Frost & Sullivan’s Medical Devices eBulletin
  April 2011  |  Vol. 4 Issue 2  CONNECT  

EXECUTIVE INTERVIEW

Six Questions for Care Innovation’s Bonnie Norman

  Bonnie Norman
Executive Director,
Quality Assurance & Regulatory Affairs
Care Innovations
Interviewed by Jessica Gordon


Bonnie Norman is Director of Quality Assurance and Regulatory Affairs, responsible for the quality management system processes and compliance, product quality, and worldwide regulatory affairs. With more than 20 years of in-depth regulatory affairs and quality assurance experience, Norman helps Care Innovations realize its business goals while simultaneously setting an industry example in product quality, compliance, and innovation. In the following Q&A, Norman discusses the biggest opportunities, challenges and devices to watch in home health care.


1. What’s your biggest responsibility at Care Innovations?

At the end of the day, my biggest responsibility is to ensure that all of our products deliver on the promises we’ve made to our users. Users may be clinicians, the 85-year-old woman using technology for the first time, a student in school; we must do what we say they’ll do and in such a way that will assist a person.

We take the end user validation really seriously. If we deliver a Intel® Health Guide to the 85-year-old woman who just found out she has COPD, and she’s not able to use the manual or is frustrated by the user interface, I haven’t done my job. So it’s about ensuring products are easy to use for people using them, and they do what we say they’ll do.

2. What are the biggest challenges facing Care Innovations now?

Home health is a very quickly changing industry; there’s a lot of focus on mobile platforms, new users, nonclinical users and a variety of conditions in the home environment that make it difficult to predict. The biggest challenge is staying ahead of that, understanding the market and ensuring that what we do from a regulatory quality and business point of view is one step ahead of where the market is going.

We have a large amount of research from people in the home, learning how to use our devices, so it’s not just about getting it right, it’s about understanding what problems will need to be solved that people may not know to ask about.

3. What are some of the biggest opportunities you're seeing in the field of home health care?

Care Innovation’s mission is to provide products that ensure further independence for the people who use them, and also deliver higher quality of life in the care model. It’s such a big market, the biggest challenge now is sorting through all the data to get to the core of matter. There’s a lot of noise right now with technology, iPhone apps, etc., and it’s a rapidly changing market.

4. What was the most important aspect of the Medical Devices Executive MindXchange?

At conferences like this where my peers are attending—it’s the connections, conversations, shared best practices. It’s probably the best way I have to keep current, so it’s not specifically about the takeaway, but more about networking and connections for me.

5. What's the most desirable device to bring into the home?

I have two answers: The easy answer is that it’s any device that helps you with whatever it is you’re dealing with.

More specifically, an extensible platform that is able to provide different types of healthcare and is customizable depending on your need will be essential. If you liken it to your computer in the home—you start off with the basic Microsoft, Office, but now you need to do CAD drawings or track marketing contracts. You won’t have to buy a new computer or new platform, but just the software you need, a new mouse or wireless keypad. Having that extensible platform in the home that can be customized to your specific needs is probably the most valuable because we all change with our health needs.

6. What's the most likely next device that will in fact be brought into the home?

I think we will start seeing the shifting of care from the clinical setting to the home setting. We will see some clinical devices with new user interfaces that can be safely used in the home. We all want to age in place—none of us want to end up in a nursing home. But that brings a new challenge or new responsibility in the quality of the device when a clinician isn’t the one using the device. (At home, a clinician can’t intervene if there’s a problem.) Manufacturers will be tasked with ensuring that the user interface in a home device is just as safe, it not more safe, as a clinical device.

 

 
 
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  Group shot from the 16th Annual Medical Devices, 2011. This year’s highlights included a wine tour of tello Di Amorosa in Napa Valley. (click to enlarge)  
   
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