Carolien Creemers and Maarten Bressinck work as functional designers at Nobel Biocare, focusing on user experience and interaction design for digital dental solutions. They discussed challenges with designing medical software due to strict regulations and outlined Nobel Biocare's process, which incorporates agile development methods and user research like field studies and usability testing to ensure safety and meet regulations. They provided examples of their solutions, like using cards to visualize dental lab workflows and mapping surgical cuts onto a digital tool.

1. Carolien Creemers, Maarten Bressinck
27/09/2016
UX DESIGN FOR BETTER
PATIENT CARE

2. Who we are
Carolien Maarten
Carolien is a functional designer at Nobel
Biocare. With a background in biomedical
engineering she focusses on user
experience and interaction design in the
field of digital dental solutions.
Maarten is a functional designer at Nobel
Biocare with a background in Digital
Design and Media (Devine). Maarten
worked as a UX designer in Cambridge
and London and lectured UX and
Interaction design at the University College
of West-Flanders.

3. https://www.youtube.com/watch?v=aHjI3f92Q9w
VIDEO
AIR FRANCE FLIGHT 447
June 1, 2009

4. The consequences of bad design
Official investigation concluded
that human error caused the
deadly Air France 447 plane crash.
Later evidence however shows
that the pilots of the Airbus
A330-200, and everyone else on
the plane, were in fact victims of
bad design.

5. Dominated by computers, Airbus
designed its planes with less
tactile response.

6. HOW BAD UX DESIGN KILLED JENNY
Source: https://medium.com/tragic-design/how-bad-ux-killed-jenny-ef915419879e#.rh323z8eg

7. How bad design killed Jenny
Jenny (fictional name) was a little
girl that had to get a very strong
chemo therapy. It was crucial that
she would get 3 days of I.V. fluid
after treatment to avoid
dehydration.
Tragically three experienced nurses
missed the information due to bad
design causing the girl to die.

8. “We can’t stand by while people’s
lives, health, rights suffer
because of bad design”
Jonathan Shariat

9. At Nobel Biocare we also design for
critical environments where a
patient’s wellbeing is at stake.

10. SOME EXAMPLES

11. What is implant surgery
During implant surgery a missing tooth is replaced
with an implant (the tooth root) and a crown.
This process exists out of two steps:
1. The implant is drilled into the patients mouth. A
temporary crown can be placed on top of the
implant.
2. After the implant and soft tissue have health the
patient comes back and the final crown is
placed on top of the implant.
NobelClinician

12. NobelClinician
NobelClinician is designed to digitally
plan an implant treatment. The dental
surgeon can digitally plan where he is
going to drill the implants into the patient’s
mouth.
From this digital treatment a surgical
template can be generated for use during
surgery to guide the dental surgeon.

13. Risks and how our software can help
Implant surgery poses risks to the patient. If for
example the dental surgeon does not notice
that his planned implant penetrates a nerve he
might permanently paralyze the patient.
It is also important that the implants don’t
penetrate the sinus cavities since this can
cause infections an discomfort for the patient.
Using the software the surgeon can see a 3D
model of the patients head.
NobelClinician

15. OsseoCare Pro
The OsseoCare Pro app was designed to
guide the user while performing implant drills
in the patient’s mouth. The app shows which
drills need to be used and the speed (RPM).
While crafting the design, hygiene was
flagged as a risk. Medical equipment needs
to be sterile so touching a screen is not an
option. Therefore pedals were added so that
the app could be used without touching the
device.

16. OSSEOCARE DEMO

17. ABOUT NOBEL BIOCARE

18. About Nobel Biocare
Nobel Biocare is a world leader in the field of
innovative implant-based dental restorations.
Nobel Biocare became part of the Danaher
Corporation, a global science and technology
innovator committed to helping its customers
solve complex challenges and improving
quality of life around the world. The company
has around 71.000 associates.

19. Mahwah, USA
Production
Mechelen, Belgium
Software development
center digital dentistry
Zurich, Switzerland
HQ
Dental companies within Danaher
Within NobelBiocare
We are currently
growing and it is our
ambition to design and
develop software for all
these dental
companies.

20. DESIGNING FOR MEDICAL

21. Of course you cannot just simply put a
medical device on the market. There are
strict regulations and systems in place in
order to regulate this. These regulations are
region based for now we’ll highlight two of
them.
Regulations for designing medical devices
• FDA Standard (Food and Drug Administration) - U.S.
Focused on protecting public health, provides a clear process and regulations
• IEC (62366) - EUROPE
Focused on device usability

22. From time to time you read in the
newspaper that a new drug or treatment
received FDA approval status usually
meaning that it will enter the market soon
after.
This waterfall FDA process, has a big
impact on how we design and develop our
products here in Mechelen. We will explain
how we map this process on our workflow
in the next slides.
The FDA process
User
Needs
Design
Input
Design
Process
Design
Output
Medical
Device
Verification
Review
Validation

23. The IEC 62366 is a “revolutionary” standard
(introduced in 2012) within the classical medical
industry. It focusses directly on interface design
and possible patient risks that comes with poor
design.
The IEC 62366 is a guideline that is very patient
centered and focused on usability. It also pushes
the medical device industry to do thorough
usability testing. Which is also really important to
us.
IEC 62366

24. Following the exact specifications doesn’t directly mean
that you’ll get approval to launch (e.g. you can follow the
process and still create a potentially dangerous product).
Following the process doesn’t always
end in clearance
The FDA system is proactive, once you get clearance
you can put your product onto the market.
The IEC system on the other hand works postrelease,
you can release a product once the documentation has
been provided but if criteria aren’t met a product might
be recalled.

25. A process is a guide not a
solution. There are some specific
challenges when designing
medical devices.

26. Challenge #1: Long time to release to market
Complex desktop applications are not made overnight.
For some products it takes years of development
before they are complete and even when a product is
ready you need FDA clearance before you can launch
a medical device on the US market.
This process takes at least 6 months and the product
has to go through a product validation phase. You
need an agreement from the FDA and even for
updates the same rules apply, once the features or
product scope changes, you’ll need clearance.

27. Challenge #2: Getting
customer feedback
Since we develop desktop applications we cannot just
include Google Analytics or other surveys into our
software. Our clients live across the globe and since
we don’t want to add too much to global warming we
don’t take the plane for a one-hour usability test.
On top of that dentists and doctors almost never have
time. Ever tried booking an appointment with your
dentist for next week?

28. Challenge #3: Designing for experts
Many of our users are top dental surgeons in their
respective fields, they have developed their own
techniques and approaches to perform surgeries.
It is very hard to define the exact functional
requirements for all these different approaches and
visions.
Note: Some of them are also very competitive.

29. Testing medical devices is always
challenging, we have to be certain that our
software and hardware is safe to use before
doing clinical trials.
To do this we have strong connections with
a number of dedicated and experienced
dental surgeons who are able to identify
risks and problems. Often these trials are
filmed and broadcasted (live surgery).
Challenge #4: Testing medical devices

30. Challenge #5: Identifying ourselves with
our users is a challenge
Our design team is multidisciplinary with
people from different backgrounds (ux
designers, (bio)-engineers, etc.) but
because our target user group is very
niche yet diverse it is hard to identify the
exact user need and set yourself in the
position of a highly qualified dental
surgeon.

31. HOW WE TACKLE THESE CHALLENGES

32. Functional Design
Development
Project Owners
Software Testing
Validation
Research
Technical Writing
Quality Assurance

33. We use agile (scrum) methodology!
We can identify a number of clearly defined
phases that a project goes through.
Problem: this process is very development
centered and it works very well from that point
of view but incorporating UX is a challenge.
* Usually we have about 6 2-week sprints per project
Preparation
Sprint
1
Sprint
2
Sprint
x
Stabilization Validation

34. How we incorporate Scrum and UX
To do this we map a regulated UX process
on top of our agile scrum methodology.
Preparation
Sprint
1
Sprint
2
Sprint
x
Stabilization Validation
+
• Field studies
• User interviews
• Competitive analysis
• Conceptual design
• Prototyping
• Formative testing
• Detailed interaction design
• Brief summative testing
• Detailed summative usability
testing
• Report usability findings

35. Some of our UX deliverables

36. We can do interviews all day at our offices but
that still does not give us a real idea about how
it feels to actually use our products in a real
environment.
To get the feeling of what it is to drill an implant
into a patient’s mouth or to perform a
maxillofacial surgery using splints we get the
opportunity to attend an actual live surgery to
see our customers and products in action.
We join surgeons in the surgery room
* And even developers can join.

37. At specialised dental or maxillofacial
conferences we have all our fish in one
bowl. It is an ideal opportunity to
connect with our users.
At these events we often try to set up
interviews with surgeons / clinicians that
would otherwise be hard to tackle.
We go to medical conferences and meet
our users

38. Patient risk mitigation
During our preparation (so before any design /
development work has taken place) we create a
map which contains all features of a project. This
map works as a guide to do an initial patient risk
analysis of the upcoming project.
During the project the development is closely
monitored by the stakeholders to see if no new risks
are being introduced.
At the end of a project we do another validation to
see if the patient risks have been properly mitigated.

39. We document everything
Yes, we have to provide a lot of
documentation, luckily we have a lean
documentation solution. All these
documents (e.g. user stories) are stored in
a database so that documentation can be
generated automatically.
We create documentation as we are
moving forward without actively investing
too much time in writing documents.
Test cases
User story
Feature
User Need

40. We cannot just put a product onto the market
and hope for the best. We have to make sure
that our product is safe and works correctly.
When launching a new product, we work with
staged launches. Usually we start with a small
beta test across a handful of users (that actively
communicate their feedback).
Later on the sample size of the beta will be
increased and eventually a full launch will take
place.
We do staged launches

41. Challenge
Design a solution that makes it easy to
visualize a case workflow in a dental lab
environment.
Solution
We mapped out the workflow and identified a
number of different steps.
With some inspiration from Google’s Material
Design we created a card based timeline that
guides lab technicians through their cases.
Case study 1: NobelDesign cards

43. Case study 2: Osteotomy cuts
Challenge
Creating a digital tool to do cutting in
bone (osteotomies). The tool has to be
intuitive, and translate to the way
surgeons work.
Solution
We looked at surgeries and the way
bones are cut. We mapped this onto a
digital solution

44. This all sounds very serious
but fun matters!

45. CONCLUSION

46. Conclusion
• The biggest challenge is implementing UX in a very regulated environment. This poses a
lot of complexities and we keep growing and learning as we move along.
• On a UX level in the medical field we are a bit of a pioneer.
• We try to mix medical seriousness and try to apply the latest design trends, even surgeons
like cool products (e.g. they are into the latest wearables and smartphones).
• Our users often invest a lot of money in a nice looking practice, it is important that our
software blends in with these environments.

47. Takeaway
It might be a weird thing to say but UX designers
are a rare (and almost non-existent) profile within
the medical software field.
With a lot of our competitors, developers are also
responsible for the design. One of our strengths
is that we have a team of dedicated designers
which focus on understanding the end user and
transferring their needs into design solutions.

48. Questions?

49. That’s all!
Thank you for joining us today. Have
a drink, and perhaps play around
with our software on the demo
machine we have setup.
Additionally we would like to mention
that we are growing and looking for
new people to help us shape the
future of digital dentistry. For more
info talk to us or visit:
http://www.nobelbiocarejobs.be/