Due diligence is a concept that has been around for a long time. In basic terms, it means doing your homework before making any major decisions about finances, investments, equipment, or more. It can be difficult to research if you don’t know what to look for, which is why MEDIcept offers a due diligence assessment and analysis program. At MEDIcept, we have the experience and expertise to help investors make the right decision and maximize return on investment. We understand regulatory and clinical strategies. We know what it takes to get a medical product to market – we work with these companies on a daily basis. We have assessed investments for companies with a combined value of over $800 million. Read the rest of this entry »

Risk Management Series – Article 9:  Risk Management Report

Foreword

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices;  and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know:   508-231-8842.

Introduction

Our last article, Risk Control and Verification (RM8), described the standard approach (i.e., ISO 14971) for identifying appropriate risk controls – following the priorities: inherent safety by design, protective measures, and information for safety. It also, addressed the importance of verification and provided some guidance for determining the most appropriate approach for conducting your verifications. This article describes the Risk Management Report – i.e., summarizing the work that has been done, assessing the overall residual risks, and describing how risks will be managed going forward.

Risk Management Series – Article 8: Risk Control

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

Our last article, Determining Risk Acceptability (RM7 – Parts A and B), described the standard approach (i.e., ISO 14971) for evaluating medical device risk and assessing the acceptability of those risks. We also identified some challenges that you will face when implementing the standard, and presented some approaches for overcoming those challenges. This article addresses Risk Control – i.e., what to do when you find you identify unacceptable risks.

Just wanted to remind you about the documents that are available to download in the Document Repository; please click here to get to the Document Repository.

Design Verification

Design Verification: This paper explores the use and misuse of Design Verification and how device manufacturers can get the most out of their verification efforts.

Risk Management

Risk Management Series Introduction – Beyond FMEA:
Too often, when medical device companies think about risk management, they think of just two things: Regulatory requirement and FMEAs.

Regulations are not the only reason that it’s important to understand, control, and monitor risks; and FMEAs are not the only tool to do it. This paper kicks off our series on risk management and sets the stage for further discussions.

Risk Management Series Part 2: Prioritizing Risk Management Activities

A key element of the risk management process is to focus the team’s attention on reducing risk that could cause serious harm, but many times risk management teams get lost in the weeds of the risk management process and lose sight of the key issues. This paper provides an approach to help set risk management priorities.

Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis
Many risk management teams jump immediately into the process of filling out the lines of FMEAs before they develop a strong understand of the system they are analyzing. While Fault Tree Analysis (FTA) will not solve all of you risk analysis problems, it will help you to better understand the system you are analyzing and help you to focus the system elements that are most important.

Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs
One argument against using Fault Tree Analysis (FTA) is that your company’s risk management procedure requires an FMEA and there’s no way to link the FMEA and the FTA. Not true. In fact, the FTA will help you prepare a better FMEA that addresses important risks and meets internal company requirements.

Risk Management Series – Part 5: Assessing Severity
One of the most challenging elements of risk analysis is the assignment of a Severity score to a particular hazard or failure mode. On the surface, assigning a Severity score seems pretty straight-forward.  Unfortunately, like most things, the devil is in the details. This paper will help you assess severity more effectively.

Risk Management Series – Part 6: Estimating Probability of Occurrence
Understanding the components of the “Probability of Occurrence of Harm” is critical to understanding your risks.  If your team members each have their own definitions, it will be hard to achieve alignment. This paper lays out a clear approach for estimating occurrence.

Risk Management Series – Part 7: Determining Risk Acceptability – Part A
To kick off this two-part discussion, this paper describes the standard (ISO 14971) approach for assessing risk acceptability – and addressing the RPN questions – setting the stage for a more detailed discussion of the challenges in Part B.

Risk Management Series – Part 7: Determining Risk Acceptability – Part B
The standard risk management approach (ISO 14971) for assessing risk acceptability can get a little complicated. This paper describes some of the key challenges to implementing the standard approach and what to look out for.

Clinical Evaluation Reports

Clinical Evaluation Reports – Tying it All Together (Article 1 of 3)
Clinical evaluation reports (CERs) are required for all CE marked devices – yes, all of them. This article kicks off a series on how best to implement the guidance provided in MEDDEV. 2.7.1. Rev 3.

Clinical Evaluation Reports – Tying it All Together (Article 2 of 3)

Building on our previous article, this article describes key issues to consider when conducting literature reviews, collecting internal/external safety data, and assessing risk management documents.

Clinical Evaluation Reports – Tying it All Together (Article 3 of 3)
This final article in the series provides an outline for the clinical evaluation report that will allow you to tie all the elements together.

Risk Management Series – Article 7: Determining Risk Acceptability – Part B

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

In our last two articles, RM 5 – Assessing Severity and RM 6 – Estimating Probability of Occurrence of Harm, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes the next step to address the question: Are we, as a company, willing to accept the risks associated with our device given the benefits that a patient is likely to receive? This first part of this article (Part A) provided a review of the standard approach. This article (Part B), provides our thoughts on the challenges of applying that approach.

Risk Management Series – Article 7: Determining Risk Acceptability – Part A

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

In our last two articles, RM 5 – Assessing Severity and RM 6 – Estimating Probability of Occurrence of Harm, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes the next step to address the question: Are we, as a company, willing to accept the risks associated with our device given the benefits that a patient is likely to receive? This article (Part A) provides a review of the standard approach. A second article (Part B), will provide our thoughts on the challenges.

Risk Management Series – Part 6: Estimating Probability of Occurrence

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

In our last article, Part 5: Assessing Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and distinguishing between harms that occur as a direct result of the hazard/hazardous situation and harms that will only occur as the result of a series of subsequent events. This article addresses the other major element of risk, the Probability of Occurrence of Harm.

Risk Management Series – Part 5: Assessing Severity

MEDIcept presents this ongoing series of articles focused on the implementation and conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards. Our team at MEDIcept, publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

Our previous articles have focused on the role of risk management in improving device safety, the importance of prioritizing risk management activities, the use of Fault Tree Analysis (FTA), and how to transfer FTA results into FMEAs. In this article, we will begin to explore specific topics related to the conduct of FMEAs by addressing the challenge of assessing the severity of harm.

Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs

MEDIcept is presenting this ongoing series of articles focused on the conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards.

Our team at MEDIcept, plans to use these articles to capture best practices, explore the more challenging aspects of maintaining risk management systems over the long term, and elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

In our last article (Part 3: Using Fault Trees to Focus and Simplify Risk Analysis), we described the basic approach for conducting a Fault Tree Analysis (FTA) and the benefits of using FTA to conduct a comprehensive analysis of the causes of device failures and use errors. We also identified a few weaknesses of the FTA approach – i.e., its structure can be un-wieldy, and there is no efficient way to track the implementation of needed mitigations or document that you’ve verified that the mitigations are effective. These weaknesses are two of the strengths of the FMEA risk analysis format. Therefore, this article describes an approach for transferring risk information from a completed FTA to an FMEA so that you will be able to take advantage of the strengths of both.

Clinical Evaluation Reports 3 of 3

MEDIcept, an international medical device consulting firm is presenting this as an ongoing series of articles focused on Clinical Evaluation Reports in the medical device industry.

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports (CERs) for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance. The last two articles gave a quick overview of CERs, the need for an internal Standard Operating Procedure, and the basic elements of the CER. This article will discuss the final CER report.

If you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.