This document summarizes an Agile roundtable discussion moderated by Kelly Weyrauch on applying Agile practices to medical device development. It introduces the panelists which include experts from Spok, Bigfoot Biomedical, Babyation, and Agile Quality Systems. The panel then discusses how Agile is changing medical device development, benefits they have seen from Agile, challenges of satisfying regulations, tools to support Agile, reasons for investing in the codeBeamer ALM tool, and advice for evaluating Agile tools.

1. Agile in Medical
Technology
Roundtable Discussion
Moderated by Kelly Weyrauch,
Agile Quality Systems
26 Sep 2018

2. 2
About Intland Software
• Founded in 1998
• Headquarters in Stuttgart, Germany
• Office in Silicon Valley, USA
• Resellers in the US, UK, Korea,
China, Brazil, Hungary

3. 3
Kelly Weyrauch
Agile Quality Systems
Kelly Weyrauch has worked than 25 years in
the use and development of software processes
and quality systems for medical devices. As an
independent consultant, he works with software
and systems creators to apply Agile concepts
and Quality Management System requirements
to the unique context of their development
environment. As one of the principal authors of
AAMI TIR45 Guidance on the use of Agile
practices in the development of medical device
software, Kelly has worked with the FDA and
industry leaders on the application of Agile
practices to the medical device world.
Today, he is an independent consultant through
his own company, Agile Quality Systems.

4. 4
Sarb Singh-Kaur
Spok
Sarb Singh-Kaur has over 18 years of experience
driving cutting edge innovation in the Data Storage,
Data Protection, Medical Devices, Healthcare and
Telecom industries. He’s worked with Fortune 500
companies, and as a senior software engineering
leader, he has driven the Agile transformation at
Medtronic Neuromodulation.
Today, he is the VP of Software Engineering at Spok,
a leading company in clinical communication
solutions.

5. 5
Alan Schachtely
Bigfoot Biomedical
Alan is an experienced software director who has
worked with companies like GE before joining Bigfoot
Biomedical. The Milpitas, CA-based startup company
is developing a connected ecosystem of medical
technology to manage diabetes care.
Alan has a proven track record of building and leading
high performing Agile software development teams,
and runs a rigorous lean Agile shop at Bigfoot.

6. 6
Jared Miller
Babyation
With extensive experience in system integration, IT
engineering, and software development, Jared is an
expert in the implementation of emerging
technologies. Running his own software and
technology consulting firm for over 10 years, he has
supported the implementation of quality systems and
change management practices at a number of
organizations.
Jared started Babyation in 2015 with his wife to bring
innovative, tech-driven solutions to parents. He was
involved in developing the circuitry, microcontroller
firmware, and related software behind Babyation's first
product, a discreet and quiet breast pump.

7. 7
Intland Software’s Roundtable Discussion
Agile in Medical Technology
How do you see
Agile changing the
development of
medical devices and
the medtech industry
as a whole?
1.

8. 8
Intland Software’s Roundtable Discussion
Agile in Medical Technology
What benefits
have you seen
from your
organizations use
of Agile?
2.

9. 9
Intland Software’s Roundtable Discussion
Agile in Medical Technology
How does the
need to satisfy
regulations affect
your application
of Agile?
3.

10. 10
Intland Software’s Roundtable Discussion
Agile in Medical Technology
How does Agile affect the
use of your current tools,
and what are you looking
for in new tools to support
an Agile way of working?
4.

11. 11
Intland Software’s Roundtable Discussion
Agile in Medical Technology
Why did you invest in
an ALM tool like
codeBeamer ALM?
5.

12. 12
Intland Software’s Roundtable Discussion
Agile in Medical Technology
What final recommendation
or advice would you give to
someone who is evaluating
tools to support their Agile
development practices?
6.

13. Audience
Questions &
Anwers

14. Contact:
sales@intland.com
Kelly Weyrauch
kelly@agilequalitysystems.com
Sarb Singh-Kaur
sarb.singh-kaur@spok.com
Jared Miller
jared@babyation.com
Alan Schachtely
aschachtely@bigfootbiomedical.com
intland.com/download-codebeamer/
30-Day Free Trial
intland.com/medtronic-case-study