ISO 13485:2016
DEVICE DEVELOPMENT

Nectar’s Medical Device Key Factor: Design Thinking

Made famous by the Stanford d.school, design thinking is a methodology that centers on users for problem solving. It is classically described by these steps: empathize, define, ideate, prototype, and test. Design Thinking can be applied to the development of any product, but it has an essential and powerful role in creating a medical device.

Here at Nectar, Design Thinking is heavily rooted in each sector of our development specialties, especially in medical devices. When developing a medical device, it is extremely important that your device is compatible for users, this is why Nectar conducts site visits and user feedback sessions. These User Experience research activities allow professionals like doctors, nurses, other medical personnel, as well as patients, to physically interact with the product. The insights to their workflows and mindsets are the first step to informing the design process.

Design Thinking is in our “DNA”

 Design thinking plays a key role in Nectar’s core process starting with our initial research for the project. Nectar focuses on empathizing with the product’s users. Gaining an understanding from those individuals allows us to understand their work and what their interaction with the product is like. This level of understanding helps identify pain points where there is opportunity for improvement and innovation. These thorough studies lead to the establishment of “Design Principles,” which in medical devices, are the basis for “User Needs,” a requirement in an FDA submission. 

Basis For FDA Compliance

As a methodology, Design Thinking inherently forms the basis of the type of documentation for medical devices required by the FDA. That synchronicity allows for efficient use of our 13485 Quality Management System, thus faster times to market clearance. As a result Nectar is capable of developing innovative devices such as the BreathDirect BDR-19. The BDR-19 was originally developed to meet the U.S. ventilator shortage to treat COVID-19 patients, however in order to help as many people as possible, this ventilator has been designed to meet standards for a majority of critical care operations as well. 

Development of BDR-19

During the research and design process, Nectar’s team had to make very intentional decisions about how the device would be used in a pandemic. By working with over 20 clinicians and nurses who interact with ventilators on a regular basis we were able to produce a vent that meets 90% of critical care patient needs, yet is incredibly straight forward. The device is made to be intuitive, and requires less training than more high-tech vents; in circumstances where healthcare providers are out of their own facilities, assisting in varied settings across the country this type of simplicity is extremely important. The manual knobs, switches, and placements of controls were chosen to make this device easy to use by any medical professional familiar with the standard functions of a ventilator.

Time played a key role as the demand for ventilators in the U.S. continued to rise with the worldwide pandemic of COVID-19. Even with an extremely tight timeline, Nectar refused to compromise on designing a device that was informed by user feedback. With BreathDirect and all of Nectar’s other projects, incorporating Design Thinking methodology allows our team to develop compelling products that are optimized to meet user’s needs as well as regulatory requirements.

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LEARN MORE ABOUT US
Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
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