When determining the user needs for your medical device, you must design for your customer. There is a natural tendency to focus on the target user of the device. Who is your customer? The answer to that question is more complicated. Below are examples of medical device customers and considerations for each.
Patient: This is the person who ultimately receives, uses, or is the target of the device. This user may use the device actively, such as a glucose meter or an intermittent catheter, or may have passive interaction with the device, such as a stent or a surgical tool. The use settings can vary dramatically. When the patient needs to interact actively 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. The major difference is the interaction between the device and the person. A patient uses the device on themselves, while the caregiver uses the device on the patient.
Doctor: This is a trained professional who 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, often in the presence of fluids. For reusable devices, they also require potentially hazardous materials to not transfer between patients (cleanability)
Nurse: This customer is a trained professional who uses the device. They have the same needs as the doctor. However, they may have additional needs related to the use environment. For example, the nurse may use the device in multiple settings, such as hospitals, doctor’s offices, or homes.
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. Depending on the country or region, there may be additional requirements for packaging and labeling.
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 sizes that fit the payer schedule. For example, if Medicare covers 30 devices a month for a home patient, then the product package may only contain 30 devices).
Service Organization: We find this group is the most frequently missed customer of your product. They are important because they may be the face of the business long after the product is purchased and installed. Depending on the type of device, you may plan to replace the product or service it. If servicing the device, you need to determine whether this will be at the user’s location or through a service center. The service model may also change between countries or regions of the world.
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.
In my next blog, I will analyze the customer needs as applied to a couple of device scenarios.
Read our press release on our 1-day medical device corporate workshop on identifying and developing products for multiple customers.