2: PART I- Foundations

Introduction

The SMDC case study is the backbone of this practicum. Every milestone, decision, and design conversation takes place within its context. Understanding SMDC not just as a project—but as a living, evolving organization with constraints, stakeholders, and ambitions—is essential for meaningful engagement with the risk work ahead.

In this chapter, we take a narrative and systems-level view of SMDC: who they are, what they’re building, what forces shape their world, and why risk management is not just important—but defining.

1. The Founding Problem: Self-Managed Diabetes is a Data Burden

Diabetes is a chronic condition. But unlike most chronic conditions, diabetes is largely managed not by clinicians—but by patients themselves. Every day, people with Type 1 and Type 2 diabetes make dozens of data-informed decisions:

• When and what to eat

• When and how much insulin to administer

• How to interpret glucose fluctuations

• When to seek help or adjust routines

Yet the data tools available to them are fragmented, technical, or emotionally confusing. Real-time Continuous Glucose Monitor (CGM) data lives in one app. Fitness data in another. Meal logs in a third. Advice from clinicians might arrive by text, email, or not at all.

This is the gap SMDC (Self-Managed Diabetic Care Inc.) was formed to address.

2. The SMDC Vision

SMDC is a health technology startup with a mission to:

“Translate complex diabetes data into simple, actionable insight that builds trust, safety, and independence.”

Their goal is to design a patient-facing dashboard that:

• Consolidates device data

• Visualizes blood glucose trends and alerts

• Offers behavior prompts that support self-care

• Enables secure data-sharing with clinicians

• Respects patients’ autonomy, privacy, and emotional experience

This is not just a product—it’s a personal assistant, risk interpreter, and decision partner for people managing one of the world’s most data-dependent conditions.

3. Timeline, Funding, and Product Scope

As the course begins, SMDC is six months into its startup life. It has:

• A small seed funding round (enough to build an MVP)

• A multidisciplinary founding team (tech, product, and clinical advisory)

• A commitment to pilot with early user groups in three months

• A narrow MVP scope with high expectations

The team is under pressure to:

• Deliver a demo-ready product within a fixed sprint calendar

• Balance speed and clinical credibility

• Meet HIPAA compliance

• Establish internal process and culture from scratch

Startup risk is baked into every aspect of the SMDC timeline. There is no buffer. Every decision, control, and breakdown has consequence.

4. Key Stakeholders and Their Tensions

SMDC is a system of humans. The risks and decisions in this book live in the tensions between stakeholders:

5. Why Risk Thinking Matters at SMDC

SMDC operates in the real world, with real stakes. Risks at SMDC are:

• Technical (system downtime, data mismatch, alert failure)

• Clinical (dangerous recommendations, misread trends)

• Emotional (patient overwhelm, clinician distrust)

• Cultural (inequity, exclusion, usability assumptions)

• Legal (HIPAA, FDA oversight, audit trails)

• Strategic (burnout, funding gaps, unclear handoffs)

Risk cannot be owned by one team or avoided through perfection. It must be surfaced, structured, and shared.

In this practicum, you will step into the SMDC team as a risk strategist and analyst, embedded in their journey. Your work will not be theoretical—it will reflect the real choices that early-stage teams must make under pressure, ambiguity, and mission-driven urgency.

6. A Final Word Before You Begin

Remember: you are not just evaluating someone else’s project. You are stepping into a living system—with data, tension, emotion, and tradeoffs.

You are here to help a team manage risk—not just protect the product, but protect the people it’s designed to serve.

Now turn the page—and step into SMDC.