Using Design FMEAs to Manage Medical Device Design Risk
The Design Process fails any time a Medical Device Design Specification (i.e. dimension, material property and/or software code) is released to manufacturing that results in a medical device being built that does not meet one or more of its design requirements. When this happens both the company who designed the medical device and the end customer are exposed to risk.
Unfortunately, due to the volume of design requirements for a medical device and the fact that some design requirements may compete, it is often impossible to define Medical Device Design Specifications that define a product that will not fail. Although no design failures are the goal, the Medical Device Design Specifications must be optimized to define a medical device that does not exceed a failure rate acceptable to the customer and the company who designed the product. The Design FMEA and its supporting Design Verification Plan provide a systematic method for accomplishing this task. Using a medical device of the classes choice, attendees will learn how to use the Design FMEA and Design Verification Plan to “risk optimize” the Medical Design Specifications.
Along with the Design FMEA fundamentals, attendees will learn the common mistakes found in 99% of Design FMEAs and how to avoid them. They will also be shown how to spend an average of 15 seconds or less on each Design FMEA rating thus removing one of the most significant ways people waste time when performing Design FMEAs.
The key role the Design FMEA and Design Verification Plan play in meeting the risk-based thinking requirements of ISO 13485:2016 will be explained.
If material is presented using a multi-day Workshop, the goal is to provide a Design FMEA and Design Verification Plan of “Customer Delivery Quality” as well as educate attendees on the fundamentals of their use and creation.
Who Should Attend:
: All personnel who are responsible for the creation and maintenance of medical device designs should attend the class.
Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrustructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
Students must have knowledge of the product that they choose to use for the class exercises. If they exist, Requirements Risk Assessment (RRA®), Product Design Requirements documents, prints and bill of materials for product that the Design FMEA and Design Verification Plan will be developed for should be brought to the session.
Class (One Day); Workshop (Two to five Days depending on product complexity).
- The role of the RRA®, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan in the product development process;
- Linkages between RRA®, Design FMEA, Design FMEA, Process FMEA, Design Validation Plan, Design Verification Plan and Process Control Plan.
How to Perform a Design FMEA:
- Elements of the Design FMEA that can be derived by the Requirements Risk Assessment if one exists;
- Eighteen categories of design requirements that must be considered;
- Typical and special case failure modes;
- Typical and special case effects;
- How to determine Severity (SEV) ratings in two minutes or less;
- Two required elements of a Design FMEA failure cause;
- How to determine Occurrence (OCC) ratings in 15 seconds or less;
- The difference between prevention and detection controls;
- How to determine Detection (DET) ratings in 15 seconds or less;
- How to calculate the Risk Priority Number (RPN) and why it should be rarely used to determine what to work on;
- How to determine class designations in the Design FMEA and their importance in determining what must be worked on;
- Why class designations in the Design FMEA are not transferrable to the Process FMEA;
- The only allowable types of Recommended Actions.
Medical Device Type:
Step by step method for performing DFMEA for implantable device including tools used for implantation and implant site preparation;
Step by step method for performing DFMEA for non-implantable medical device
How to Construct a Design Verification Plan
- The purpose of the Design Verification Plan;
- How the Design FMEA can be used to assist in filling out the Design Verification Plan;
- How to use the results of the Design Verification Plan.
- Alternate uses of the information contained in the Design FMEA;
- Obstacles to implementing Design FMEAs and Design Verification Plans effectively.
"Harpco Systems provides some of the most technologically advanced FMEA software tools on the market, buts its their disciplined technique that further separates them from all the rest. Harpco breaks down the barriers and corrects the pitfalls so companies can reap the full benefits of FMEA. Class room training not only properly teaches FMEA, but participants actually build their business's FMEA as they go and are often blown away by how much work got accomplished. Harpco Systems has become known as the Modern FMEA for a reason. Its structured, simplified and sustainable. Thanks Richard for opening our eyes and the FMEA Flip is awesome!"
I have been working with Harpco Systems for 20 yrs and have seen how their products and services continue to improve to meet customer demands. Harpco’s training is first rate and helps develop new ways of thinking about the importance of creating proper specifications early. Separately, I’ve seen firsthand the effectiveness of using their approach in problem solving, helping to advance problems that had reached a stall using traditional methods.
Rich was asked to help us put together a Design Control and Risk Management program for our Immunodiagnostics products. Rich worked with us to build the necessary infrastructure to make the system comprehensive for the level of complexity needed to handle our products. During this time, Rich was not only helpful in putting the system in place, but also educating us on the thought process to evaluate product design and process control. In doing so, Rich provided us with the fundamental concepts to be able to decompose any product or process problem to arrive at an effective solution. He has left a lasting impression on our organization.
We were very fortunate to work with Rich Harpster and his team as we improved our DFMEA process at Calsonic. There is no better teacher, coach, implementer than Rich when it comes to creating a knowledge base for engineers to use in creating part specs to assure that products meet the customer's requirements.
"I would like to thank Harpco Systems for the help, advice and frankly the education in how to design, develop, source and manufacture new to world products. Not only was the Harpco Systems process scrupulously meticulous in making us evaluate, question, define and then justify every single aspect of our product design, project risks and manufacture process, it was done at a pace that saved us months by not following our conventional processes. By cutting out all the waste and focusing our resources on what was truly important Harpco Systems enabled us to get to a state of production readiness months ahead of our projected schedule. This combined with the incredibly detailed, well documented and most importantly correctly linked/associated technical and risk file information prepared us with a watertight project file with no liabilities missed. Harpco Systems has changed the way myself and others approach product design and development for the better."