Kenneth J. Fuchs

Home:                                                                                                                       ken.fuchs@ieee.org                                                                         Work: Draeger Medical Systems

126 Woodridge Rd.                                                                                                                                                                                                                       6 Tech Drive

Wayland, MA 01778                                                                                               (508) 314-5652 (mobile)                                                                            Andover, MA 01801

Senior Technology Leader

Expertise, leadership and proven track record developing US and international standards (ISO, IEC, AAMI, HL7, IHE) in the areas of Medical Devices, Personal Health Devices, IoMT and other aspects of Digital Health and Interoperability.  Veteran of numerous successful product development projects in the areas of Medical Equipment and Clinical Information Technology.  Holder of both MBA and M.Eng degrees.

DRAEGER MEDICAL SYSTEMS, INC, Andover, MA                                                                           

Sr. Standards Consultant – Clinical and Interoperability Standards                            1/2020 – present

Senior expert Draeger relevant clinical and interoperability related standards

• Coordinate the participation of Draeger technical experts on various Standards efforts.
• Member of the Draeger International Standards Management (ISM) team
• Consult with various product groups as required on standards relevant to their products.
• Participate in various Draeger strategic open standards efforts:
• Chair of the IEEE 11073 Standards Committee – Health Device Interoperability
• Co-Chair of the AAMI Patient Monitoring WG (Mirror to IEC JWG22)
• Co-Chair of the IHE DEV(ices) DPI (Device Point of Care Integration) Program
• Member of the IHE International Board of Directors
• Secretary of the IEEE/UL P2933 TIPPSS (Trust, Identity, Privacy, Protection, Safety, Security) for Clinical IoT WG
• Co-leader of the ISO/TC 215 TS 5615 standard for Remote Connected Care and Mobile Health
• Member of AAMI Standards Board
• Contributor to the AAMI WG03 Interoperability and AAMI/UL 2800 Safe Interoperability Standard WGs

Director – Standards and Process Management                                                         1/2017 – 1/2020

Senior leader for patient monitoring and systems-oriented Standards and Process.

• Work with Leadership to determine Draeger’s Standards strategy.
• Coordinate the participation of technical experts on various Standards efforts.
• Coordinate the management and maintenance of Draeger’s internal innovation processes.
• Participate in business relevant standards development activities including digital health, medical device and clinical information exchange

CENTER FOR MEDICAL INTEROPERABILITY, Nashville, TN                                                             

Distinguished Fellow – Medical Interoperability                                                        12/2015 – 1/2017

Senior technical leader for the Center for Medical Interoperability

• Recruit and manage collaboration groups of vendors, providers and other interested parties around the Center’s key initiatives.
• Contribute to and manage the Center’s involvement in medical device and digital health interoperability efforts.

Executive Vice President – Interoperability R&D                                                    11/2013 – 11/2015

Responsible for Center for Medical Interoperability R&D programs

• Manage the Center’s R&D program, product roadmap and strategy.
• Build and manage a team of SW developers to create, release and support open source software solutions for medical interoperability for incorporation in medical devices and system platforms.
• Lead the Center’s Technical Advisory Council of Member (healthcare industry) CIOs and CMIOs.

MINDRAY NORTH AMERICA, Mahwah, NJ                                                                                         

Sr. Principal Scientist – Technical Research Institute                                               1/2013 – 10/2013

Responsible for Mindray’s Technical Research programs

• Develop Mindray’s technical roadmap and strategy.  Identify internal resources and external partners to address technical product opportunities.
• Lead Mindray’s participation in International Standards development projects and present at relevant conferences concerning medical systems interoperability.

Sr. Principal Architect – Enterprise Systems                                                            7/2010 – 12/2012

Responsible for Enterprise Systems product line architecture and strategy. 

• Develop product, business, architecture and development strategy for next generation of Mindray medical device and IT products, working closely with US and Chinese resources.

DRAEGER MEDICAL SYSTEMS INC., Andover, MA.

Principal Engineer – Systems Engineering and Architecture                                       1/2008 – 7/2010

Responsibilities include leadership of the Central and IT products architecture initiative.  Management and sustaining effort related to all Draeger networking solutions and infrastructure partnerships.

• Manage the transition to Wireless LAN technology for multiple products.
• Architecture consultant to various development projects, Draeger-wide.
• Manage strategic alliances with connectivity, network infrastructure and other technology partners.
• Organize Draeger Medical’s presence at the HIMSS IHE Showcase.

Director – Clinical and Systems Engineering                                                           10/2004 – 12/2007

Responsible for Clinical Engineering (requirements engineering, clinical validation, clinical partners) efforts for; Draeger patient monitoring and IT products.

• Improved predictability of delivery against schedule of IfU documents by 3 months.
• Improved consistency, modularity and traceability of requirements to final product “V&V” efforts.

Program Director – Critical Care Information Technology (IT)                                    7/2003 – 10/2004

Program Management (R&D and Upstream Marketing) of Draeger IT products for the Critical Care Market.

• Led multi-site team developing and marketing entry-level Information System (Innovian).  Developed specific subset for Siemens Medical Solutions Soarian product line.
• Developed strategic alliances for OR Scheduling, Pre-op Assessment and Emergency Care IT.

SIEMENS MEDICAL SOLUTIONS INC., Danvers, MA

Program Development Manager – Critical Care Information Technology                   8/1999 – 06/2003

Developed a new strategy and role for Siemens Medical Systems in the area of Clinical Information Systems (CIS).  Presented results to the Board of Directors leading to responsibility for its implementation.

• Built strategy, business model and development team for Clinical Information System.
• Improved relationship with existing Clinical Information System vendor (Picis), and increased customer satisfaction from 30% to 90% over 3 years.
• Negotiated strategic alliances for Multi-Gas monitoring and Device Connectivity solutions.

Product Line Manager - System Products and Systems Engineering                         10/1996 – 8/1999

Managed a 50-person team responsible for the development, marketing and manufacture of Siemens System Products with a yearly turnover of ~$25M (cost basis).

• Managed development of the Infinity Docking Station resulting in a cost reduction of 60%.
• Proposed and managed development of Siemens Gateway to interface to HL7 based systems.
• Managed enhancements to Siemens’ UNIX based MVWS and CRS product lines.

Section Manager / Sr. Section Manager - Central Products and Systems                   4/1989 – 9/1996

Supervised the engineering team and cross-functional teams responsible for the development of PC platform-based products including a new Central Stations and Full-Disclosure stations.

• Developed Siemens Infinity Network - currently (still) recognized as the “best in breed”.

• Strategic planning and management of Siemens’ 3rd party device connectivity strategy.

HEWLETT-PACKARD INC., Medical Electronics Division, Waltham MA.                     8/1975 – 4/1989

Various Positions – Patient Monitoring                                                                                                

1986 - MBA in Marketing and Finance - High Distinction. Babson College, Wellesley, MA

1975 - M.Eng. in Bio-Medical Eng. – Summa Cum Laude - Rensselaer Polytechnic Institute, Troy, N.Y.

1974 - B.S. in Bio-Medical Eng. (EE Focus) – Cum Laude - Rensselaer Polytechnic Institute, Troy, N.Y.

Various Continuing Education Courses relating to Management and Technology.

• Holder of 4 US and 3 European patents.
• International Expert for standardization of medical device and healthcare IT systems interoperability:
• Past co-chair IHE Patient Care Devices (PCD) Domain Planning Committee
• Frequent presenter at HIMSS, AAMI and other healthcare technology conferences
• 2014 American College of Clinical Engineering Professional Achievement in Technology Award
• 2020 ACCE-HIMSS Excellence in Clinical Engineering and Information Technology Synergies Award
• Contributor to “Mobile Medicine – Overcoming People, Culture, and Governance”, Routledge: 2021