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Mechatronic Devices 

OUR SERVICES:  We have extensive experience with medical device development HW, SW, HF&E and Quality engineering, in addition to a practical understanding of the clinical application of a wide spectrum of medical devices.  We use custom checklists and proprietary tools and templates to help you efficiently assess the quality and completeness of HW, SW, and HF&E documentation (required for submission to the FDA), the degree of integration between the disciplines, and the management activities to increase mechatronics maturity in your (or your subcontractor’s) firm.  OUR PRINCIPALS: One of our principals is a licensed professional engineer (both electronics and software engineering) and former medical school professor with a doctorate in engineering management, multiple medical device patents, and 25+ years experience with embedded software development. The other is a clinician with real-world experience using medical devices and healthcare information systems. An important historical innovation in healthcare has been the advent  of mechatronic medical devices - devices that integrate sensor and effector mechanical and electrical hardware (HW) with information- driven software (SW) processes into a potentially synergistic whole, offering increasingly sophisticated functionality.  They range the gamut from simple positioning systems, to infusion pumps, to robotic surgical devices, healthcare information technologies (including medical device data systems) and in vitro diagnostic device (IVD) instruments.   While the use of mechatronics offers enormous potential for increasingly sophisticated functionality, it also presents equally large quality problems with interdisciplinary development, deployment, utilization, and maintenance.  These are not merely technical issues (e.g., promoting integration of HW and SW development by automatically generating a new hardware abstraction layer with each HW revision), but also organizational issues (e.g., preventing development from occurring in independent silos) and project management issues (e.g., emphasizing and prioritizing quality milestones over schedule and budget milestones).  How an organization deals with the HW, SW, and all-encompassing human factors & ergonomics (HF&E) issues may be viewed as a measure of medical device mechatronics maturity (see upper figure on the right and recent article by one of our principals). Mechatronics maturity may be defined as: a measure of how good you are at avoiding or recovering from the creation or propagation of System Use errors.  Testing (verifications and validation; click to see diagram) is an outcomes approach to quality; it is necessary, but not sufficient.  Quality engineers understand this well!  Inspection alone historically has proven inadequate and, in the 20th century, quality management moved successively through statistical quality control, quality assurance, and strategic quality management.  This is the process approach to quality practices; it is a management strategy that realizes that outputs are inextricably linked to inputs and transformations.  The specific processes used by medical device development organizations can help estimate their mechatronics maturity  ... and that is a predictor of new product development (NPD) quality, which is one reason why the FDA believes that quality system management audits have value. Mechatronic medical devices are the result of integration of the engineering work of various HW disciplines (mechanical, electrical, etc.), various SW disciplines (embedded, application, etc.), and - of necessity, as many are now beginning to realize - various HF&E  disciplines (micro-, meso-, macro-, and mega-ergonomics; please refer to diagram for definition of terms).  Please also refer to middle and lower figures on the right.  Practitioners of these various disciplines speak different technical languages and have very different perspectives of the engineering process; in many cases, some of the SW and HF&E practitioners have no engineering background.  This creates significant engineering management problems that are typically not resolved with standard project management methods.  Some pretend that these are problems with the HW, SW, and HF&E practitioners; in fact, they are engineering management problems!  
Samaras Medical Device Mechatronics Development Diagram Samaras Medical Device Development State Space Samaras Medical Device Mechatronics Maturity Model
Permitting HW, SW, and HF&E work to proceed un-integrated in individual "silos" is a regressive engineering management approach that thwarts efficient communication & coordination, thwarts the effective implementation of design controls, and invariably reduces quality of the developed product, process, or service - stifling innovation. Why should mechatronics maturity be of concern to you? It directly impacts economic, technical, and operational risk.  NPD presents a set of engineering management trade offs among the four basic NPD attributes: budget, schedule, scope, and quality.   A low maturity NPD process is more costly and less time efficient; trading off scope and quality against budget and schedule will reduce market share and increases future liability.  Development processes that have traded off quality in favor of budget and/or schedule invariably yield devices that suffer a greater incidence of safety and effectiveness problems; some can be the source of significant corporate liability.  A high maturity NPD process is quite cost and time efficient, permitting the developing organization to focus on maximizing scope and quality … and market share.  
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