10 Most Trusted Healthcare Consulting Firms (2)

1. Health Everything June Issue : 01 2023 ar re Transforming Healthcare www.healthcareeverything.com Pa?ent-Centric Approach The Role of Healthcare Consul?ng Success Strategies Digital Advancements Transforming Healthcare Industry 10 Trusted Healthcare Firms Ash Shehata Na?onal Healthcare and Life Sciences Leader KPMG US Leading Healthcare Towards a Reimagined Future

2. Be?er Health and a better way of life.

4. Editor’s Note

5. The Role of Healthcare Consulting Firms A Catalyst for Industry Transformation I industry transformation, driving positive change and innovation. With their expertise, knowledge and strategic guidance, healthcare consulting firms play a pivotal role in shaping the future of healthcare. Furthermore, healthcare consulting firms are crucial in facilitating technological advancements in the healthcare industry. With the rapid growth of digital health solutions, such as telemedicine, electronic health records and artificial intelligence, these firms assist healthcare organizations in navigating the complexities of technology implementation. They guide selecting the right systems, ensuring data security and privacy, and maximizing the benefits of digital tools for both patients and providers. n today's rapidly evolving healthcare landscape, the role of healthcare consulting firms has become increasingly vital. These firms serve as catalysts for Healthcare consulting firms bring together diverse professionals, including clinicians, researchers, data scientists and business experts, to tackle the industry’s complex challenges. They provide valuable insights and tailored solutions to hospitals, healthcare systems, pharmaceutical companies and other healthcare organizations. Their experience spans a wide range of areas, from operational efficiency and financial management to digital transformation and patient experience enhancement. In an era of healthcare reform and shifting regulatory landscapes, healthcare consulting firms are essential partners for organizations seeking to adapt and thrive. They stay up-to-date with industry trends, regulatory changes and best practices, enabling them to offer strategic guidance and help organizations navigate complex compliance requirements. Healthcare Everything’s latest edition “10 Most Trusted Healthcare Consulting Firms” have shortlisted a few healthcare consulting firms that are pivotal in driving positive change and innovation within the healthcare industry. Their expertise, strategic guidance and innovative solutions are invaluable for healthcare organizations striving to deliver high-quality care while navigating the complexities of a rapidly evolving landscape. One of the primary benefits of engaging healthcare consulting firms is their ability to identify inefficiencies within healthcare systems. Rigorous analysis and benchmarking help organizations optimize their processes, reduce costs and improve patient outcomes. By leveraging their extensive knowledge and experience, these firms help healthcare providers cost-effectively deliver high-quality care. Pja Sh -Pooja Shah

6. 20 28 MDI Consultants Assisting Medical Device Companies Achieve Regulatory & Standard Compliance with the U.S., European and Canadians Agencies Candesic Alliance of Business and Health Care Expert Consultants Contents 24 16 Article Patient-Centric Approach Success Strategies Digital Advancements Transforming the Healthcare Industry The Role of Healthcare Consulting

7. Cover Story 08 KPMG US Leading Healthcare Towards a Reimagined Future

8. Chidiebere Moses Ogbodo Editor-in-Chief Pooja Shah Saloni Agrawal Managing Editor Executive Editor Visualiser David King Mrunalinee Deshmukh Art & Design Head Co-designer Paul Belin Deepanjali Jena Art & Picture Editor Business Development Manager Marketing Manager Eric Jackson Carol Wilson James Vincent, Brian Cooper Nick, Elisha and Mary Business Development Executives Sales Executives Technical Head Jacob Smith Prashanth Hiremath Assistant Technical Head Technical Consultants David, Robert Alina Sege Nikita Khadalkar Digital Marketing Manager Assistant Digital Marketing Manager SME-SMO Executives Gemson Research Analyst Carl Vincent Circulation Manager Tanaji Fartade sales@healthcareeverything.com June, 2023 Contact Us: Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - 614-602-4132 Email: info@healthcareeverything.com For Subscription: www.healthcareeverything.com Insights Success Media and Technology Pvt. Ltd. Survey No.133/134, Brand Square, Office No. 512, Kunjir Chowk, Pimple Saudagar, Pune, Maharashtra 411027. Phone - India: 7410033802, 8956487823 Email: info@healthcareeverything.com For Subscription: www.healthcareeverything.com Follow us on : www.facebook.com/Healthcareeverything/ https://twitter.com/healthcareeverything We are also available on : Copyright © 2023 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Healthcare Everything is powered by Insights Success Media and Technology Pvt. Ltd.

9. 10 Most Trusted Healthcare Consul?ng Firms Company Featuring Brief Companies, investors and government entities around the world turn to Alvarez & Marsal (A&M) when conventional approaches are not enough to drive change and achieve results Alvarez & Marsal alvarezandmarsal.com Tom Elsenbrook MD Boston Consulting Group is a global consulting firm that partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. Boston Christoph Schweizer CEO Consulting Group bcg.com Candesic provides management consultancy and commercial due diligence services to corporates, private equity and other financial investors, and public sector organisations like the NHS. Dr Michelle Tempest Managing Partner Candesic candesic.com Family Business Solutions familybusinesssolutions.co.uk Billy Andrew Management Consultant For over 20 years, Family Business Solutions Ltd (FBS) has been providing support to owner managed and family businesses. HealthCare Law is a law firm specifically designed around healthcare clients founded in 2015 by Hugo Barton, who is the managing director and solicitor. Hugo Barton CEO HealthCare Law healthcarelaw.co.uk Ash Shehata Naonal Healthcare and Life Sciences Leader KPMG US is one of the world’s leading professional services firms and the fastest growing Big Four accounting firm in the United States. KPMG US kpmg.com L.E.K. Consulting is a global management consulting firm that uses deep industry expertise and rigorous analysis to help business leaders achieve practical results with real impact. Jonas Funk Managing Director L.E.K. Consulting lek.com MDI Consultants is a leader in providing consulting services to the healthcare industry worldwide. Alan Schwartz Executive VP MDI Consultants mdiconsultants.com Russell Reynolds Associates help its clients build teams of transformational leaders who can meet today’s challenges and anticipate the digital, economic and political trends that are reshaping the global business environment. Russell Reynolds Associates russellreynolds.com Clarke Murphy CEO Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Michelle Keefe CEO Syneos Health syneoshealth.com

11. KPMG US Leading Healthcare Towards a Reimagined Future Healthcare is a higher-purpose industry offering leading technology, financial planning, M&A, opera?onal effec?veness, risk management, regulatory compliance, tax, and audit capabili?es. I think this is a once-in-a- genera?on type of opportunity to help healthcare organiza?ons transform and offer the right care, at the right ?me, in the right way and in a more personalized, customized and cost-effec?ve manner.

12. Ash Shehata Na?onal Healthcare and Life Sciences Leader KPMG US

13. 10 Most Trusted Healthcare Consul?ng Firms he healthcare sector has been undergoing extensive T patient-centric model. In the coming two decades, every aspect of healthcare will be digitally transformed—from patient experience to clinical operations, along with the necessary skills required to enable operating in a future- enabled healthcare environment. healthcare organizations to create a seamless connection and meet future outcomes efficiently. transformation to keep up the pace and meet modern expectations with a paradigm shift towards a Below are the highlights of the interview. Kindly brief us about KPMG Healthcare in the US. KPMG helps organizations across the healthcare and life sciences ecosystem to work together in new ways to transform and innovate the industry. With that said, healthcare leaders are compelled to ensure that the care delivery system is compliant with the direction of the future. They also check whether their services and operations are in alignment to support the healthcare service providers to tackle challenges and transform the way healthcare is delivered around the globe. We offer a market-leading portfolio of services focused on embedding data science and digital technologies throughout the business—to enable patient-centric approaches and personalization, drive greater business portfolio segmentation to enable wide-scale customer centricity, enable enhanced connectivity and performance transparency within business portfolios from front to middle to back office, manage risk and comply with regulations, and create strategic, differentiated pricing to succeed in a world of personalized healthcare solutions. The primary goal of digital transformation in the healthcare industry is streamlining processes, harnessing data, or shaping entirely new ways of doing business, with a clear aim of uniting every part of the enterprise for an efficient day-to-day service delivery. This helps to optimize major workflow processes and compliances, along with managing patient health with cost-effective solutions. What inspired you to venture into the healthcare sector? I grew up in a family with several of our family members who were already in the medical field. This enabled me to experience first-hand the positive impact that can be made, Currently, clinics and hospitals have data coming in from varied sources such as electronic health records, lab results, insurance claims, medical devices, imaging, and more. With all of these sources, it’s possible to overlook important patient medical history data. Data aggregation tools such as KPMG Aggregation and Reporting Tool (KART) enables fast and informed patient-care decisions without having to worry about missing key information. KPMG is a Big Four firm aligning resources across audit, tax and advisory. Its key services in Healthcare and Life Sciences span across these func?ons. We con?nue to make organic and inorganic investments to stay ahead of the fast- paced, innova?ve market and help our clients with leading prac?ces. KPMG US is a company that envisions the possibility of healthcare transformation by offering a market-leading portfolio of services focused on embedding data science and digital technologies that helps its clients to achieve their desired goals. Equipped with leading strategies and blueprints for designing and executing better service delivery—to make sense of the volume of technological change, absorb and deliver the vast information available to health leaders in an easy-to-use way. As a leading provider of risk, financial and business advisory, tax and regulatory services, internal audit, and corporate governance, KPMG aims for a business world that is propelled by insights, transparency, innovation and excellence. In an interview with Insights Care, Ash Shehata, the National Healthcare and Life Sciences Leader,explains how KPMG US is a suitable support factor in enabling

14. Ÿ Courage: We think and act boldly. Ÿ Together: We respect each other and draw strength from our differences. Ÿ For Better: We do what matters. What are the core products and services that your company has to offer? In what way do they serve the target population? How are these different from other forms of assistance that healthcare clients receive? We offer services across consulting, risk management, regulatory compliance, transactions, tax and audit. We often work with alliance partners to solve some of our clients’ most complex business challenges across the front, middle and back offices of the enterprise. We create unique IP through our Lighthouse signals repository as well as our Ignition Centers, and Innovation Labs. We work shoulder- to-shoulder with our clients and operate as trusted advisors committed to their success. and that healthcare is a higher-purpose industry. I then pursued my master’s and did my research thesis on health equity before it was headline news, as I truly believe that Healthcare access should be universal. I started my career at the University of Cincinnati Medical Center, and after various industry and technology roles, I came to KPMG. What is your opinion are the areas that the healthcare clients need the most help or support with? How does your company offer personalized solutions to them? KPMG is a Big Four firm aligning resources across audit, tax and advisory. Its key services in Healthcare and Life Sciences span across these functions. We continue to make organic and inorganic investments to stay ahead of the fast- paced, innovative market and help our clients with leading practices. Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company? I’ve touched upon the fact that healthcare is a higher- purpose industry, and that is what inspires me to lead this sector at KPMG. It’s energizing for me and our teams to come to work each day with that underlying sense of purpose and fulfillment. Having a vision on how organiza?ons need to transform across the front, middle and back office with Powered, Connected and Trusted methodologies is what drives us forward. Healthcare comprises a fifth of the U.S. GDP. Thus, we have an opportunity to help healthcare organizations transform to provide greater healthcare access, leverage innovation, technology and data insights to drive greater efficiencies and deliver an overall better patient and member experience. Can you elaborate upon the core values, mission and vision on which KPMG US is built? We recently celebrated 125 years as a Big Four firm with a strong brand, commitment to excellence, and subscribing to and living out our values daily, which are: Ÿ Integrity: We do what is right. Ÿ Excellence: We never stop learning and improving.

16. KPMG US is awarded and iden?fied as a leader across many key analysts’ reports that affect clients’ most pressing business challenges. Below are some of these: Ÿ Leader in Asia Pacific Professional Security Services 2022 Vendor Assessment Ÿ Leader in Canadian AI Services 2022 Vendor Assessment Ÿ Ranked number one among risk advisory firms by clients Ÿ Named as M&A Innovator in ALM Intelligence Pacese?er Research Ÿ Named a Pacese?er Leader in Cyber Security in ALM Intelligence Pacese?er Research What operations and procedures does the company find to be essential when supporting healthcare clients? type of opportunity to help healthcare organizations transform and offer the right care at the right time, in the right way, and in a more personalized, customized and cost- effective manner. Having a vision of how organizations need to transform across the front, middle and back offices with Powered, Connected and Trusted methodologies is what drives us forward. We also leverage Global and various CEOs such as Advisory Insights, Corporate Assets, Ignition, Insights Centers, and Innovation Labs. How do you envision scaling your company’s services and operations in 2023 and beyond? We established KPMG Lakehouse, representing an investment in our most valuable asset and the biggest point of pride, i.e., our people. KPMG Lakehouse is a purpose- built, state-of-the-art learning and innovation center, reflecting our rich 125-year history while bringing in new diversity of thought, perspectives, and backgrounds with each learner who comes through the doors. What endeavours is KPMG US currently pursuing to improve its measures and best serve your clients? We leverage programs such as Exceptional Audit and Voice of the Customer, industry analyst recognition, thought leadership, industry symposiums, national conferences, membership affiliations, and KPMG Lakehouse. We have Ignition Centers with specialized teams that think and work differently to produce results for our clients. Ignition helps clients see beyond the now, sensing opportunities and possibilities for newer, faster, and better outcomes for their business. We also have Innovation labs that provide insights on signals of change so that clients can understand and plan for what's coming around the corner. What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into healthcare consulting? Healthcare is a higher-purpose industry offering leading technology, financial planning, M&A, operational effectiveness, risk management, regulatory compliance, tax, and audit capabilities. I think this is a once-in-a-generation

18. Patient-Centric Approach 16 The Role of Healthcare Healthcare Healthcare Consulting June 2023 www.healthcareeverything.com

19. 17 I n today's rapidly evolving healthcare landscape, providing high-quality care and improving patient outcomes are paramount. This shift in focus has led to adopting a patient-centric approach, which places patients at the center of healthcare delivery and decision-making processes. Healthcare consulting firms are crucial in facilitating this transformation by guiding healthcare organizations in implementing patient-centric strategies and practices. preferences of each individual patient. It emphasizes active patient involvement in decision-making, personalized care plans, and enhanced communication between patients and healthcare providers. This approach recognizes that patients are not mere recipients of healthcare services but active participants in their own care journeys. Strategic Guidance for Healthcare Organizations Healthcare consulting firms provide strategic guidance to healthcare organizations to help them adopt and implement patient-centric practices. They conduct comprehensive assessments of existing systems and processes, identifying areas for improvement and developing tailored strategies that prioritize patient satisfaction and engagement. By understanding the unique needs of the organization, consulting firms can offer customized solutions that align with the organization's mission, values, and goals. In this article, we will explore the role of healthcare consulting in promoting a patient-centric approach and its impact on the overall healthcare experience. Understanding the Patient-Centric Approach The patient-centric approach revolves around the idea that healthcare should be tailored to meet the unique needs and June 2023 www.healthcareeverything.com

20. Implementing Patient-Centric Technologies satisfaction surveys, analyzing the results and identifying areas for improvement. In the digital age, the technologies plays a vital role in facilitating patient-centric care. Healthcare consulting firms assist organizations in identifying and implementing appropriate technologies that enhance patient experiences. These technologies include electronic health records (EHRs), patient portals, telemedicine platforms, and mobile health applications. Consultants collaborate with healthcare organizations to develop comprehensive survey instruments that capture patient experiences across various touchpoints, such as access to care, communication with healthcare providers, care coordination, and overall satisfaction. They help organizations analyze the survey data and identify trends and patterns that can inform quality improvement initiatives. EHR systems allow healthcare providers to have a comprehensive view of a patient's medical history, ensuring continuity of care across different settings. Patient portals enable patients to access their health information, schedule appointments, communicate with healthcare providers, and actively engage in their care. Telemedicine platforms provide convenient access to healthcare services, particularly for individuals in remote or underserved areas. Mobile health applications empower patients to track their health metrics, receive personalized health education, and manage their conditions effectively. The Impact of a Patient-Centric Approach Adopting a patient-centric approach has numerous benefits for both patients and healthcare organizations. Patients experience improved satisfaction, increased engagement, and better health outcomes. When patients feel that their needs and preferences are acknowledged, and they are actively involved in their care decisions, they are becoming more invested in their own health. This leads to greater adherence to treatment plans, increased self-management of chronic conditions, and ultimately, better health outcomes. Enhancing Communication and Engagement 18 Effective communication is a cornerstone of patient-centric care. Healthcare consulting firms work closely with healthcare organizations to develop strategies that foster clear and open communication channels between patients and providers. This includes improving the informed consent process, ensuring effective patient education, and implementing shared decision-making frameworks. Additionally, patient-centered care reduces medical errors and enhances care coordination. By fostering open communication channels, healthcare organizations can identify and address potential risks and gaps in care more effectively. This leads to improved patient safety, reduced healthcare costs associated with preventable errors, and better coordination of services across different providers and settings. Consultants help healthcare providers refine their communication skills to ensure empathetic and effective interactions with patients. This involves active listening, addressing patient concerns, and using plain language to explain medical information. Consultants may also facilitate communication workshops or training sessions to enhance the organization's overall communication culture. Conclusion In conclusion, healthcare consulting firms play a pivotal role in promoting a patient-centric approach within the healthcare industry. By placing patients at the center of healthcare, organizations can improve patient experiences, enhance care outcomes, and thrive in an evolving healthcare landscape. The patient-centric approach is not just a trend but a fundamental shift that prioritizes individual needs, preferences, and empowerment. With the support of healthcare consulting, organizations can truly transform their practices and create a healthcare system that revolves around the well-being and satisfaction of patients. Measuring and Improving Patient Satisfaction Healthcare consulting firms recognize the importance of measuring patient satisfaction as a key metric for evaluating the success of patient-centric initiatives. They assist organizations in designing and implementing patient June 2023 www.healthcareeverything.com

22. 10 Most Trusted Healthcare Consul?ng Firms Candesic Alliance of Business and Health Care Expert Consultants W over a period of time. Organizations in the industry are preparing for the next generation of health care services. e have reached the time when the health care industry has one of the top growths. The work, the technology, and the requirement expanded Healthcare consultants ease the work for healthcare organizations. They do other management work— such as HR, marketing, B2B contracts, people management, and legal affairs—which is required to grow as well as to keep the hierarchy of healthcare organizations running. These consultants have the relevant education and background on healthcare laws, regulations, and policies. There are many challenges faced by the health organizations such as shortage of labour, changes in rules, and customer change in behaviour. On top of that, the pandemic drove the healthcare industry to its lowest state where the number of patients was more than what the healthcare infrastructure could accommodate. Even precautions of healthcare workers are a priority. 20 Candesic, London-based leading strategy consultancy with over 30 consultants and 150 experts, serving private operators, investors, and public sector organizations. Speaking of giving advice and consultancy, we recently took an interview of an expert healthcare consultant who worked in the industry for more than 18 years, Dr Michelle Tempest, Managing Partner, Candesic. Read the following interview to gain insights into the healthcare consultancy space and how Dr Tempest is making an impact in it. With looking out for daily changes in the industry, healthcare organizations have a lot of things to keep track of, and alongside they have to look out for the health of their patients and the success of the organization. Please brief our audience about Candesic, its values, and the key aspects of its stronghold within the healthcare consulting industry. We enjoy working with clients who share our passion for "improving lives". Candesic was founded 20 years ago by business consultants and medical professionals to bring unmatched sector expertise to help solve complex issues. We are unique in this field as an ethically driven outcome-focused sustainable healthcare consultancy – our purpose is to help our clients make health and care accessible and equitable for all. Today, our team consists of more than 30 full-time consultants and over 150 experts. We bring cultural and cognitive diversity to our company unmatched by our peers. June 2023 www.healthcareeverything.com

23. Dr Michelle Tempest Managing Partner, Candesic About the Leader 21 Dr Michelle Tempest was originally a front- line medical doctor and worked for over a decade in acute hospitals. She moved into healthcare consulting with a passion to integrate care across hospital, community, and home care and develop more joined-up services. As a strategy consultant, she works across life sciences, healthcare, social care and the digital, tech, device sectors. She has written a book about AI (The Big Brain Revolution: Artificial Intelligence – Spy or Saviour) and invests in digital start-ups. She enjoys working at the cutting edge of science to help democratize research into real- world health innovations. June 2023 www.healthcareeverything.com

24. Candesic fared during the pandemic and subsequent lockdowns? The level of interest to invest in healthcare sky-rocketed during the pandemic. The world saw the impact of being vaccinated and it's been a joy to watch populations embrace research and development. From Candesic's perspective, we have been busy delivering project work – true to our core values of 'CEO level clarity, R&D level analysis' and ensuring high-quality care is available to all. Our decades of deep sector knowledge mean that we can add measurable value, to improve patient care and deliver return on investment for clients. Can desic advises global policymak ers, NHS, investors (PE and VC), private operators, public hospitals, charities, medical technology, healthcare IT, start-ups and life sciences/ pharmaceutical companies on topics covering healthcare strategy, global expansion and investment. By serving a wide range of clients, we use our expertise to influence every stakeholder involved in integrated care. We are proud to have supported investors and operators to innovate, question the status quo and deliver improved health outcomes with clinical rigour. We enjoy working with clients who share our passion for "improving lives". Tell us more about the services that make Candesic stand out from the competition? In your opinion, what could be the future of the healthcare consulting services sector post the pandemic? And how are you strategizing Candesic's operations for that future? Healthcare consulting, I hope, will become even more data-driven. The internet of things and the consumerization of healthcare allows for large data sets and patterns to be spotted. I'm excited to tie consulting to patient-level impact together, on a global scale. 22 As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the healthcare consulting services sector? Health and care are a lifetime of dedication. Budding entrepreneurs are all welcome to bring a multi-disciplinary approach and new business ideas to complex problems. But it's not a quick-buck sector and companies must have evidence-based before they have the right to expand. How do you envision scaling Candesic's operations in 2022? Candesic's beating heart is the amazing team who work here. We are growing globally alongside bringing a human heart to big data projects. When you work across life sciences, health and care it's vital to link how innovation and change can improve patient outcomes. I'm proud every day to work in a multidisciplinary, diverse and multilingual environment and see our work impact personalised healthcare. Our projects depend on rigour, rapid turnaround time, large data analysis, intensive primary research and the ability to be a trusted advisor. We combine this with true sector expertise and deep-rooted healthcare and academic knowledge. Our consultants and experts work together with our clients – both investors and corporates – and collectively find solutions. What is your opinion on the impact of the current pandemic on the global healthcare sector, and how has June 2023 www.healthcareeverything.com

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27. Advancements Industry I us ry M transformation driven by digital advancements. The integration of technology has revolutionized various aspects of healthcare, including patient care, diagnostics, treatment, and administrative processes. These digital advancements have the potential to improve efficiency, enhance patient outcomes, and empower healthcare providers. with healthcare providers virtually, eliminating the barriers of distance and enhancing access to care, particularly for individuals in rural or underserved areas. Healthcare organizations can embrace telemedicine by implementing secure video conferencing platforms, ensuring regulatory compliance and integrating telemedicine services into their existing workflows. Success in telemedicine implementation requires a strong technological infrastructure, clear communication with patients, and training for healthcare providers to deliver effective virtual care. edical industry is experiencing a significant 25 Artificial Intelligence (AI): Enhancing Diagnosis and Treatment In this article, we will explore the key digital advancements that are transforming the healthcare industry and discuss success strategies for organizations to navigate this digital revolution. AI has emerged as a strong tool in healthcare, transforming the way diagnoses are made and treatments are delivered. Machine learning algorithms analyzes large amounts of medical data to identify patterns, detect diseases, and provide personalized treatment recommendations. Success in leveraging AI requires healthcare organizations to invest in robust data management systems, ensure data privacy and security, and collaborate with AI experts to develop accurate and reliable algorithms. By integrating AI into clinical workflows, healthcare providers can enhance diagnostic accuracy, improve treatment outcomes, and optimize resource utilization. Telemedicine: Expanding Access to Care One of the most significant digital advancements in healthcare is the rise of telemedicine. Telemedicine involves the use of communications technology to provide remote healthcare services. It enables patients to connect June 2023 www.healthcareeverything.com

28. Internet of Things (IoT): Connected Healthcare Ecosystems Cybersecurity: Safeguarding Patient Data As digital advancements continue to transform the healthcare industry, cybersecurity has become a critical concern. The increased reliance on digital systems and the sharing of sensitive patient data make healthcare organizations vulnerable to cyber threats. Success in cybersecurity requires healthcare organizations to implement robust security protocols, educate staff on cybersecurity best practices, and continuously monitor and update security measures. By prioritizing cybersecurity, healthcare organizations can protect patient data, maintain trust, and prevent potential breaches that may adversely affect patient care and organizational reputation. The Internet of Things (IoT) has enabled the development of connected healthcare ecosystems, where medical devices, wearables, and other healthcare technologies are interconnected and seamlessly share data. Success in leveraging IoT requires healthcare organizations to implement interoperable systems, ensure data integrity and security, and establish clear protocols for data collection and analysis. By harnessing the power of IoT, healthcare providers can gain valuable insights into patient health, enable remote monitoring, and deliver proactive and personalized care. Electronic Health Records (EHRs): Streamlining Information Management Collaboration and Partnerships: Navigating the Digital Transformation The adoption of electronic health records has transformed information management in healthcare. EHRs digitize patient medical records, making them easily accessible to healthcare providers across different care settings. Success in implementing EHRs requires healthcare organizations to invest in user-friendly EHR systems, ensure interoperability with other healthcare systems, and provide comprehensive training for healthcare providers. By leveraging EHRs, healthcare organizations can streamline workflows, reduce medical errors, improve care coordination, and enhance patient safety. Navigating the digital transformation in healthcare requires collaboration and partnerships among healthcare organizations, technology companies, and regulatory bodies. Success in the digital era necessitates embracing a culture of innovation, fostering interdisciplinary collaborations, and staying informed about emerging technologies and industry trends. Healthcare organizations should actively seek partnerships with technology companies to leverage their expertise and drive innovation in the field. Collaboration with regulatory bodies is crucial to ensure compliance with evolving digital health regulations and to establish standards for data privacy and security. 26 Data Analytics: Driving Evidence-Based Decision Making Conclusion Data analytics plays a key role in healthcare industry by enabling evidence-based decision-making. Advanced analytics tools can analyze vast amounts of healthcare data to identify trends, patterns, and correlations that inform clinical decision-making, resource allocation, and quality improvement initiatives. Success in data analytics requires healthcare organizations to establish robust data governance frameworks, invest in analytics infrastructure, and ensure compliance with privacy and security regulations. By harnessing the power of data analytics, healthcare organizations can improve patient outcomes, optimize resource utilization, and drive continuous quality improvement. Digital advancements are revolutionizing the healthcare industry, offering unprecedented opportunities to improve patient care, enhance outcomes, and streamline processes. Success in leveraging these technologies requires healthcare organizations to invest in robust technological infrastructure, establish clear protocols and standards, and foster a culture of innovation and collaboration. By embracing the digital transformation, healthcare organizations can navigate the changing landscape, deliver patient-centered care, and drive positive change in the industry. The future of healthcare is digital, and organizations that embrace these advancements will thrive in delivering efficient, effective and patient-centric care. June 2023 www.healthcareeverything.com

30. 10 Most Trusted Healthcare Consulting Firms Assisting Medical Device Companies Achieve Regulatory & Standard Compliance with the U.S., European and Canadians Agencies or new medical companies, it can be daunting to put F how to deal with it. mdi Consultants, a leading provider of FDA consulting, quality assurance, regulatory compliance and clinical services—offers services that are focused on assisting medical device, pharmaceutical and food companies across the globe. It is committed to helping its clients achieve regulatory and standard compliance with U.S., European and Canadian agencies and organizations. someone to come to their aid and provide the necessary expertise to get into compliance and have someone to represent their regulatory needs. up with FDA visits and longer inspection runs. They not only have to put up with it but often are unsure Shed some light on your journey as the guiding light of the company. How does your presence play an important role in the growth of the company? Learning to be in business took several years, and going through several partners. No funding, no salary, no clients, what a start. I read a book, the Outlier, by Malcolm Gladwell and he said it takes 10,000 hours to become an The company's approach to client service is to provide its clients with expert consultants who are armed with a proven and flexible consulting methodology. In an interview with Insights Care, Alan Schwartz, the ExecutiveVP, shares in depth about the company's approach to providing its clients with a customized service that meets their specific needs. 28 We always look to provide our clients the assistance they need to get them to reach their goals. We pride ourselves on giving our clients the most advantageous way of dealing with the FDA. At times there are several options. One option would cost the client more money and have them reach their goal. The other one is a little more creative and would save a ton of money and time. We look to do that for our clients many times with success that no other regulatory consultant or attorney could come up with. Following are the excerpts from the interview: Kindly brief us about the company. What inspired you to venture into the healthcare sector? After coming out of college, I took a job with the USFDA. I was a field investigator going into companies and making sure that they were in compliance with the FDA regulations. That was in 1972. In 1976, the US Congress came out with the regulate the medical device industry. I left the FDA in 1978, after reaching the level of Supervisor of field operations. The medical device industry was in its infancy, made up of many small companies and start-ups that had no idea how to deal with the FDA regulations. When I was with the FDA, I saw how small companies had a hard time understanding the FDA regulations, let alone how to deal with the agency. I felt that these small companies needed June 2023 www.healthcareeverything.com

31. 29 Alan Schwartz Executive VP MDI consultants expert. Well, it took five years of keeping the focus on developing a strong business following and building a strong client list. We took a different path than most consultants who look to have one project after another. The business is like a sine wave, hoping that the frequency between projects is short and that the altitude of the next project is higher than the previous one. operations. This reduced the risk of the sine wave business problems. Also, allowed us to grow with new employees as needed. This business plan had worked well when compared to many other consultants that I had met over the years in business. They had some great years and some very lean ones. mdi had very few problem years and many years of nice level growth. This is a very hard road to take. We looked to get most of our clients on a long-term retainer and this way to keep the cash flow coming in to cover the expenses of the As for having partners, or employees, I always wanted to work with a team. As you can see, we didn't name the consulting company after my name, Alan Schwartz June 2023 www.healthcareeverything.com

32. Associates or such, as you find many other consultants have done. The reason for this is that I never wants clients to hire me but I wanted them to seek our company. Having partners and/or employees also allowed me to get away from time to time and still have the company running. Can you elaborate upon the core values, mission, and vision on which the company is built? assist with responding to the FDA 483 List of Observations left by the FDA investigator after their inspection. This can be critical to avoid additional regulatory actions. mdi has been able to avoid warning letters to be issued as well as address the FDA's concerns and negotiated issues with the Agency on behalf of the company. We have worked with companies worldwide on FDA inspections, and FDA submissions. What operations and procedures does the company finds to be essential when supporting healthcare clients? We always look to provide our clients with the assistance they need to get them to reach their goals. We pride ourselves in giving our clients the most advantageous way of dealing with the FDA. At times there are several options. One option would definitely cost the client more money and have them reach their goal. The other one is a little more creative and would save a ton of money and time. We look to do that for our clients many times with success that no other regulatory consultant or attorney could come up with. We have been determined to provide our client companies with personalized services. We learned that our clients want to receive returned calls and/or emails. We have maintained long-term relationships with our clients. Some clients have been using mdi for over 40 years. We are proud of this long-term relationship. We feel we are like an insurance policy, we are there when it is needed. What are the core products and services that your company has to offer? In what way do they serve the target population? How are these different from other forms of services that healthcare clients receive? What endeavors is the organization currently pursuing to improve its measures and best serve your clients? We constantly review what our clients need to be competitive and in compliance. We have added our US Agent services to our foreign clients. We provide Health Canada licensing for medical devices for marketing in Canada. We also assist our clients in preparing their Technical Files under the Medical Device Directive for marketing under the CE mark. 30 mdi has been providing FDA regulatory consulting services since 1978. We provide a very important service to smaller companies and start-ups, regulatory strategies. Many entrepreneurs know their device and maybe the market but have very little experience in navigating the FDA regulatory process, which could be the main obstacle to entering the marketplace. Most smaller and new companies have no idea of what it would take to get their device through the FDA review process. That is where mdi comes in to provide this guidance and understanding. mdi is also a consultant to mid and large companies to provide them with a second opinion and to provide the expertise that may be missing. What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into healthcare consulting? This is a journey, not a sprint. Marketing yourself is essential for a successful career. It takes a while to build a large client base. It is difficult to assure a continued flow of business. Be ready for a long hard ride. It took me over five years to make a yearly living that met my expectations. Another important service is assisting companies in dealing with the FDA inspection of their operations. This can be critical to a company's survival to pass an FDA inspection. mdi can provide pre-inspectional assistance to prepare for the audit, and be present during an inspection. We also June 2023 www.healthcareeverything.com

34. Helping one person might not change the world, but it could change the world for one person.

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