacturers generally view the FDA as a regulating body, or do they perceive the agency as a hindrance?
Spitzley suggests, "it's not that the manufacturers view the FDA as an adversary, it's that FDA inconsistencies scare them." Device makers are concerned, he says, "because they don't always know what to expect when they put in a PMA submission or a 510k. They don't know what packaging questions the FDA is going to ask."
Larsen says, "There are no experienced medical device packaging engineers within the FDA. There are different responses [from FDA inspectors] in different regions.
"That's why it's so important for companies to do a self-audit or a self-check on compliance with the 11607-1 and 2 standard. If you go through that process and find out that you are in compliance, then you are pretty much home-free," when it comes to satisfying FDA requirements.
But when a manufacturer launches a new product or develops a new packaging line, wouldn't it make sense for them to consult the FDA upfront for guidance?
"The FDA is not going to act as a consultant and advise what to do," says Spitzley. "They will ask you to provide information or data demonstrating that you have met requirements, and then tell you they will come back to check and see if you have. There are guidance documents on their Web site and you can look at those, but I think a lot of them are outdated and have little relevance to medical device packaging."
Larsen and Spitzley believe that industry is in a position to help train the FDA in some instances. That could be especially helpful in creating a broader understanding that FDA inspectors can apply more evenly throughout the U.S.
Testing issues
Spitzley voices another growing concern within the medical device packaging community: "We are finding out that there is inappropriate and/or excessive testing going on regarding medical device packaging,"
he says. "Sometimes it exceeds what is required and realistic, and companies are experiencing a lot of false failures.
"We like to call these self-inflicted wounds. There is so much of that going on just because people don't understand standards. They are using tests that have fallen from grace years ago. But yet they have used them for years and years and regulatory affairs or quality personnel say, 'I am not going to change these submissions. It worked then and it's going to work now. Don't try to change that!'"
Larsen adds that some of these companies conduct tests for different attributes just because they are in a hurry and they are trying to save time and money. "They basically beat on these packages," he says, "and when they get a failure, they don't understand how that could happen."
Of course, excess testing typically results in manufacturers spending more money, which goes against the effort to control costs.
"They shoot themselves in the foot," says Larsen, "and as a result, they have to go back and make changes, and they've got to explain these failures to management."
Testing recommendations
So what steps can a manufacturer take to avoid the pitfalls of inappropriate or excessive medical device package testing? Beyond understanding the 11607 documents, Larsen suggests the Technical Information Report (TIR) 22. It's published in the U.S. by the Association for Advancement of Medical Instrumentation (www.aami.org).
"It guides you through what you need to consider to meet all U.S. requirements," he says. "There is a revision out to match up with the latest revisions of AAMI/ANSI/ISO 11607-1:2006 and AAMI/ANSI/ISO 11607-2:2006. And there is another revision that's being worked on that incorporates what the hospitals need to consider."
Larsen advises packaging professionals in the medical device sector to become active within standard-setting organizations such as ASTM Intl. (www.astm.org), an open forum for the development of high-quality, market-relevant international standards used around the globe. ASTM's FO2 Flexible Barrier Packaging Committee addresses medical device packaging needs.
HealthPack conference
Attending the yearly HealthPack conference (www.healthpack.net) is another educational opportunity for device makers, say Spitzley and Larsen, who are program co-chairs for the event and develop the agenda. "At HealthPack 2008, the keynote speaker will be Mary Jo Steiert, president of AORN, the Association of periOperative Registered Nurses (www.aorn.org)," says Larsen.
Steiert will address her membership's needs, issues, and requirements for medical device packaging, including safety and sterility considerations, packaging efficacy in operating room and emergency situations, and package integration in the OR.
Larsen says that HealthPack 2008 attendees will be presented with the results of a custom research survey sent to thousands of AORN members and Institute of Packaging Professionals (www.iopp.org) Medical Device Packaging Technical Committee members.
Adds Spitzley, "This is going to be the perfect opportunity for attendees to hear the voice of the customer using a controlled, scientific approach. We think the survey results are going to be pretty eye-opening."
Manufacturing costs
With some high-volume, low-margin medical devices such as gauze, gloves, or tubing sets, Larsen says, "engineers look at ways of improving efficiency, [often using] high-speed form/fill/seal machines. But where the disconnect happens is with low-volume, high-margin and high-cost devices where packaging is a secondary cost." In these instances, he says, the approach taken all too often is 'Oh yes, we've got to put a package around this.'"
Spitzley adds, "Some companies develop the package along with the device, but what are you going to do about packaging costs when you are packaging high-value defibrillators, and you only make 20,000 of them a year?"
The concern here is that if companies scrimp on their packaging efforts, it could adversely affect the device. With these products typically enjoying high profit margins, Larsen recommends that you "give them the Cadillac of packaging." He says, "You want to be sure that the package contents get to the end user in perfect shape."
Saving and consolidating
It's not uncommon for manufacturers of such high-end devices to make another mistake. Spitzley explains that a company may make defibrillators "in different locations, with different models. Each model will look different, and each facility may use different packaging approaches. Some may use a tray, a clamshell, and a pouch, while others may use a double-thermoformed tray, and some a single tray. In a lot of cases companies could consolidate suppliers and simplify designs, resulting in cost savings."
From a regulatory standpoint, Spitzley notes: "You can satisfy requirements and be diligent that way, but not be efficient in developing the design.
A better approach, for example, would be to develop packaging systems that are designed to accommodate a family of products no matter where they are manufactured.
Larsen offers two additional tips:
• Buying in volume. "Don't buy all your corrugated boxes at one facility and ship them around the world. That's just not practical. But for Tyvek lids or pouches, you can buy them from one vender if they fit the trays, and ship them economically."
• Machinery purchases. "You need to be able to justify costs based on benefits to determine payback. Some people are not aware of some of the equipment that's out there. For example, there's intermediate or semi-automatic equipment positioned between manual operations and high-speed, high-output equipment that can provide the option of buying a $30,000 pouch sealer that can print information onto rollstock rather than investing in a half-a-million dollar machine."
Packaging paramedics
At Spitzley and Larsen's Spartan Design Group, they are often called in emergency situations, to help extinguish customer fires. A typical situation is a company whose device packaging is found to be unsatisfactory as the product's launch date nears.
"We advise companies to consider how they test the package, what kinds of tools they need to evaluate the integrity of a sterile barrier system, and what they need to consider when designing a package, taking into account the fragility issues pertaining to the device itself," says Larsen. "It's critical that they understand how the package will be used, what equipment needs to be purchased, and how to work with the material suppliers. Protocols and plans for critical process validation, packaging system design qualification, and Sterile Barrier System stability must also be developed."
Material developments
Asked about future packaging material advances for medical devices, Larsen is upbeat. "There is development work being done on what we call 'bulletproof film' such as seven-layer coextrusions and film that's much tougher than the old workhorse 48-gauge polyester/2-mil low-density polyethylene pouch," he says.
He says these films can not only withstand different types of sterilization, but they can also provide ample puncture strength and abrasion-resistance. Manufacturers are introducing more robust film combinations, but companies may need to consider rigid materials as well.
By Jim Butschli, Editor
![Alison Bryant, senior consultant at Antea Group and communications director for the Healthcare Plastics Recycling Council (HPRC), addressed the crowd at the[PACK]out.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2024/05/Alison_Bryant.6644005a513b0.png?auto=format%2Ccompress&fit=crop&h=167&q=70&w=250)
