Medical Devices Business Data Model: AI-Ready Edition

The Medical Devices Business Data Model: AI-Ready Edition is for CIOs, architects and transformation leads who need to know what information medical device work runs on before an AI agent touches it. It covers 18 subject areas, 105 entities, 732 key attributes and 358 relationships. Every entity and key attribute is classified for sensitivity, with the AI uses and data-quality requirements an agent depends on. It holds the 92 entities shared across healthcare and life sciences and the 13 specific to medical device companies, from Business Architecture for Healthcare and Life Sciences: AI Transformation Blueprint.

What's Inside

The same model comes in three files: the full model in Word, a workbook to filter and extend, and a guide to the scales and the license.

• 18 subject areas and 105 entities, each with a definition, its typical system of record, sensitivity class, AI uses and data-quality requirements
• 732 key attributes with sensitivity and AI relevance, and 358 relationships with cardinality
• Under each entity, the capabilities that need it and the agents that read it, by name and ID
• The Business Data Model (Word): every subject area and entity in full
• The workbook (Excel): subject areas, entities, attributes and relationships in sheets you can filter and extend
• The guide (Word): the scales the model refers to, the data foundation, and the license
• Free corrections, and new versions free for 180 days

Every file names your organization and carries your license ID.

The 18 Subject Areas

The 105 entities are grouped into 18 subject areas. The list gives what each holds and how many entities it has.

• People and Products in Care and Research (5 entities): The people who receive care or take part in studies, the clinicians and healthcare professionals the organization works with, and the medicines and medical devices it makes, uses or sells.
• Development Portfolio and Programs (4 entities): The development programs the organization runs, what each must achieve, the decisions taken on them and the nonclinical studies that support them.
• Clinical Studies (7 entities): Each clinical study the organization sponsors or hosts, its protocol and amendments, and what happens to each participant in it.
• Study Sites and Research Vendors (5 entities): The sites that run studies, the investigators who lead them there, the agreements and monitoring that govern them and the research organizations that run parts of a study.
• Clinical Data, Results and Data Use (6 entities): The data collected in studies, the results reported from them, the real-world data used for evidence, and the approvals for each use of patient and participant data.
• Regulatory Submissions and Authorizations (5 entities): What the organization submits to regulators, the authorizations it holds and the commitments it makes.
• Registration and Labeling (5 entities): Each product's registrations and their changes, the identifiers it carries, and the labeling that states what it is authorized for.
• Quality System and Audits (6 entities): The documents, training, audits, inspections and reviews that make up the quality management system.
• Quality Investigations, Change and Validation (4 entities): Investigations of departures from procedure, changes to validated items, and the validation that shows processes and systems work.
• Quality Control and Supplier Quality (6 entities): The samples, tests and stability studies behind product quality decisions, and the contract manufacturers, quality agreements and audits behind supplier quality.
• Regulated Production and Release (5 entities): How each product is made and recorded, the batches and lots produced, and the controls that keep them free of contamination.
• Distribution and Supply Continuity (5 entities): The serialized units and their movements, temperature excursions, clinical study supply and allocations when supply is short.
• Adverse Events and Safety Reporting (4 entities): Reports of harm or malfunction linked to a product, their assessment and the reports sent to regulators.
• Signals and Benefit-Risk (4 entities): Possible new risks found in safety data, the conclusions on each product's benefit and risk, and the measures and periodic reports that follow.
• Complaints and Recalls (4 entities): Complaints about products and their investigations, hazard evaluations and the field actions that follow.
• Medical Information and Healthcare Engagement (7 entities): Medical questions and answers, interactions and payments involving healthcare professionals, grants, and the material reviewed before use.
• Market Access, Accounts and Patient Support (10 entities): The evidence and contracts that secure access to products, the health system and distributor accounts, the rebates and chargebacks they create, and the programs that support patients.
• Device Design, Risk and Service (13 entities): Design inputs, outputs and reviews, the design history file and device history records, hazard analyses, software versions, and each device at a customer's site with its installation, service orders, service bulletins, field modifications and loaner sets.

Who Uses It

Data owners and stewards, data architects, and AI and analytics engineers who need to know what an agent may read, how sensitive it is and how good it must be first; and business architects who link capabilities to data.

How It Fits With the Other Products

The capabilities named under each entity are defined in the Healthcare and Life Sciences Capability Model: AI-Ready Edition. The agents are specified in Business Architecture for Healthcare and Life Sciences: AI Transformation Blueprint, which contains this data model and adds the value streams, use cases, controls, an operating model and a roadmap. The Medical Devices Value Streams are sold on their own too.