Malcolm Baldrige Criteria for Performance Excellence in the

Malcolm Baldrige Criteria for Performance Excellence in the Medical Device Industry Dickson Consulting 351 Old Babcock Trail Gibsonia, PA 15044 724 -272 -1527 rdickson@nauticom. net 10/23/2021 Dickson Consulting 1

Malcolm Baldrige Criteria • Top down approach • Leadership in each functional area of the organization • Intended to promote quality, not simply an award • Fits well with medical device industry regulatory requirements • Additional information on Malcolm Baldrige National Quality Award (“MBNQA”)—www. baldrige. nist. gov/ 10/23/2021 Dickson Consulting 2

Medrad Inc. -Medical Device Company That Won MBNQA • Medrad is a provider of medical devices and services that enable and enhance imaging procedures of the human body. Used in diagnostic imaging, Medrad's product offerings include a comprehensive line of vascular injection systems, magnetic resonance surface coils and patient care products, and equipment services. Total 2005 revenues were $411 million. • Medrad is a 2003 recipient of the Malcolm Baldrige National Quality Award. • The company’s world headquarters is near Pittsburgh, Pennsylvania. Medrad is a U. S. affiliate of Schering AG, Germany (NYSE: SHR). • Additional information on the Medrad’s award: -www. medrad. com/about-medrad/mbnqa/index. html -www. nist. gov/public_affairs/baldrige 2003/Medrad_3. 3. 04. pdf 10/23/2021 Dickson Consulting 3

Specific Baldrige Criteria • Baldrige criteria available for: -Business (a medical device company perspective) -Health Care (a medical device company customer perspective) 10/23/2021 Dickson Consulting 4

Baldrige Criteria for Performance Excellence • • Leadership Strategic planning Customer and market focus Measurement, analysis and knowledge management • Human resources focus • Process focus • Business results 10/23/2021 Dickson Consulting 5

Why Baldrige? • Framework not prescriptive • All inclusive • Focus on common requirements • Adaptable • Leading edge of management practices 10/23/2021 Dickson Consulting 6

Self-Assessment • Identify boundaries of the organization • Select champions for business categories • Decide on format and scope • Prepare organizational profile • Practice self assessment techniques 10/23/2021 Dickson Consulting 7

Self-Assessment-Continued • Select business category teams • Share responses/finalize findings • Prioritize key strengths/opportunities for improvement • Develop and implement an action plan for improvement • Evaluate and improve your self-assessment and action process 10/23/2021 Dickson Consulting 8

Integration of the Baldrige Criteria • Integrated strategy -Cross functional approach -One long-term strategy • Integrate with: -Medical device regulatory requirements -Performance management system -Sarbanes Oxley -Toyota Production System concepts -Six Sigma -Economic value added (EVA) -ISO -Benchmarking 10/23/2021 Dickson Consulting 9

Dickson Consulting Presentations Available • Critical Success Factors for a Medical Device Company • Listing on the London Stock Exchange AIM Market • Overview of the Stark Laws • Medical Device Industry Updates - June 23, 2006 - June 30, 2006 - July 7, 2006 - July 14, 2006 10/23/2021 Dickson Consulting 10

Services of Dickson Consulting (With a Focus on Medical Device Companies) • Board of Directors representation – Designated financial expert • CEO/COO/CFO services • Strategic planning facilitation • Financing assistance • Exit strategy and M&A assistance • Other special projects 10/23/2021 Dickson Consulting 11

Disclaimers • This report is not intended to provide investment advice or any other advice on any company mentioned. • The information in this report is believed to be correct but no assurances are provided that the information is correct. • Events may have occurred that are significant that are not mentioned in this report. 10/23/2021 Dickson Consulting 12