The complexity of medical devices is rapidly increasing, enabled by innovations in technology. This same technology has enabled health care to expand from institutional environments to home care and mobile environments. Software plays a critical role in controlling these devices. It is essential that the dependability of these devices is assured because many of them are safety critical; i.e. can cause serious injury or death.

Modeling and simulation of device designs is emerging among medical device manufacturers as a technique to help address such challenges. Modeling and simulation has a long history of improving product quality by helping designers to detect defects that may be overlooked in a traditional software development workflow. For example, design requirements can be modeled, and then the model checked for properties of requirement consistency and completeness. Subsequently, the model can be run in-silica permitting rapid-prototyping and comprehensive real-time checking of...

References

References
1.
Kovatchev
,
B. P.
,
Breton
,
M.
,
Man
,
C. D.
, and
Cobelli
,
C.
,
2009
, “
In Silico Preclinical Trials: A Proof of Concept in Closed-Loop Control of Type 1 Diabetes
,”
J. Diabetes Sci. Technol.
,
3
(
1
), pp.
44
55
.
2.
Continuous Glucose Monitoring and Closed-Loop Systems
, Havorka, R., s.l.:
Diabetic Med.,
23
, pp.
1
12
.
3.
Multicentric, Randomized, Controlled Trial to Evaluate Blood Glucose Control by the Model Predictive Control Algorithm Versus Routine Glucose Management Protocols in Intensive Care Unit Patients
.
Johannes
Plank
,
Jan
Blaha
,
Jeremy
Cordingley
,
Malgorzata E.
Wilinska. Alexandria
, Virginia: American Diabetes Association,
2005
.
Diabetes Care.
Vol.
29
.
4.
Reduction of Number and Duration of Hypoglycemic Events by Glucose Prediction Methods: A Proof-of-Concept In Silico Study
,
Chiara
Zecchin
,
Andrea
Facchinetti
,
Giovanni
Sparacino
, and
Claudio
Cobelli
.
Diabetes Technology & Therapeutics
.
5.
Kuhn
,
Dolores R.
Wallace
and
D.
Richard
.
Lessons from 342 Medical Device Failures
. Gaithersburg, MD: Information Technology Laboratory,
National Institute of Standards and Technology
.
6.
When code can kill or cure. The Economist, Jun
2nd
2012
.
7.
Applying STPA to the Artificial Pancreas for People with Type 1 Diabetes, Lane Desborough, Medtronic http://tinyurl.com/usingSTPA
8.
Case Studies of Modeling and Simulation Used in the Design of Devices Such as Emergency Ventilators (Weinmann Medical Technology) and Infusion Pumps (Medrad).
You do not currently have access to this content.