Eric Maass, Engineering Director and Sr. Master Black Belt, at Medtronic, one of the largest biomedical companies in the world, will be one of the featured speakers at the 18th Software Design for Medical Devices Conference hosted by International Quality and Productivity Center [IQPC] on October 27-28 in Boston.

This is a specialty event recommended for medical device manufacturers, software engineers, software developers, hardware vendors, solution providers, quality assurance people, and lifecycle management experts. Also making presentations will be executives from Siemens Healthcare, GE Healthcare and Philips Healthcare – among others.

HCBN: Is this your first time speaking at the Software Design Conference?

EM: Yes, and I’m looking forward to it, I hear the IQPC people put on a good event. I know I’m going to be sharing the ‘stage’– if I can call it that – with many of the top people in software design and development, so it should be great. My part, called “Managing Risk Exposure and Reducing Recalls” is a working title; I’m refining that with my co-speaker, but it’s going to be close to what we cover.

HCBN: Can you give us a snapshot of some key initiatives you’re working on at Medtronic?

EM: We have a lot of groups at Medtronic, but let’s consider CRDM, Diabetes and Surgical Technologies groups, which represent the range of products that involve software.
For diabetes, we have products that deal with the diabetes condition “open loop” – separate products that can sense a person’s glucose level, and separately, dispensing insulin. But we are developing products that are closed loop systems for diabetics, where the sensing system is interfaced with the dispensing of insulin. The system monitors your glucose levels and automatically dispenses the medication as needed. The pacemaker – which Medtronic pioneered – is a classic example of a closed loop system. But these products also need to ‘talk’ to the doctor. The challenge is, we want to be able to keep the physician up to speed on what is going on, if the person needs an intervention or something that will actually save their life. On the other hand, we also need to be very cognizant of security.

HCBN: Security is a big issue today, isn’t it?

EM: Yes, we need to protect the patient’s information and there are actual regulatory requirements that we have to observe. But more importantly, we want to make sure the information is protected from people who are trying to hack the information, where they are intentionally trying to sabotage the communication with the physician. So we have a lot of considerations in terms of trying to make the communication available where it needs to be and also securing it and keeping it from going where it should not go.

HCBN: Can you give us an example of some of the safeguards you employ?

EM: Sure, cyber security involves the challenge of giving the physician access to get the records they need as expeditiously as possible, while protecting the patients from having their information accessed or hacked. But some of the solution is also fairly straightforward. For example, in order to get access to an implanted device, the ‘bad guys’ would have to be very close to the source, they have to be right next to the person’s body. The communication, by design, only goes a very short distance – so it is not like some unauthorized person can program a pacemaker from a mile away.

HCBN: And finally – what exactly is a Master Black Belt?

EM: We actually have two separate programs where that term is used, “Lean Six Sigma” and DRM, which stands for Design|Reliability|Manufacturability. A Master Black Belt is someone who can work with the executives – someone who understands the key goals of the organization and helps achieve those goals using the rigorous methods In terms of software, product and process development.

Editors Note: For more information on the 18th Software Design for Medical Devices Conference, visit www.sdmdconference.com/. If you would like to attend the event, mention code “SDMD_DM” for a discount on admission.