Current Project

Novo Nordisk

Software as a Medical Device UX/UI

Skype Design US

At Novo Nordisk, I collaborate with researchers, software engineers, mechanical engineers, data scientists, regulatory bodies, and other stakeholders to bring solutions such as AR/VR, machine learning algorithms, sensor interface, mobile app, personalized medicine, and many others while complying with multiple complex standards and regulations for software as a medical device such as ANSI/AAMI/IEC 62304, 82304, and 14971.

Additionally, I also lead the UX/UI design of next-generation devices and digital therapeutics for multiple user types such as payers, HCPs, patients, and nurse educators.


Due to confidential nature of this project, login/password will be provided upon request.


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 confidential nature of this project, login/password will be provided upon request.


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