Are Managers Equipped to Lead a Digital Transformation?

by | Oct 22, 2021 | Analytics, Compliance, Consulting Group, Data, EU, EU MDR, EUA, FDA, Guidance, ISO, Medical Devices, MedTech, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


‌ 

Are Managers Equipped – in terms of skills, competencies and courage to lead a digital transformation? 

Digital Transformation requires strong managerial skills leadership.  They must also possess a strong understanding of their specific capabilities and how their organization uses information.  Pearlson, Saunders, & Galletta (2016) state that a manager in today’s world needs to understand these concepts with the same understanding of how to obtain and budget financial resources. 

Traditional business functions such as operations, accounting, finance, sales and marketing has become interwoven with information technology.  Information systems permeate into every aspect of a business, and therefore touches every employee in some form.  Strong managers realize this, and do not leave decisions regarding their company’s information technology solely to their IT departments.  Strong leaders also realize that a company’s informational needs may vary across the organizational chart and different levels of management may require different informational technologies (Pearlson, Saunders, & Galletta, 2016).  It is not the responsibility of the IT departments to make decisions on how and what technology their business needs. 

To address the question, “are managers equipped – in terms of skills, competencies and courage to lead a digital transformation”, my response would be it depends.  This is evident by the shear fact that some companies succeed and some fail.  Many of these failures can be traced back to poor decisions regarding digital transformations, while the opposite is true for successful companies.  The Information Systems Strategy Triangle (Pearlson, Saunders, & Galletta, 2016) provides a framework on the impact of information systems on businesses.  Just as important is a manager’s ability to lead their organization through ever changing informational systems across their business ecosystems.  A good model to reference is the Eras model (Pearlson, Saunders, & Galletta, 2016, p34) which, “summarizes the evolution of information resources over the past six decades”.  The leaders of today who have a firm understanding of these concepts will be successful in leading their organizations through the next era.

If your team needs support in your digital transformation to spark innovation and growth in your organization trust EMMA International’s in-house project management experts to implement your projects effectively, on time, and on budget.

Taking a white-glove approach, our project managers and consultants work alongside your team to create, develop, and/or improve your processes with long-term sustainability in mind. We guarantee your organizational goals are met — at no additional cost to you.

References:

Pearlson, K. E., Saunders, C. S., & Galletta, D. F. (2016). Managing and Using Information Systems A Strategic Approach 6th Edition. Hoboken, NJ: John Wiley & Sons

Kira Jabri

Kira Jabri

Kira Jabri, MPH, MSW, PMP is the COO of EMMA International Consulting Group, Inc. She is responsible for designing and implementing EMMA International’s business operations, marketing, and strategy. Mrs. Jabri has over twenty years of experience as a healthcare professional and is an industry expert in company culture and diversity, organizational behavior management, organizational leadership, business strategy development, and contemporary challenges in business. Mrs. Jabri holds a Master of Public Health from Walden University, a Master of Social Work from Columbia University and Bachelor of Arts degrees in Social Work and Psychology from Cedar Crest College.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This