The World Health Organization predicts by 2015 that 2.3 billion people around the world will be overweight and 700 million will be obese.  The growth rates for weight issues in the U.S. alone has tripled since 1980.  Ouch!  But, Americans aren’t alone in their growing waist lines.  Many other developed countries are experiencing increasing obesity rates as well.  Despite billions being spent every year on weight loss products, few people actually achieve the long-term results they need to reduce their weight to a healthy range.  Thus, obesity is reaching epidemic proportions and remains one of the biggest global healthcare issues today.  Hmm, starting to feel a little guilty about eating that 2nd doughnut?

IntraPace, a medical device company based in Mountain View, California, is working on an innovative product that is tackling obesity in a new way.  Backed by Johnson & Johnson, Boston Scientific and other investors in healthcare and bioscience, Intrapace is developing the first “intelligent” implantable device for obesity intervention called abiliti, which is currently in clinical trials in Europe and not yet available in the marketplace.  As the product team at IntraPace develops this unique medical device, they’re managing all the requirements, both hardware and software, along with its related documents within Jama Contour – enabling them to control changes and keep everyone in sync.

I searched through many solutions and Contour was by far the best implementation of a tool for managing requirements.  It is simple to use and intuitive to learn. - Mace Volzing, software development manager, IntraPace

Recently, I spoke with Mace Volzing, the software development manager at IntraPace and asked him a few questions about his team’s use of Contour and their process for developing products.

What are the goals of the projects you’re managing within Contour?  Tell us a little about your role and the new product your team is building?

I manage the software development for our new abiliti medical device that is used by people to lose weight.  Once implanted, the abiliti system is designed to detect when a person consumes food and drinks.  Using sensors, the system tracks what they eat and their physical activity, then it uses this information to delivery therapy at the right time and monitor the patient’s progress against weight loss goals.   It works using what is called “gastric stimulation” by delivering a series of low-energy electrical impulses to the stomach to give a person the feeling of being full before they actually are full, thus helping them consume fewer calories.  Most people often eat until they feel full, so abiliti acts as a kind of an internal gatekeeper between them and the Supersize Fries they don’t need.  The system then also provides a detailed picture of the data, which can be downloaded and reviewed by patients and their physicians at the doctor’s office to track results over time.

In terms of Contour, I was looking for a tool to manage the flow of requirements from a Marketing Specification to System Requirements down through to the detailed hardware and software requirements, and finally to validation of Test Plans.  Keeping the interactions between all of these documents up to date is a challenge and finding the right tool makes a laborious task painless.  Contour is the right tool, we use it to manage all of our requirements.

What development process do you use?

In the medical device world, requirements documentation is very important for compliance.  It all starts with a Marketing Specification and flows down to a Product Requirements document.  We have design descriptions, API definitions, risk analysis and validation test plans all being managed and kept in sync by Contour.  All of the documents are cross-referenced for traceability, and Contour makes keeping these relationships up to date an easy task.

What’s the biggest challenge you and your organization face in managing this process?

Change!  Any single change can ripple through many different documents.  Having a way through Contour to manage the “ripple effect” is incredibly valuable.

Why did you choose Contour?  How is Jama helping you be more successful?

I searched through many solutions available for this capability and Jama Contour was by far the best implementation of a tool for managing requirements.  It is simple to use and intuitive to learn.  I was able to get our entire staff to buy into using the tool within 3 weeks of launching the software at our company.

What were you using before Contour to manage requirements?

Word documents and needles in my eye.  Actually I was lucky, I came into this project at the right time and was able to secure Contour in the early stages of development.  Contour is one of the best tools we have added to our process!

Bonus question:  What’s your favorite band of all time?

That is a tough question.  My taste in music constantly changes… Right now I’m a big fan of The Fray or Maroon 5.

Thanks Mace for your insights and sharing your story with us.  Good luck with the clinical trials, I think those who struggle with serious weight loss will be anxious to see abiliti hit the market as an alternative to other surgical procedures such as gastric bypass.  Personally, I’m thinking I’ll have to skip the Honkin’ Huge burrito cart today and go running at lunch instead.  Here’s to good health (and the occasional doughnut)!

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