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Articles from 2017 In January


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3 steps for designing the ideal medical device packaging system

3 steps for designing the ideal medical device packaging system
Image source: CleanCut Technologies LLC

Medical device packaging design is an integral part of delivering your device to market safely and securely, with the sterile barrier intact. Yet this critical process is often given little attention in the overall product development process. Most single-use sterile medical devices can be opened with a high degree of confidence that the product has maintained sterility throughout the product lifecycle, yet getting to this point can prove troublesome. Here are three steps to consider when designing your ideal medical device packaging system.

1. Start packaging design early in the product development process.

Thoroughly defining the requirements of a packaging system early in the product development process sets the stage for long-term success. Prequalifying those requirements prior to full package system validation will save time and money in the long-run. Preliminary evaluation of product-package compatibility allows for early detection of design or manufacturing problems and affords time for revisions prior to full validation. Identifying possible packaging system failures and addressing them proactively during early design phases greatly increases the chance of successful validation and patient safety. When this step is skipped or left to the final hour, short-cuts often utilized to save time and money can increase the risk of noncompliance with regulations. Instead, during this process different sterile barrier systems can be evaluated and manufacturing methods evaluated to best meet the needs and characteristics of a particular device.

Test failures are not an uncommon occurrence and must be taken into account during the development process. Failure to plan is planning to fail. By starting this process early in product development, these contingencies can be addressed early, and unwelcomed delays and added costs can be avoided.

2. Properly size packaging components.

Loss of sterile integrity, one of the most common types of packaging failure, is often the result of improperly sized packaging elements in relation to the device. These packaging elements include the backer card or tray to retain the device, the pouch or lid, the shelf carton, and finally the corrugated master shipping container. If any one of these elements is improperly designed or sized in relation to the other, unnecessary movement will likely create complications during transportation and result in failure of your sterile barrier system.

For example, if the backer card is too large, constant pressure will be placed on the pouch seals. If it is too small, excessive motion within the pouch will create friction and abrasive forces. A pouch or tray lid within a shelf box that is too large will need to be folded or creased; one that is too small will be subject to repeated contact against the inner box, all of which cause stress and fatigue leading to pinholes and pouch failure.

Individual shelf cartons need to fit snugly around their contents to prevent movement during transportation, while the master shipping container must maintain sufficient rigidity and wall strength to protect the inner cartons consistent with the distribution environment of the device. All of these elements must be customized to the device, and they must work in tandem to reduce the risk of failure and successfully deliver your device to market.

 

3. Utilize a robust testing protocol.

Packaging concerns should be addressed from the very first step of the project to quickly identify unforeseen contingencies in design. Short-cuts simply cannot be taken during this critical testing process. ISO 11607: Packaging for Terminally Sterilized Medical Devices, published in 2006, is the principal reference guide for medical device packaging and includes information on testing requirements. ASTM and ISTA Series distribution testing offer a set of specific test methods for compliance with ISO 11607.

For guidance related to a specific medical device packaging system, collaboration between a project team and an ISO 17025 accredited laboratory is necessary to ensure the proper test methods are utilized. Establishing a protocol prior to testing complete with clearly understood pass/fail criteria is paramount to identify problem areas in packaging design. A robust protocol would include scope, responsibilities, appropriate sample size, production equipment, parameters, and acceptance criteria, to name a few.

Your Ideal Packaging System

In the competitive landscape of the current medical device marketplace, almost as important as the medical device is the package it arrives in. Packaging today has evolved from an afterthought to an integral part of the device user’s experience. In many cases, the packaging system is designed to be as unique as the device itself. Much needs to be considered in the process. The packaging system must maintain the sterile barrier system, protect the device while in transit and use, and successfully communicate the device maker’s branding and value proposition. When this process is considered early with great intent and purpose, mistakes can be avoided, costs can be saved, and the ideal packaging system can be created.

Brian Whalen (above) is director of sales & marketing for CleanCut Technologies LLC (www.cleancuttek.com). The company will be exhibiting at Booth #1361 at MD&M West in Anaheim, CA, February 7-9, 2017.

All images in this article are provided by CleanCut Technologies.

Why you should care about human factors

Why you should care about human factors
Craig Scott, director of Greensand

There’s no question that interest in human factors is increasing. But are pharmaceutical and medical device designers actually putting such principles to use? PMP News asked Pharmapack Europe speaker Craig Scott, director of Greensand, a few questions about human factors as they apply to drug-delivery devices and packaging. On February 2, Scott and Martin Schlaeppi, also director for Greensand, will present "Why Better Human Understanding Is the Only Future."

Scott tells us that Greensand works across the medical device spectrum from early innovation and concept assessment with users through to pre- and post-launch and has a particular expertise in understanding the functional and emotional needs of medical device users.   

PMP News: Why should pharmaceutical and medical device manufacturers consider human factors?

Scott: Firstly, because it’s a regulatory requirement for some classes of medical device. However, it’s such a great opportunity to engage with users—be they physicians, nurses, or patients. The primary focus of human factors research is risk reduction by ensuring users can interact with medical devices safely and effectively. This, clearly, is no bad thing, but why wouldn’t you take the opportunity, whilst you have these users available to you, to talk to them more holistically? You will undoubtedly learn about how they interact with a device functionally but people engage with their lives, their health conditions, and other people emotionally. By understanding and acting on this knowledge, offering both functional and emotional benefits, you put yourself in a position to better connect with users and achieve greater desirability and, therefore, competitive advantage.

PMP News: Are companies increasing their use of human factors studies? Is there still a need for educating companies on the need to do so?

Scott: Yes, they are, as the regulatory need is understood and met. You can see more companies setting up to meet the increased need. There is still a lot of education about human factors that is needed, but Greensand also thinks that there is a need for educating the medical device industry about best practices from other industries. There’s fantastic learnings to be had from, say, the consumer industry, who have long been masters at understanding their customers. There’s absolutely no reason why the medical device industry can’t adopt and benefit from the powerful techniques and approaches that are commonplace elsewhere. There seems to be a lot of talk about being ‘patient-centric’ but we don’t think people necessarily know how to go about this.

PMP News: Could human factors studies help companies design products that minimize human errors?

Scott: Undoubtedly. That’s the prime reason for doing them. We’ve personally seen patients and nurses pick up autoinjectors the wrong way and attempt an injection. We’ve also seen patients and nurses misunderstand how to use a device because they’ve not read the instructions for use (IFU) or the IFU is not clear enough about the steps to follow. It should be appreciated that human factors studies do aim to minimize human errors, but they can’t remove the risk of error entirely as user error is out of your control, and it is amazing how creatively wrong users can be—in ways you could not dream of. But, that is the curse of knowledge—you can’t unknow what you know. What is so obvious to you could be completely lost on a user interacting with a device for the first time. That’s why engaging with device users at every stage of device development is critical—from the very earliest stages of ideation through early- and late-stage prototyping to the final summative test of a production-ready device.

PMP News: Are there any common errors that could be addressed?

Scott: It depends on the device. Given that medical devices cover such a vast spectrum with each one addressing very different needs, the type of error that is common tends to be common only to that type of device. Holding an autoinjector the wrong way being a classic—for autoinjectors. What should be common is, where possible, to get users to simulate or use the device in as realistic a way as possible. That may mean, for example, re-creating the environment a device is used in. A classic error for a monitoring device being used in an ER setting is that the alarm is too quiet to be heard. You can hear it perfectly in the peace of a test lab but not in a noisy emergency situation. There is a component within the human factors process that addresses known use-related problems via a number of databases and also via heuristic analysis whereby a device’s user interface is evaluated against user interface design principles, rules or “heuristic” guidelines.

PMP News: What types of products should be developed with human factors in mind?

Scott: Primarily any product that could pose a risk to a user from incorrect use; this inevitably covers many types of devices but not all. The principles of human factors and usability engineering are still valid even in less risk-prone devices, because anything that people interact with that is easier to use, well designed, comfortable to use, and so on will tend to be preferred over less-well-designed offerings. The risk of not engaging with users is that you develop something nobody cares about.

PMP News: Should products used by both professionals and patients be subjected to human factors studies?

Scott: Yes, absolutely. The critical consideration is the “user.” This may be wider than it seems at first. It may be obvious that a physician, nurse, or patient might be a user, but what about technicians, pharmacists, physiotherapists, occupational health, social workers, caregivers, teachers, and so on? Part of the initial definition process for human factors research is to consider and evaluate all potential users of a medical device.

PMP News: How will human factors change drug-delivery devices?  Packaging design? The future of healthcare?

Scott: For those who assess devices as we think it should be done (understanding the user holistically) then drug-delivery devices should evolve to become better and more desirable, offering relevant solutions to user’s needs. What is often overlooked is that drug-delivery devices exist in a competitive set. Some being better than others. The best is the one that will be selected or recommended most often, being more desirable to the user. A good example is a GPS-enabled inhaler (similar to the ‘find my iPhone’ function). Not only is it a practical system for assessing areas where the device is used frequently—perhaps highlighting areas of high allergenicity (a clinical benefit) —but it could also help the user locate a lost inhaler (a functional benefit). Also, importantly, this system can address the well-known heightened anxiety asthmatics feel when they cannot locate their medication (providing an emotional benefit). Needless to say, cost is a perennial factor, but mass production always quickly reduces cost, and a highly-valued function will be traded-off against price in many instances.

The same goes for packaging design—changes that address users’ needs can offer real functional benefits that will deliver competitive advantage for the manufacturer. Beyond purely functional benefit, packaging also has a role in developing the “brand,” and it is that which users engage with at an emotional level and results in “desirability” —not a tangible asset but an asset nonetheless.

For the future of healthcare, bringing users into the mix to evaluate how they interact with devices can only be a good thing. It remains, however, a huge missed opportunity if all you’re doing is satisfying legislation and not taking the chance to learn as much about users whilst you’re there. We foresee a day where human factors is the final sign-off of a developmental journey that has had user input and feedback from beginning to end.

PMP News: What will pharmaceutical and medical learn during your presentation at Pharmapack?

Scott: That better human understanding is the only way forward. That human factors, ironically, lacks humanity. That an industry founded on data and rational thought only can lead you to think too much and feel too little. That we can learn from others and apply that learning to compete harder, to raise our game and to benefit users everywhere. That, for drug delivery, your device could be the point of competitive advantage—not the medication. That he who understand his users the best, and actions that understanding, wins. 

PMP News: What do you hope they do differently after attending your presentation?

Scott: That they understand, from the real examples we’ll share, how appreciating users’ holistic needs, both functional and emotional, could give them an advantage in the competitive market place. That this knowledge, combined with raised awareness and interest, is enough to be willing to try methods and techniques that may be new to them but are very common in other industry sectors.

For more details, visit www.greensandconsulting.com or contact Scott at [email protected] and + 44 (0)1483-461809.

A sticky but helpful situation for fragile medical devices

A sticky but helpful situation for fragile medical devices
Components being loaded on Gel-Pak via pick & place equipment

One stop on our Packaging Innovation Tour at MD&M Minneapolis 2016 was Gel-Pak, a company offering a biocompatible gel that can be coated onto the bottom of boxes, trays, slides, and films to secure medical components in place during transport, processing, and storage. 

The “gel” is a proprietary highly crosslinked elastomer that has strong cohesive strength, so it does not generate particles unless damaged by the user (with sharp tweezers, etc.), reports Jennifer Dossee Nunes, Director of Marketing. “When devices are placed on the gel, they are held securely in place until they are removed using tweezers or automated pick and place equipment,” she says.

When asked about weight limits and applicable materials of the products that can be held, Nunes says that “there is no simple answer. Our Gel works with most materials, and the weight limit is a function of the type of Gel-Pak carrier used, the Gel retention level, and the how it is used.  Once we understand the customer’s application, we provide the best samples for them to evaluate.”

And when asked whether the gel could be placed in a thermoformed tray to hold a medical device, Nunes says it is possible. “The easiest way is to laminate a sheet of WF-A film into the carrier,” she says. 

She also believes that the gel could be sterilized as part of a package that undergoes terminal sterilization, but she advises that samples should be tested and validated.

Gel-Pak makes two grades of gel material; a standard grade and a highly purified version (Process B) recommended for highly sensitive devices. The Vacuum Release (VR) product line is built using Process B Gel, and Process B is also available as a special option for the Gel-Box, Gel-Tray, Gel-Slide, and Gel-Film products.

Gel-Pak’s products have been used to hold items such as medical coils, platinum marker bands, medical staples, medical electronics, etc., she says. 

Above: Gel-Pak holding medical staples

For more details, visit http://www.gelpak.com/--gel-technology.

Gel-Pak's parent company Delphon will be exhibiting at Booth #1528 at the upcoming MD&M West in Anaheim February 7-9.

Click here for a list of the Innovation Tours at the show.

Model VFFS Packmaster Poucher/Bagger

Vertical Form Fill Seal Bagging System

Model TBS 3/8

Tabletop Band Sealer

Model ATS

Air-operated Table Sealer

Model SBP with Model DS

Speedy Bag Packager with Drop Sealer

Model HCBS 1/8TX

Model HCBS 1/8TX

Horizontal Conveyorized Band Sealer with Trim

6 packaging solutions seen at EastPack

6 packaging solutions seen at EastPack
Liquid nitrogen dosing, using systems from Vacuum Barrier Corp., helps extend shelf life of foods in stand-up pouches.

EastPack 2014 enjoyed a successful run this week at the Javits Convention Center in New York City. It closes today at 3:00 p.m. eastern time.

Here are a few new packaging solutions seen on the show floor:

Liquid nitrogen dosing for stand-up pouches

The easy-to-teach Baxter robot

Versatile pouch sealer

Thermal labels from a familiar company

Integrated bar code printing

Clear cartons for product sampling