Who is your medical device customer and how to identify their needs

How To Identify Medical Device Customers and Their Needs

Identify the customer

Successful medical device product development requires you identify and address your customer needs. Product development has a tendency to focus on the target end user or recipient of the device when developing products, but it isn’t that simple. There are other customers that must be considered. Below are some medical device customers and considerations for each when developing products.

  • Patient: This customer ultimately receives, uses, or is the target of the device. They may use the device actively, such as a glucose meter, or may have passive interaction with the device, such as a surgical tool. The use settings can vary dramatically. For active interactions with the device, you need to consider the user’s skill level, physical ability, and the use environment.
  • Unskilled or family caregivers: These customers help the patient use the device. The skills and environment are often similar to those of the patient.
  • Doctor: This trained professional uses the device and often participates in the recommendation or purchase decision of the products. This customer expects the product to work as intended in the clinical setting.
  • Cleaning for reuse: This customer is usually at a hospital or a third party company and is not trained in the use of the device. They need to quickly and easily remove any contamination from the device so it can be used safely on the next patient. Because of the diverse set of devices to clean, the procedure must be easy to use and not too specialized.
  • Payer: This customer pays for the device. Examples of payers include an insurance company, a public health agency, or a purchasing group in a hospital. Their focus is often on the economics of the device in a given setting.
  • Distributor: This customer manages device inventory for their users. Often these are consumable devices that need to be replenished on a regular basis. Distributors look for product packaging and labeling that fits their inventory management system, such as stackability, labels that are easily read for automated picking, and package configurations that fit the payer schedule.

Once the customer has been identified

Once the customers are identified, you need to determine how they will use the product and determine what their needs are. The following steps are helpful to identify the needs.

  • “Follow” the device from its initial delivery to first use, then to its next use. In a home use setting this may be very limited. However, in a hospital setting, the device may move through many departments from inventory management to clinician use to decontamination back to inventory management. This process of “following the device” enables you to identify all the users.
  • Once the users are identified, determine how each one interacts with the device. Use cases and use case diagrams are excellent tools to help you understand how the user interacts with the device. Where possible, confirm these interactions by direct observation, which can be done on a similar product and throughout development as part of confirming usability, which is described in the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices.
  • Identify additional use environments and repeat the above steps.

The example below helps illustrate how the user and their needs may change based on the device use.

Blood glucose meter, pocket size

This common medical device is used by many different types of users. The meter and strips are typically supplied to the user in a box from a pharmacy or diabetic supply company. Once delivered to the user, there is no additional movement of the device to other users or types of users. In this scenario, focus on the users, their required performance for the intended use, and all the different environments.

Home users of a glucose meter may include a parent testing a pediatric patient, an active adult, and an elderly user. Any of these users may also have limited dexterity and/or eyesight. Another primary user is a clinician who provides point of care services. These services may be through home care services or in a clinical setting, such as a nursing home.

Starting with the active adult, determine how and where they will use the device. They may use it in multiple locations: home, school, or job. The device must be portable to go many places. It may sit in a car when not being used, so the meter and the strips may be exposed to wide temperature and humidity variations. An elderly user may use the device only in the home. Issues with neuropathy, manual dexterity, and the ability to read information on the display can affect their correct use of the device. A meter being used by a clinician may have a more controlled physical environment, but needs to prevent contamination between patients, usually through a decontamination process.

In October 2016, the FDA released two guidance documents related to portable blood glucose meters. The first guidance document is Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use . This guidance document describes lay users and inhome use. The second guidance document is Blood Glucose Monitoring Test Systems for Prescription Pointof-Care Use. This guidance document discusses glucose meters used in professional healthcare settings, such as nursing homes. The FDA points out that the use settings and use populations differ significantly, which manufacturers should consider when designing their devices.

When developing your medical device, it is important to understand who all your customers are and what they need from a device. Focusing on only the intended user will affect other customers who use your device. By designing your product with all your customers in mind, you develop a more robust and usable device.

You may find conflicting user requirements based on your analysis. These conflicting user requirements should be resolved based on the intended use and target markets. Once the use has been explored and the user needs identified, capture the actual requirements and build traceability between the user needs and the design inputs (or product requirements.)