Originally Published MDDI June 2005
Product Development Insight
Developing Drug-Delivery Devices: Early Involvement Is Key
Devices that deliver innovative drugs well can lift a product to blockbuster status. Success, however, requires early involvement of device manufacturers in the drug-development process.
John Taenzler and Richard Vanderveer
|John Taenzler and Richard Vanderveer|
As with all medical devices, the success of a drug-delivery device—such as a syringe, patch, or osmotic capsule—relies much on its design. However, a drug-delivery device is only one component of the medication product as a whole. Where some devices succeed and fail on their own merits, a drug-delivery device is more of a tool that enhances, or possibly ruins, the image of the medication it is associated with.
Despite the important role they play, the device components of such systems are too often an afterthought in the development process. Instead, the device component should be developed concurrently with the medication as an integral part of the process. In many cases, innovative devices are developed in response to market research that suggests that the only competitive advantage of the device is its ability to deliver drugs. Although cloning a market leader and making it easier to use may hold some promise in terms of profitability, a true market advance comes from an innovative device that delivers innovative medication.
Take, for example, one of the most recent advances in asthma treatment. The antiinflammatory and broncho-dilator components of the medication had each been available for years. The product's innovation was putting the components together to treat both the bronchoconstrictive nature and inflammation of asthma. This combination product could have been packaged in a traditional metered-dose inhaler, but the company decided instead to package it in an easy-to-use dry-powder inhaler device.
This product is an example of the whole being greater than the sum of its parts. Two good drugs plus one simple device equaled a blockbuster.
Conversely, plenty of products are no longer on the market or are relegated to last-resort status because they hit snags at the engineering phase. Often, these devices are technological marvels, but they involve an exhaustive number of steps to prepare and are complicated to administer. So even though the devices that are used to deliver the drugs are not the primary reason prescribers select a medication, the devices are vital to the ultimate success of the medication.
When device manufacturers work with pharmaceutical manufacturers, it quickly becomes obvious that the pharmaceutical company's focus is primarily on the drug portion of the product. Considering that development costs for a new pharmaceutical are approaching half a billion dollars, that makes sense. Unfortunately, this intense focus sometimes makes it difficult for pharmaceutical companies to see the significance the device component can have in the overall success or failure of the product. Drug-delivery devices do more than just ensure the accurate administration of a medication. They are part of the brand's personality, and as such, are key to its success.
It is vital that manufacturers of the device component convey this point to pharmaceutical companies developing the drug counterpart that will be administered. In addition, device manufacturers that partner with market research firms are often able to access drug-development information more easily and quickly. This article provides information device manufacturers can use when developing a drug-delivery device in conjunction with a pharmaceutical company. This information should help device companies convey the importance of involving the device design team early and often throughout the drug-development process.
Designing the Optimal Drug-Delivery Device
To develop a drug-delivery device that optimizes use of the product's medication, manufacturers must coordinate design engineers and marketing research. Design engineers require information about market dynamics, including market needs (i.e., what is lacking in currently available devices) and end-user capabilities. The latter goes beyond the ergonomics involved in manipulating and actuating the device. Determining end-user capabilities also involves factors that include the following considerations:
• What physical difficulties will end-users have? For example, it is prudent to think about children with small hands, arthritic patients with hand deformities, and elderly patients with diminished hand strength.
• What capacity does the end-user have to understand operating instructions? Consider users' level of literacy, ability to follow a series of steps, and ability to problem-solve if the device malfunctions.
For devices that deliver medication, good device design must be intuitive for the end-user. A device to be used by a medical professional requires a different level of expertise than one to be used by a child or an elderly person. An engineer cannot fully anticipate issues faced by end-users without first gathering information from these users.
One company recently tested a prefilled injection device to be used by patients with greatly diminished hand strength. The device came with an attachable sleeve designed to fit around a patient's hands so that the patient wouldn't have to grip the device in a closed fist to hold it. Both physicians and nurses felt that the sleeve was a good idea and that it would be well received by patients. But when presented to patients, the sleeve was uniformly rejected. They felt that the sleeve prevented them from employing alternative and more-comfortable grips and interfered with their ability to activate the device. They also said it was psychologically unappealing. Many thought the sleeve made them look sicklier than they felt.
Common Design Pitfalls
Although it is important for the drug-delivery device to differentiate a pharmaceutical product from its competitors, the design team must also carefully consider the context in which the device will be used. Design teams must be aware of the following scenarios so they can then help steer drug manufactures clear of these pitfalls:
• The device is completely unfamiliar. For every revolutionary design that succeeds, many fail. Novel ways to administer medications require special training and long trial periods before gaining widespread acceptance. Drug manufacturers must be aware that it can be difficult for users to switch from familiar devices to new designs.
• The device is either too complicated or too easy to use. Most drug-delivery devices must be simple enough for users to learn, yet complex enough to provide feedback that a device is used correctly. These devices must have a dose-counter or another way of showing that the medication has been administered.
Conversely, some devices require multiple steps that can easily be forgotten or omitted. This is particularly important if the patients are to use the device themselves. If an omission could prevent accurate medication delivery, the device will be rejected. Manufacturers should ensure that their pharmaceutical partners are aware that devices that are familiar or otherwise intuitive require little training. Such devices may enhance the adoption of a new drug. Conversely, devices that are novel or require extensive training will experience a longer trial period before maximum market share can be realized.
• The R&D team is married to a design and is inflexible to change. Just because a device design is appealing does not mean that it will work. Multiple designs should be tested with the pharmaceutical early in the design process. In addition, each subsequent stage in the device's development should be tested and adjusted as needed.
• Delivery of the medication is unnecessarily invasive. Both device and drug manufacturers should remember that patient and physician preference is key to a drug-delivery device's acceptance. To them, devices that can deliver drugs orally are better than those that require inhalation. Devices that deliver drugs by inhalation are better than those that deliver drugs subcutaneously, and subcutaneous delivery is better than intramuscular delivery, which is in turn better than intravenous delivery. A device that offers an injectable medication delivery when an inhaled form is available may doom the product to failure.
Designing the Device Component
It is never too early for the device design team to get involved in the product development process. In fact, the device should be tested simultaneously with the drug-development process.
A thoughtful design will incorporate as much external information as possible. Determining market needs and assessing where other products have succeeded or failed can guide early development of drug-delivery devices. That way, once resources have been committed, the chances for product success are greatly increased.
Unfortunately, the point at which device companies are asked to participate in the drug-development process is the factor over which they typically have the least control. However, device companies can gain better access to early drug development through strategic partnerships with marketing research firms. Most, if not all, pharmaceutical companies incorporate customized marketing research firms early in the drug-development phase. When a new chemical is developed, research is conducted to determine whether it has a viable market. This type of research typically continues throughout the clinical development phases of the drug. Therefore, marketing research firms have unique access into early drug development and can communicate to pharmaceutical manufacturers when device research should be initiated. Developing strategic partnerships with these organizations can enable device manufacturers to step into the process earlier than otherwise expected.
Making the Team
For drug-delivery devices, team members should be involved in all aspects of the device's development. Each part of the team will most likely contain more than one individual and must include the following departments:
• R&D. Members may include individuals in-house but often also include consultants specializing in the design or manufacture of medical devices. These team members, including engineers, draftsmen, and industrial-organizational psychologists, bring the engineering knowledge to the group. They direct the design and refinement of the device. They typically also conduct any ergonomic analyses.
• Product management. Members guide the strategic direction of the medication brand, including the device.
• Marketing. Members provide insight into what marketing messages and claims can be developed around the medication, which can in turn be reflected by the device.
• Marketing research. Members act as the conduit for communication between members of the team and target users. The team ensures the successful execution of research initiatives.
Putting the Plan into Action
The development and marketing of a drug-delivery device should be an evolving process, not an afterthought. It may fall to device manufacturers to convey this point to drug manufacturers. Innovation comes through careful planning and testing, which can only be accomplished by involving the device design team early. Drug manufacturers must understand that if they wait to involve the design team, and therefore try to fit a drug into a pre-existing device design, the end product will lack originality and will have fewer competitive advantages.
Each step of the drug-development process is associated with specific research initiatives (see Figure 1). Device manufacturers should become familiar with each of these steps, since these initiatives will provide valuable feedback to the device design process. In addition, these initiatives will aid in the final FDA approval process by providing required data about the device and the steps taken by manufacturers to validate claims about the device. Awareness of the value of each step is critical. If the design team is familiar with the steps, it can help the team create a research plan with its drug company partner or counterpart.
Investigating. Once it has been determined that a delivery device is required, research should be conducted to answer the following questions:
• What is currently available?
• What are the strengths and weaknesses (from a physician's, educator's, and end-user's perspective)?
• What are the unmet needs?
• How can a device fulfill these needs?
Conducting a thorough qualitative market assessment can determine the market landscape for particular types of drug-delivery methods. These data can guide the development process. The information shows R&D what does and does not work with the product, what issues are surrounding current products on the market, and what new features would be considered significant advantages.
Once designs are developed, further research can determine the optimal configuration of device features. As with most device design, specific trade-offs in the design may be necessary. Quantitative feature analysis research can guide and triage which features are most important and where the bulk of the development efforts should be made. Data gathered from this research can be used to refine designs and develop prototypes to be tested with the medication.
At the investigation stage, device manufacturers should begin to wonder how the device component will increase the use of the end product. Unlike drug product features such as side effects, indicated use, dosing frequency, etc., market research assumes that a device itself may not directly drive the use of a medication. However, it is assumed that it will modify the medication's use. As such, the effect of a device can be measured as a separate exercise in a market research study.
It is important to measure reactions to the medication and gather estimates of trial usage and final market share for it. Then respondents can be shown devices (or their component parts) and asked how these might modify the respondents' adoption estimates. This exercise may include a device feature analysis to determine how specific features affect the use of a medication. It may also involve presenting different prototype devices to determine how specific device designs will affect the medication's use.
All of these data help focus both the drug maker and the device manufacturer on the elements most compelling to prescribers and those that will promote use among end-users.
Refining. Once prototypes have been developed, they must be put into the hands of prescribers, educators, and users. Hands-on research can answer specific questions:
• Is the device easy to hold? How will users hold it?
• Is it easy to set and activate? Is it intuitive?
• Can patients with disabilities (i.e., visual, auditory, kinesthetic, motor skills, etc.) easily manipulate and use it? Are there variations in use or manipulation?
• Is it too big or too small? Is it too light or too heavy?
A qualitative usability study can provide insight into the practical use and application for a device. Data from such a study can identify problems with using a device as well as potential solutions to those problems. A usability study can also give the product team insight into the mind-set of the user, which will be important in the later stages of marketing.
Positioning. The design team can use positioning research as the basis for making subtle refinements to the device to further differentiate it from the competition. These refinements may be as obvious as streamlining the overall shape and appearance of the device to establishing a color scheme that best reflects the brand.
A drug-delivery device reminds users of the drug every time they see and hold the device. Therefore, research must determine the image the device is going to reflect. This type of research is commonly referred to as branding.
Branding research is typically conducted with focus groups of physicians and patients. This methodology enables identification of similar and differential perceptions. It also provides insight into the steps needed to communicate a consistent brand identity across targets. It is important for manufacturers of the device component to share this information with their pharmaceutical partner.
It is key at this stage to remember that a device does not function in a vacuum. It will probably enter the market with competing drug-delivery devices. As such, it must be positioned against the competition to highlight its advantages and downplay its shortcomings. Competitive research can be conducted through a qualitative methodology, which involves discussing key points of similarity and differentiation between a drug-delivery system and its competition. It may also involve a quantitative methodology that graphically illustrates the positioning space that the device component may occupy.
Marketing. The goals of a good drug-delivery device include accurately delivering the medication and enhancing the effectiveness of the medication being delivered. Even the most efficient drug-delivery systems can fail if they are not market friendly. With this in mind, device manufacturers should not only focus on the device's ability to administer medication but also its ability to attract users.
One objective of developing a better drug-delivery device is to demonstrate that the device is truly superior to its competitors. The advantage of a device will depend how the end-users perceive it to work. Questions to ask include the following:
• Is the device easier to use?
• Is the device unique?
• Does the device not remind the user of bad prior experiences?
• Does the device reinforce wellness and health rather than illness?
All of these issues are potential selling points and reasons to use a particular device over the competition. However, FDA requires that clinical data must demonstrate a device's safety and efficacy. Random patient interviews will not suffice when making claims about the usability of a device. As with competitive product claims, comparative device claims need to be made with users exposed to, and able to manipulate, the comparative set. In addition, if claims are to be made about the ease with which a device is manipulated, users with measurable hand deformities should test the product to ensure that all patients, regardless of physical ability, can use the device accurately. These studies involve a qualitative market research assessment to determine the perceptions of respondents with hand deformities when handling the device. However, they should also include an ergonomic analysis to be used as further evidence for supporting claims.
Final research typically consists of watching physicians and patients simulate using the device with minimal instructions, and then exploring potential issues and counterintuitive steps in the activation of the device. This research lays the groundwork for understanding how patients will use the product and for identifying specific instructions needed to prevent misunderstandings.
Once a device has been launched, research should verify prior assumptions and claims as well as identify new issues that could develop once widespread use has begun.
Implementing Research Initiatives
Many techniques have been used successfully to conduct the research steps outlined in this article. Like all devices, drug-delivery designs should be tested and refined early in the development process. The testing and refining should be based on unforeseen issues and perceptions that a hands-on demonstration will reveal. As such, research is often conducted through individual-depth interviews, which are typically held in a centrally located research facility. In this setting, end-users are recruited according to criteria that are as inclusive as possible. This technique minimizes costs, because it does not require a moderator to travel to the end-user. It also maximizes participation by team members who can attend the research and observe the interviews behind one-way glass.
When a larger and more robust sample of end-users is required, research can sometimes be conducted over the Internet. Although respondents cannot handle devices directly during such research, they can react to device features, colors, and instructions for use via streaming video and graphic presentation. This technique is more cost-effective than centrally located individual-depth interviews when the target end-user is more diverse, and when it is more difficult to find sufficient numbers of respondents in a single geographic location.
However, it is important for device and drug manufacturers to understand that the evaluation of the device and the evaluation of the drug are not typically conducted together. The device should be evaluated independently of the medication so as not to bias respondents' perceptions. Evaluations of medications are made based on trade-offs between perceptions of efficacy, side effects, and costs. These perceptions may cloud respondents' reactions to the device component of the product. This is especially true of physicians who are more focused on medication issues than they are on a medication's mode of delivery.
This is not to say that the medication should not be mentioned. Medication class and treatment category will provide respondents with needed context with which to evaluate the device.
Drug-delivery device design should be an integral part of the entire product development process. Unfortunately, because drug manufacturers' focus is predominantly on development of the medication, the device component is often overlooked until late in the development process. Therefore, device manufacturers must be responsible for communicating the importance of involving the design team early and often throughout the drug's development.
In addition, by forming strategic partnerships with custom marketing research firms, device manufacturers can not only access early clinical drug development information, but also access data vital to the device development.
A successful drug-delivery device can become more than a tool for accurately administering medication. It can become a tangible and marketable representation of the brand, and as such, can turn a good medication into a blockbuster. But for this to happen, device manufacturers must gain early access into the drug-development process.
Copyright ©2005 Medical Device & Diagnostic Industry