Consider potential cybersecurity risks when developing smart devices, says MD&M West speaker

Have you considered cybersecurity risk? FDA has just released the new draft guidance, “Postmarket Management of Cybersecurity in Medical Devices.” 

“A growing number of medical devices are designed to be networked to facilitate patient care,” the agency writes in the draft. “Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats.” 

Should cybersecurity be considered during the development of smart drug-delivery devices? We asked Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, Henry Ford Health, this question and more. He intends to cover traditional medical devices as well as smart drug-delivery devices on Wednesday, February 10 at the upcoming MD&M West 2016 conference in Anaheim, CA.

PMP: Medical device cybersecurity has been identified as a potential concern by FDA. When it comes to developing smart drug-delivery devices (such as devices that may interact with a digital device for tracking dosing or other patient activities), what cybersecurity risks are there, and how can drug and device companies minimize those risks to protect patients?

Youssef: When it comes to developing medical devices, it’s critical for manufacturers to focus on the entire system, taking into account the network environment of a clinic or hospital as well as the clinical efficacy of the device. There are risks associated with the device itself, as well as how the device interacts with the network and the rest of the hospital or clinic ecosystem.  Some of the key areas that are of concern are: 

1) End-users leveraging default, or shared passwords on the device or the network that the device is relying on.

a. Device manufacturers can create workflows to ensure that the passwords in use are sophisticated and difficult to decipher using dictionary attacks.

b. Discourage the use of Pre-shared keys, WEP, or TKIP and rather promote AES encryption and authentication.

2) Patient Data compromised, or intercepted.

a. Ensure that data is encrypted in transit as well as while at rest or being stored on the device.

3) Medical device being susceptible to attack from within or outside the network.

a. Manufacturers can take measures to ensure that only secure protocols are used to access the device configuration.

b. Work with the hospitals and clinics to implement role-based access controls to ensure that a given device can only access what it requires on the hospital or clinic network.

c. Work with the hospital to ensure that a defense in depth strategy is in place to protect medical devices and the data they transmit.

4) Underlying OS vulnerabilities.

a. Manufacturers should move away from using backend Operating Systems that are no longer supported such as Windows XP.

b. Promote regular security patch management.

c. Promote routine security audits.

5) Promoting redundancy.

a. Manufacturers can build a layer of redundancy in the device to ensure that if a given communication medium is disrupted, the device can continue to safely and effectively function.

It is difficult for medical device manufacturers to mimic a hospital network, so every measure should be taken to test the devices on test beds that are configured as closely as possible to a hospital network, or on the hospital network itself.

PMP: Does the concern about cybersecurity only apply to smart medical devices and drug-delivery devices used in hospitals, or would it also be a concern for smart devices that patients use at home (or on the go) that communicate with phone apps? 

Youssef: It’s a concern in both arenas. The challenges are similar from a device security perspective regardless of where it is being used.  When we introduce apps into the equation that adds another layer of complexity and a multitude of additional potential vulnerabilities.

If anything, in a hospital setting, there are usually security measures in place with traffic segmentation onto dedicated VLANs and robust firewalls.  The typical home network environment typically lacks this level of security.

PMP: What can potential attendees expect to learn from your session?

Youssef: This session is intended for medical device manufacturers as well as hospital staff. I will cover typical medical device cybersecurity concerns with a focus on:

1) How device manufacturers can help alleviate some of these, and

2) How healthcare workers can take proactive measures to identify cybersecurity issues.

PMP: What actions do you hope attendees will take after attending your session?

Youssef: My hope is that medical device manufacturers will make an effort towards establishing test beds that are more IT network focused. The other side of this is to ensure that health systems implement robust test processes and device onboarding processes to try and proactively isolate potential security issues.

Here are details on Youssef’s presentation as well as those from a few other speakers at MD&M West (Feb. 9-11; Anaheim, CA):

Wednesday, February 10

1:25 pm -1:50 pm 
Assessing Medical Device Cyber Risk in Your Connected Device

  • Recognizing various security threats to integrated medical devices
  • Listing controls relevant to a medical device IT security assessment
  • Exploring ways to manage risk when there is a cyber-security issue

Ali Youssef, Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM

1:50 pm – 2:30 pm
 Panel: Managing Risk to Keep Data Secure and Patients Safe

  • Overcoming the 3 main risk areas: patient safety, malicious activity, and data security
  • Factors to consider during product design with an eye toward cyber security
  • Recognizing cultural challenges such as availability vs. confidentiality of data and how to effectively deal with these in your organization

Moderator: Andrew Herger, Director of Engineering-IoT, DEDICATED COMPUTING

Michelle Longmire, MD, Founder, MEDABLE


Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM


Melissa Masters, RAC, Manager, Electrical, Software and Systems Engineering; Director, BATTELLE DEVICE SECURE SERVICES, BATTELLE 

 

Also, FDA had held a public workshop on cybersecurity on January 20-21, 2016, entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” It was held in collaboration with the National Health Information Sharing Analysis Center, the Department of Health and Human Services, and the Department of Homeland Security.

According to FDA’s draft guidance, “Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.”

Please click here for more details on attending MD&M West 2016.

 

Source Article from http://www.packagingdigest.com/patient-safety/pmp-consider-potential-cybersecurity-risks-when-developing-smart-devices-says-mdm-west-speaker-160129

Consider potential cybersecurity risks when developing smart devices, says MD&M West speaker

Have you considered cybersecurity risk? FDA has just released the new draft guidance, “Postmarket Management of Cybersecurity in Medical Devices.” 

“A growing number of medical devices are designed to be networked to facilitate patient care,” the agency writes in the draft. “Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats.” 

Should cybersecurity be considered during the development of smart drug-delivery devices? We asked Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, Henry Ford Health, this question and more. He intends to cover traditional medical devices as well as smart drug-delivery devices on Wednesday, February 10 at the upcoming MD&M West 2016 conference in Anaheim, CA.

PMP: Medical device cybersecurity has been identified as a potential concern by FDA. When it comes to developing smart drug-delivery devices (such as devices that may interact with a digital device for tracking dosing or other patient activities), what cybersecurity risks are there, and how can drug and device companies minimize those risks to protect patients?

Youssef: When it comes to developing medical devices, it’s critical for manufacturers to focus on the entire system, taking into account the network environment of a clinic or hospital as well as the clinical efficacy of the device. There are risks associated with the device itself, as well as how the device interacts with the network and the rest of the hospital or clinic ecosystem.  Some of the key areas that are of concern are: 

1) End-users leveraging default, or shared passwords on the device or the network that the device is relying on.

a. Device manufacturers can create workflows to ensure that the passwords in use are sophisticated and difficult to decipher using dictionary attacks.

b. Discourage the use of Pre-shared keys, WEP, or TKIP and rather promote AES encryption and authentication.

2) Patient Data compromised, or intercepted.

a. Ensure that data is encrypted in transit as well as while at rest or being stored on the device.

3) Medical device being susceptible to attack from within or outside the network.

a. Manufacturers can take measures to ensure that only secure protocols are used to access the device configuration.

b. Work with the hospitals and clinics to implement role-based access controls to ensure that a given device can only access what it requires on the hospital or clinic network.

c. Work with the hospital to ensure that a defense in depth strategy is in place to protect medical devices and the data they transmit.

4) Underlying OS vulnerabilities.

a. Manufacturers should move away from using backend Operating Systems that are no longer supported such as Windows XP.

b. Promote regular security patch management.

c. Promote routine security audits.

5) Promoting redundancy.

a. Manufacturers can build a layer of redundancy in the device to ensure that if a given communication medium is disrupted, the device can continue to safely and effectively function.

It is difficult for medical device manufacturers to mimic a hospital network, so every measure should be taken to test the devices on test beds that are configured as closely as possible to a hospital network, or on the hospital network itself.

PMP: Does the concern about cybersecurity only apply to smart medical devices and drug-delivery devices used in hospitals, or would it also be a concern for smart devices that patients use at home (or on the go) that communicate with phone apps? 

Youssef: It’s a concern in both arenas. The challenges are similar from a device security perspective regardless of where it is being used.  When we introduce apps into the equation that adds another layer of complexity and a multitude of additional potential vulnerabilities.

If anything, in a hospital setting, there are usually security measures in place with traffic segmentation onto dedicated VLANs and robust firewalls.  The typical home network environment typically lacks this level of security.

PMP: What can potential attendees expect to learn from your session?

Youssef: This session is intended for medical device manufacturers as well as hospital staff. I will cover typical medical device cybersecurity concerns with a focus on:

1) How device manufacturers can help alleviate some of these, and

2) How healthcare workers can take proactive measures to identify cybersecurity issues.

PMP: What actions do you hope attendees will take after attending your session?

Youssef: My hope is that medical device manufacturers will make an effort towards establishing test beds that are more IT network focused. The other side of this is to ensure that health systems implement robust test processes and device onboarding processes to try and proactively isolate potential security issues.

Here are details on Youssef’s presentation as well as those from a few other speakers at MD&M West (Feb. 9-11; Anaheim, CA):

Wednesday, February 10

1:25 pm -1:50 pm 
Assessing Medical Device Cyber Risk in Your Connected Device

  • Recognizing various security threats to integrated medical devices
  • Listing controls relevant to a medical device IT security assessment
  • Exploring ways to manage risk when there is a cyber-security issue

Ali Youssef, Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM

1:50 pm – 2:30 pm
 Panel: Managing Risk to Keep Data Secure and Patients Safe

  • Overcoming the 3 main risk areas: patient safety, malicious activity, and data security
  • Factors to consider during product design with an eye toward cyber security
  • Recognizing cultural challenges such as availability vs. confidentiality of data and how to effectively deal with these in your organization

Moderator: Andrew Herger, Director of Engineering-IoT, DEDICATED COMPUTING

Michelle Longmire, MD, Founder, MEDABLE


Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM


Melissa Masters, RAC, Manager, Electrical, Software and Systems Engineering; Director, BATTELLE DEVICE SECURE SERVICES, BATTELLE 

 

Also, FDA had held a public workshop on cybersecurity on January 20-21, 2016, entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” It was held in collaboration with the National Health Information Sharing Analysis Center, the Department of Health and Human Services, and the Department of Homeland Security.

According to FDA’s draft guidance, “Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.”

Please click here for more details on attending MD&M West 2016.

 

Source Article from http://www.packagingdigest.com/patient-safety/pmp-consider-potential-cybersecurity-risks-when-developing-smart-devices-says-mdm-west-speaker-160129

Consider potential cybersecurity risks when developing smart devices, says MD&M West speaker

Have you considered cybersecurity risk? FDA has just released the new draft guidance, “Postmarket Management of Cybersecurity in Medical Devices.” 

“A growing number of medical devices are designed to be networked to facilitate patient care,” the agency writes in the draft. “Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats.” 

Should cybersecurity be considered during the development of smart drug-delivery devices? We asked Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, Henry Ford Health, this question and more. He intends to cover traditional medical devices as well as smart drug-delivery devices on Wednesday, February 10 at the upcoming MD&M West 2016 conference in Anaheim, CA.

PMP: Medical device cybersecurity has been identified as a potential concern by FDA. When it comes to developing smart drug-delivery devices (such as devices that may interact with a digital device for tracking dosing or other patient activities), what cybersecurity risks are there, and how can drug and device companies minimize those risks to protect patients?

Youssef: When it comes to developing medical devices, it’s critical for manufacturers to focus on the entire system, taking into account the network environment of a clinic or hospital as well as the clinical efficacy of the device. There are risks associated with the device itself, as well as how the device interacts with the network and the rest of the hospital or clinic ecosystem.  Some of the key areas that are of concern are: 

1) End-users leveraging default, or shared passwords on the device or the network that the device is relying on.

a. Device manufacturers can create workflows to ensure that the passwords in use are sophisticated and difficult to decipher using dictionary attacks.

b. Discourage the use of Pre-shared keys, WEP, or TKIP and rather promote AES encryption and authentication.

2) Patient Data compromised, or intercepted.

a. Ensure that data is encrypted in transit as well as while at rest or being stored on the device.

3) Medical device being susceptible to attack from within or outside the network.

a. Manufacturers can take measures to ensure that only secure protocols are used to access the device configuration.

b. Work with the hospitals and clinics to implement role-based access controls to ensure that a given device can only access what it requires on the hospital or clinic network.

c. Work with the hospital to ensure that a defense in depth strategy is in place to protect medical devices and the data they transmit.

4) Underlying OS vulnerabilities.

a. Manufacturers should move away from using backend Operating Systems that are no longer supported such as Windows XP.

b. Promote regular security patch management.

c. Promote routine security audits.

5) Promoting redundancy.

a. Manufacturers can build a layer of redundancy in the device to ensure that if a given communication medium is disrupted, the device can continue to safely and effectively function.

It is difficult for medical device manufacturers to mimic a hospital network, so every measure should be taken to test the devices on test beds that are configured as closely as possible to a hospital network, or on the hospital network itself.

PMP: Does the concern about cybersecurity only apply to smart medical devices and drug-delivery devices used in hospitals, or would it also be a concern for smart devices that patients use at home (or on the go) that communicate with phone apps? 

Youssef: It’s a concern in both arenas. The challenges are similar from a device security perspective regardless of where it is being used.  When we introduce apps into the equation that adds another layer of complexity and a multitude of additional potential vulnerabilities.

If anything, in a hospital setting, there are usually security measures in place with traffic segmentation onto dedicated VLANs and robust firewalls.  The typical home network environment typically lacks this level of security.

PMP: What can potential attendees expect to learn from your session?

Youssef: This session is intended for medical device manufacturers as well as hospital staff. I will cover typical medical device cybersecurity concerns with a focus on:

1) How device manufacturers can help alleviate some of these, and

2) How healthcare workers can take proactive measures to identify cybersecurity issues.

PMP: What actions do you hope attendees will take after attending your session?

Youssef: My hope is that medical device manufacturers will make an effort towards establishing test beds that are more IT network focused. The other side of this is to ensure that health systems implement robust test processes and device onboarding processes to try and proactively isolate potential security issues.

Here are details on Youssef’s presentation as well as those from a few other speakers at MD&M West (Feb. 9-11; Anaheim, CA):

Wednesday, February 10

1:25 pm -1:50 pm 
Assessing Medical Device Cyber Risk in Your Connected Device

  • Recognizing various security threats to integrated medical devices
  • Listing controls relevant to a medical device IT security assessment
  • Exploring ways to manage risk when there is a cyber-security issue

Ali Youssef, Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM

1:50 pm – 2:30 pm
 Panel: Managing Risk to Keep Data Secure and Patients Safe

  • Overcoming the 3 main risk areas: patient safety, malicious activity, and data security
  • Factors to consider during product design with an eye toward cyber security
  • Recognizing cultural challenges such as availability vs. confidentiality of data and how to effectively deal with these in your organization

Moderator: Andrew Herger, Director of Engineering-IoT, DEDICATED COMPUTING

Michelle Longmire, MD, Founder, MEDABLE


Ali Youssef, PMP CPHIMS CWNE, Senior Clinical Mobile Solutions Architect, HENRY FORD HEALTH SYSTEM


Melissa Masters, RAC, Manager, Electrical, Software and Systems Engineering; Director, BATTELLE DEVICE SECURE SERVICES, BATTELLE 

 

Also, FDA had held a public workshop on cybersecurity on January 20-21, 2016, entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.” It was held in collaboration with the National Health Information Sharing Analysis Center, the Department of Health and Human Services, and the Department of Homeland Security.

According to FDA’s draft guidance, “Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.”

Please click here for more details on attending MD&M West 2016.

 

Source Article from http://www.packagingdigest.com/patient-safety/pmp-consider-potential-cybersecurity-risks-when-developing-smart-devices-says-mdm-west-speaker-160129

Does this often-overlooked sustainable packaging metric deserve more attention?

When deciding the size of a product’s package—single serve versus multiserve or 12 versus 16 ounces, for example—brands typically consider consumer convenience, optimum shelf display or profitability. But perhaps sustainability should be higher up in that list. Here’s why.

“Larger product/packaging sizes are significantly more efficient than their smaller counterparts, regardless of material type.” This is one of five major findings in the 20th Anniversary Edition of “A Study of Packaging Efficiency, As It Relates to Waste Prevention” report from the editors of The ULS Report (ULS = use less stuff).

This conclusion is consistent with the two earlier groundbreaking studies done by ULS in 1995 and 2007. But the world has changed considerably, especially since the first study. It’s “greener” than it used to be. Not many packaging or marketing professionals talk about the product-to-package ratio, but it can be a critical measure of a product’s sustainability. And, intuitively, consumers often sense when the ratio is woefully out of whack, incorporating that into their purchase decision.

For foods or beverages, this ratio is just one aspect of a larger sustainability and packaging efficiency discussion. As the name of the report implies, waste prevention can be directly connected to sizing a package appropriately for the product’s use and the consumer’s lifestyle. Too big and the food might spoil before it can be completely eaten. Too small and you could be generating more packaging waste than your customers will accept.

How does package size compute when taking into consideration product waste? Robert Lilienfeld, ULS editor and Packaging Digest contributing writer, says, “The odds are good that larger sizes would generate more waste, if purchased by price per ounce rather than the number of portions needed.”

What if the number of portions needed is one, though? Aren’t single-serve packs inefficient from an overall sustainability perspective (energy used to produce, for example), not just looking at the product-to-package ratio? That’s what makes this a rather complex issue, despite the simplicity implied by the numbers. Portion control can aid consumers’ health/weight goals, provide hygienic assurance and enable on-the-go consumption or use—conveniences that often out-weigh sustainability objectives. “These consumer factors can be at least as important from an overall sustainability standpoint, compared to only looking at packaging-related information,” says Lilienfeld.

Let’s take a look inside some actual numbers.

This latest ULS report measured the product-to-package ratio and net discards in pounds for seven different foods. The numbers reported assume at-home use and disposal. What about away-from-home situations, which could represent a significant effect because of today’s on-the-go society? How might that skew the ratios and discard numbers? “The logical effect is that efficiency goes down for out of home, as the recycling rate would decline,” Lilienfeld explains.

The examples in the table below highlight how much more efficient large sizes can be than their smaller counterparts.

In most instances, the larger the package, the higher the product-to-package ratio. In two cases—for milk in high-density polyethylene bottles and soup in aseptic cartons—the ratio stays the same regardless of the package size. “Both sizes are large enough that efficiency is about equal,” Lilienfeld explains. “This is also due to rounding. For soup in aseptic cartons, the larger rounds down to 96% and the smaller rounds up.”

The multipack effect, shown in the cereal category, shows how this portion-control and on-the-go convenience takes a major sustainability hit.

And while larger sizes are more efficient despite the type of packaging material, material choice does influence the amount of net discards. Glass, not surprisingly, ranks highest by weight. Flexible packaging, as expected, often logs on the lowest end of the spectrum of discard weight.

Lilienfeld also points out how some product innovations, like the Tide Pods, create a product/package system that makes a sustainable comparison to the previous or competitive packages difficult. The newer product, detergent/stain remover/brightener-in-one, replaces two separate products (detergent and bleach), each in its own package. Additionally, the newer products are highly concentrated, saving more space and needing less packaging material to contain.

This type of product/package innovation—while a win-win in consumer convenience and sustainability—is the outlier. The report deduces that “Ultimately, packaging decisions are driven by consumer perceptions and lifestyle requirements. In many cases, these factors lead to more packaging rather than less.”

Two reasons support this conclusion (as cited in the report):

• “We tend to equate quality with quantity. A 500mL bottle of store brand water weighs 8.8 grams and has a retail price of $0.13. A 500mL bottle of a typical ‘performance brand’ weighs 27.3 grams and retails for $1.19. While the latter’s heavier weight and higher prices may increase quality perceptions among users, they generate greater environmental and economic costs for society.”

• “We strive to achieve active, healthy lifestyles. This state of mind leads to the demand for packaging to deliver convenience, ease of use and portion control. Resulting packaging responses generally lead to inefficiencies, as they require smaller sizes or the increase functionality needed to deliver ready-to-eat, ready-to-serve and out-of-home product solutions.”

This is just a mere sample of the compelling data in the full 60-page report, published January 2016, which you can download for free. It includes expert analysis on five major findings, as well as raw data for 300+ products in more than 50 different product categories.

This is the level of detail I’ve come to expect, trust and appreciate from studies done by the leading consumer testing and rating magazine Consumer Reports.

 

______________________________________________________________

Learn about the latest developments in sustainable packaging at WestPack 2016, Feb. 9-11 in Anaheim, CA.

______________________________________________________________

Source Article from http://www.packagingdigest.com/sustainable-packaging/does-this-often-overlooked-sustainable-packaging-metric-deserve-more-attention-2016-01-29

5 ways to prevent packaging waste

Source reduction, recycling and “efficient” packaging continue to be go-to methods to minimize the amount of waste sent to landfills in the U.S.

The just-released 20th Anniversary Edition of “A Study of Packaging Efficiency, As It Relates to Waste Prevention” report, produced from the editors of The ULS Report (ULS = use less stuff), identifies key characteristics of product/package systems that add to their overall level of efficiency and sustainability. The data in this report can be used to ensure that cradle-to-grave analyses that compare packaging alternatives consider all relevant information.

Five major findings in the report are:

1. “The best way to reduce materials going to landfills (net discards) continues to be through the use of lighter weight packaging.”

2. “Recycling of primary packaging (defined as recovered material) plays a prominent and growing role in reducing discards.”

3. “Source reduction continues to play a significant role in the effort to reduce material usage and waste, even given the large amount of light weighting that occurred in the 1970s.”

4. “Larger product/packaging sizes are significantly more efficient than their smaller counterparts, regardless of material type.” (Packaging Digest took a deeper dive into this finding in “Does this often-overlooked sustainable packaging metric deserve more attention?”)

5. “Product packaging is more efficient for products that require more preparation by consumers” (such as concentrated products and mixes) versus ready-to-serve/use options.

Read conclusions drawn from the results by downloading this free 60-page report, published January 2016. It includes expert analysis, as well as raw data for 300+ products in more than 50 different product categories, from foods and beverages to personal care products and household goods.

 

___________________________________________________________________________

Learn about the latest developments in sustainable packaging at WestPack 2016, Feb. 9-11 in Anaheim, CA.

___________________________________________________________________________

Source Article from http://www.packagingdigest.com/sustainable-packaging/5-ways-to-prevent-packaging-waste-2016-01-29

Can you scale up production and please patients?

Developing a combination product from concept to market can take years, observes Bill Welch, chief technology officer and vice president of engineering for Phillips-Medisize Corp. So how can a company increase its chances for success? Come up with a design that is both desirable to patients and manufacturable, says Welch.

Welch will be exploring strategies that balance both aspects in “Integrated development and scale-up of combination products” at Pharmapack Europe on February 10 in Paris. He will share a case study examining what makes a device successful in terms of manufacturing and assembly as well as patient acceptance. 

“Everything comes down to getting a better therapy in the hands of a patient,” says Welch. “A good device can help users adhere as well as avoid mistakes through simplicity and intuitiveness.” 

However, you can have a great device, but it could still fail, he warns. Desirability must be balanced with manufacturability, which entails developing a design that allows production scale up.

Welch advises “minimizing part variation” and following Quality by Design principles. “Driving out variability allows you to scale,” Welch tells PMP News. Doing so allows “individual components and the assembly process to be easily replicated and scaled so that high volume is possible.”

While manufacturability is important for any product, there are complexities to combination products that bring unique challenges. For inhalation devices, for instance, there’s “a high degree of interaction between the drug formulation and the device itself that impacts the aerosolization of that drug,” Welch points out. Device design decisions therefore need to be made early during product development before the product goes through clinical trials. “It’s different for a typical injectable drug, which could go through a clinical trial with a typical vial and syringe,” he says. 

And because the device must be considered so early, so must design for manufacturing and assembly, he adds, stating that his case study will highlight such challenges.

Welch says that there are “tried and true methods for assembly and injection molding” that can promote manufacturability, for instance. But when asked whether they involve stock components, he says “its very tough to make stock components” for combination products.

It’s more about the “integration of disciplines, such as human factors and electrical engineering,” for instance, he says. “All have to be on the same page for manufacturing. I’ve seen a lot of innovation in inhalation devices—the use of electronics and electromechanics are critical to the function of the device.” 

Also, “it takes a lot of upfront cooperation,” he adds.

A desirable, manufacturable device could be welcomed by the market. “Inhalation devices have the greatest potential for misuse,” he says. “Next-generation devices can sense breathing and can time drug delivery with it, even if shallow or faint. You can reach a group of patients who didn’t have such a device before, such as young children, unconscious patients, or the very ill.” 

In addition to speaking, Welch will be on hand at Phillips-Medisize’s Booth #616 at Pharmapack Europe February 10-11

Phillips-Medisize will also be exhibiting at MD&M West in Anaheim February 9-10 in Booth #3011.

Welch spoke about designing smarter and smaller drug-delivery devices before at Pharmapack North America in June 2015.

Source Article from http://www.packagingdigest.com/packaging-design/pmp-can-you-scale-up-production-and-please-patients-160128

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Change is coming to pharma packaging, predicts Pharmapack Europe speaker. Are you ready?

Healthcare systems around the world are under severe pressure to improve patient outcomes while reducing costs. Over the years we’ve shared many insights from packaging experts suggesting that patient-centric packaging (in one format or another) that enables patients to care for themselves as directed could reduce overall healthcare spending.

It’s difficult to disagree, but changing to such patient-centric packaging has been a gradual, almost linear evolution, so the gains may not be keeping up enough to relieve the pressure. Such change typically comes about only after a specific push, such as the design opportunity a new drug or medical device brings, a specific customer or payer request, or regulation. 

But there may be another source of change, and it may not be as gradual. Peter Schmitt, managing director of Montesino Associates, urges the industry to prepare for external drivers of change. He speaks about the growing tension between changes sought by Millennials and the status quo defended by Boomers (incumbents), and he also points out that significant societal changes brought about by disrupters Apple, Google, Amazon, and others may also change healthcare, and therefore change packaging. 

Schmitt will be speaking at Pharmapack Europe February 10 in the presentation, “Boomers, millennials, and the future of packaging materials.”

“Boomers are frustrated about change,” he observes. “But millennials are frustrated that things are changing so slowly.”

First speaking about this phenomenon at Pharmapack North America 2015, Schmitt calls it the “Molecule Centric/Blockbusters versus Patient-Centric/User Interface.” (Read our article on disruption here.)

“Since the 1980s, pharmaceutical packaging supported a molecule-centric business model, one that looked to develop, launch, and maintain new blockbuster molecules in a globally harmonized marketplace,” he says. “As such, the focus of packaging was to remain ‘off of the critical path’ and, rather than focus on ease of use, or new developments that saw packaging supporting compliance or adherence, the primary focus of packaging was accelerating and supporting molecule approvals.” 

But we’re in a different world now, not only because healthcare systems are seeking improved quality in care, but also because patients are, too. Today’s patients are also today’s consumers who are now used to just-in-time, user-centered product innovations that make life easier and more convenient. These patient/consumers are also used to living a connected existence, where information is available at their fingertips.

Pharmaceutical and medical device packaging will need to serve these patient/consumers differently than it has ever done before.

When it comes to packaging materials, Schmitt wonders whether the traditional emphasis on approvals and regulatory concerns may change. “For over 25 years, pharmaceutical packaging materials focused on supporting stability testing and regulatory approval. There are voices today calling for that focus to shift. Will the voices be heard?”

Packaging design, too, may need to focus primarily on the patient and promote safety, compliance, and ease of use. “In the world of Apple, Google, Elon Musk, and others, design and innovation are now critical tools in gaining competitive advantage. Will those voices impact pharmaceutical packaging?” Schmitt asks.

Schmitt will also explore future trends to watch, such as potential shifts to outsourcing to support the search for innovation, the ongoing dilemmas for solid oral doses of rigid versus flexible and bottles versus blisters, and the emerging roles that intelligent packaging could play. “The drive for packaging to communicate with patient and healthcare professional is growing rapidly. Whether driven by regulatory agencies (serialization and traceability) or consumer groups, voices are demanding intelligence and communication in packaging. Will the Internet of Things include pharmaceutical packages?” he asks.

When approaching these issues, Schmitt urges packaging designers to think a little differently. He points to a January 2016 blog by Tor Bair, “Your Life Is Tetris. Stop Playing It Like Chess,” musing that “Pharmaceutical packaging is Tetris. Stop playing it like chess.” 

Schmitt applies Bair’s observations to pharmaceutical packaging: “[Bair observes that] chess wires us to think causally. It consists of singular movements; there is a winner and a loser, an ‘other’ (innovator vs. generic, for example), etc.,” says Schmitt. “[As Bair states,] in the game of Tetris, things don’t get harder; they just get faster. As we look at pharmaceutical packaging, Tetris with its many inputs and ever faster changing play offers a strong analogy for the future of pharmaceutical packaging.” 

Schmitt points to “a number of factors accelerating in a direction and randomness continuing to play on a roll, more like Tetris than the famous chessboard.” He points to these factors and asks the following questions:

  • Amazon versus Walmart: what is the future of pharmacies in the distribution of medicine in the United States and globally? 
  • Apple, Google, Facebook: the coming of new players. They want in. Will they succeed? 
  • Smart packaging and regulatory authorities: how will information traditionally conveyed by printing changes and how disruptive will new regulations be to pharmaceutical packaging? 
  • How will packaging interface with smart phones and the Internet of Things? 
  • The User Interface: how will the package itself change, both as a more important part of drug-delivery systems (combination products), and as a way to make it easier for the patient to take drugs?

“If our market moves like the Tetris game flow rather than chess, we may indeed see change and have to (finally) cope with a speed of change that’s new to the industry,” he says.

Attend Pharmapack Europe to hear Schmitt’s presentation along with several other thought-provoking sessions. Schmitt will also be joining me as I moderate a roundtable on packaging innovation.

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