Novo Nordisk

Novo Nordisk is one of the biggest insulin producers in the world. With HQ in Denmark, the company employed about 40,000 people across the globe including the EU, China, and India. Beside working on the R&D projects, I was in charge of the product and experience design for the company's first Software as a Medical device (SaMD) for NFC-enabled NovoPen 6 and the up-coming Bluetooth-enabled Insulin pen.


Role & Responsibilities

Concept Developer III

Product Design and Experience Lead

Team of risk managers, medical & science, UX researchers, data scientists, system engineers, and software developers


Business Goal

My job was to collaborate with multiple stakeholders across the globe including Denmark, Germany, UK, US, and China to create the first companion app for Novo Nordisk connected insulin pens as the first step of the company's digital health initiative.

The Challenges

Since this app was considered a medical device, it had the risk of patients' injury and death if there were mistakes in the design that lead to harm. However, due to the risk and regulations, we were unable to use release and build-release-learn iterations to fine-tune the products. The design must be perfect out of the gate and complies with multiple regulations and International standards such as IEC62304.

Along the process, I have learned how to create the safe and effective SaMD that also have a great user experience. If you wish to learn more about SaMD and the process, ready the FAQs below.

Due to the confidential nature of this project, login/password will be provided upon request. It can also be found at the top of my resume.

FAQs:

What is a Software as a Medical Device (SaMD)?

Per International Medical Device Regulators Forum (IMDRF), SaMD is a "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." This includes software that helps diagnose certain symptoms, treatment planning, or connected to medical device hardware. It also requires FDA approval and pre-market submission (510k).

What are the differences between SaMD and typical software UX/UI design?

The UX/UI design for SaMD comes with high risks that could potentially cause harm to patients. In recent years, FDA began to focus more on Human Factor and Usability Engineering of the products. In my case, if my design misguides patients to overdose, they can experience hypoglycemia which can lead to seizure, loss of consciousness, and death. So my focus is on safety and performance without sacrificing efficacy by balancing user-centered design, risk management, effective interaction design, and meticulous attention to detail.

Additionally, due to safety, the build-release-learn loop is not allowed. But at Novo Nordisk, my team and I discovered the way to do quick design iteration loops in SaMD products while complying with regulations and reduced the time required from multiple months to only a few weeks.

What are the consequences of bad UX/UI design in SaMD?

Beside patients' safety, good UX/UI design is essential for the business. The cost of a medical device recall can be up to $600 million according to 2017 McKinsey Report. At the same time, FDA estimates that 400 recalls could be prevented annually if manufacturers had better design control practices.

How to create a successful UX/UI for SaMD?

Dieter Rams's "less but better" couldn't be truer. In SaMD, every design element counts. There should not be any element that does not serve a purpose and meticulous attention to every detail is required. For example, if you are creating medication reminder UX, pay attention to potential harm. What if the users' timezone change? How do you design your app in such a way that allows patients to take the medicine correct in that situation? Is your information architecture clear and unambiguous that patients can navigate without using manual? What about accessibility? Are your patients have special circumstances such as hand and eye neuropathy? If you add any animation for delight, is there a risk if the animation stops unexpectedly? The list goes on...

With careful risk management, experience, and good design thinking, you can produce a safe and effective SaMD product. And I can ensure you, it is very rewarding. If you would like to learn more, please feel free to contact me anytime.


Due to the confidential nature of this project, login/password will be provided upon request. It can also be found at the top of my resume.


Skype for Business

Product, Visual, Interaction Design

Microsoft Teams

Design Audit, Mobile App Design

Microsoft Azure AD

UX Strategies, Visual, Interaction Design

Password required

Novo Nordisk

UX Strategies, R&D Design, Prototype

Password required

Novo Nordisk

Software as a Medical Device UX/UI

University of Washington

Marketing, Branding, Project Management

Let's make great things happen together!

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