This course is a continuation of Medical Device Development. Topics cover the primary events that occur from just before “design freeze" of a medical device up through clinical evaluation and commercial launch. Significant emphasis is placed on Quality Systems and Manufacturing, with attention to regulatory and legal compliance as well as design concepts.
The course begins by supplementing already existing US Regulatory knowledge with the basics of medical device regulation in the EU. This discussion then carries on to post-design activities, such as finishing construction of the Design History File and the first steps of commercialization.
Once the device has entered to market, changes are often required to the manufacturing process and the device itself. Methods for enacting these changes and validating the resulting new processes are discussed.
Finally the course ends with a deep discussion on post-market activities in relation to Product Management and clinical trials. The necessary regulations for running human studies are covered in detail, along with a description of the Product Manager's role in making the activities come together.
First introduction and overview of the course. At the end, students will be able to:
* Gain an introduction to the course instructor
* Know who should and should not take this course
* Know what this course will cover
Discussion forum for Advanced MDD topics on the course introduction.
Description of some basic regulatory terms and concepts in the EU:
* Competent Authority
* Notified Body
* Authorized Representative
* CE Mark
Gain an understanding of the overall structure of the EU Government and how it proposes and adopts legislation. These rules, known as Directives, are then fulfilled by the member states.
Overview of the three different medical device directives:
93/42/EEC - Medical Device Directive (MDD)
98/79/EC - In vitro Diagnostic Directive (IVDD)
90/385/EEC - Active Implantable Medical Device Directive (AIMDD)
NOTE: Check back with this lecture in late 2015 to see changes for new EU directives to issue.
Description of content that goes into a Tech File and a Design Dossier. Outlines the structure of the files and how they are used to gain approval (CE Marking) for a device in the EU.
Discussion forum for EU Regulatory topics in Advanced MDD course.
A detailed description of the what, why, and how of a DHF. Outlines the structure of the document, what pieces make it up, and how the DHF fit into the flow of device documentation. A detailed comparison between the DHF and the European Tech File/Design Dossier is also explored.
Walking through the steps for filling out a DSD and/or Design Matrix.
Detailed look at Verification and Validation activities. Examples of both types are given, as well as descriptions on protocols and reports for both phases.
Discussion forum for topics on the Design History File in the Advanced MDD course.
Detailed description of what information is contained within the DMR, along with an example given below.
Detailed description of the Device History Record along with an example given below.
Detailed description of the sections of a Standard Operating Procedure (SOP) and the purpose of an Engineering Change Order (ECO).
Discussion forum for topics on Device Documentation in the Advanced MDD course.
A first introduction to Process Validation: definition, major regulations that govern it
Description of when and when not to validate a process in light of regulations from FDA and ISO.
Discussion of the purposes and steps for IQ, OQ, and PQ: Installation Qualification, Operational Qualification, and Performance Qualification
In-depth look at a Process Failure Modes & Effects Analysis and the context of Process Risk Management.
PDF Document of a template for an Installation Protocol.
PDF Document for an OQ Protocol Template
PDF Document for a Process FMEA
Discussion forum on topics of Process Validation and Process Risk in the Advanced MDD course.
Looking at Quality Systems through the lens of a Systems Approach, Process Approach, and Factual Approach.
Basic definitions necessary to understand the QSR and how it works.
Gain an understanding of where and when the QSR applies to a company, and when it does not.
Overview of Management's role according to the QSR, and the process flow for Quality Audits and Acceptance Procedures.
Discussion forum for Quality Systems topics in the Advanced MDD course.
Gain familiarity with the documents and events that led to modern day clinical research.
Students will gain a summarized overview of 21 CFR parts 50 and 56 for rules regarding patient informed consent and IRB's.
Understand the roles played by the Sponsor, Investigator, and Monitors.
Overview of the different types of clinical trials and various parameters defined for each.
Explanation of the attached notes to study for Clinical Research certifications.
A 50-page e-book that summarizes in bullet point form all of the regulations needed for conduction of clinical research, and those that are most asked about on clinical research certification exams.
Discussion forum for topics on Clinical Trials for medical devices in the Advanced MDD course.
Overview of the Product Life Cycle and the first stage, Discovery & Innovation.
Detailed look at what innovation is and how it works during the first phase of the Product Life Cycle.
Learn what happens after commercialization is in full swing, including the functioning of the Product Team.
Discussion forum on Product Lifecycle and Product Management in the Advanced MDD course.
Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch.
As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning. Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia. While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary.