In the complex world of litigation involving medical devices, finding the right expert witness can make or break your case. Medical device cases often involve intricate technical details, regulatory standards, and real-world application nuances that require an expert with specific knowledge and experience. Whether you are representing the plaintiff or the defense, a medical device expert witness can provide critical insights that clarify issues for the court and bolster your argument.

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This article will guide you through the steps to find the right medical device expert witness for your case, ensuring their qualifications align with your needs and their testimony enhances your case.

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1. Understand Your Case Requirements

Before you begin your search, it is essential to understand the specifics of your case. Medical device litigation can encompass a variety of issues, including:

• Product liability

• Design and manufacturing defects

• Regulatory compliance (e.g., FDA standards)

• Failure to warn or inadequate labeling

• Clinical performance and outcomes

• Post-market surveillance and adverse event reporting

Clarify the nature of the claims and the type of expertise required. For instance, if your case involves a failure in the design of a prosthetic device, you may need an expert with an engineering background. Alternatively, if the case revolves around regulatory compliance, you might need someone with experience in FDA submissions and processes.

 

2. Identify the Necessary Expertise

Medical devices intersect with several fields, so identifying the exact expertise needed is critical. Consider the following when narrowing down the qualifications of your expert:

Technical Background

The expert’s educational and professional background should align with the device in question. For example:

• Biomedical engineers for mechanical and electronic devices.

• Materials scientists for issues involving device durability or failure.

• Physicians or surgeons who specialize in the area of medicine where the device is used.

Regulatory Knowledge

If the case involves questions of FDA compliance or device approval processes, look for an expert with direct experience in these areas. Former FDA employees or consultants with expertise in navigating the 510(k) or PMA processes can add significant value.

Litigation Experience

Testifying in court requires a unique skill set. Experts with prior litigation experience will be familiar with the discovery process, depositions, and courtroom procedures. They are also likely to present their findings more effectively to a jury.

 

3. Use Professional Networks and Expert Witness Services

Finding the right expert can be a time-consuming process. Here are several resources to streamline your search:

Professional Networks

Reach out to professional organizations related to medical devices, such as:

• The Biomedical Engineering Society (BMES)

• Regulatory Affairs Professionals Society (RAPS)

• American Institute for Medical and Biological Engineering (AIMBE)

• A referral service such as Expert Strategy Group

These organizations often have directories or can recommend qualified members.

 

Expert Witness Services

Expert witness referral agencies such as Expert Strategy Group specialize in connecting attorneys with experts in various fields. Referral services vet experts for qualifications and litigation experience, saving you time and ensuring quality. We offer a diverse roster of medical device experts, ranging from engineers to clinicians and regulatory specialists.

Academic Institutions

Universities with strong biomedical engineering or medical programs can be excellent sources of experts. Reach out to faculty members who have published research or have hands-on experience with the type of device in question.

Industry Professionals

Professionals who have worked directly in the medical device industry, such as engineers, product managers, or compliance officers, may have the practical experience required for your case.

 

4. Evaluate Credentials and Experience

Once you have identified potential experts, thoroughly vet their qualifications. Key factors to consider include:

Educational Background

Ensure the expert has a strong academic foundation in their area of expertise. Advanced degrees (e.g., PhD, MD, or MSc) in relevant fields can lend credibility to their testimony.

Professional Experience

Look for an expert with hands-on experience related to the medical device. For example, if the case involves a cardiac stent, an interventional cardiologist or a biomedical engineer with direct experience in stent design would be ideal.

Publications and Research

Experts who have published peer-reviewed articles, white papers, or industry guidelines demonstrate a deep understanding of their field. Publications also show that their knowledge is current and respected within the industry.

 

Litigation History

Check if the expert has testified in similar cases. Ask for references or a summary of past testimony to assess their effectiveness under cross-examination.

 

5. Assess Communication Skills

Conduct an interview call with potential Experts. Even the most knowledgeable expert will fall short if they cannot effectively communicate their findings to a lay audience. A good medical device expert witness should be able to break down complex technical concepts into simple, relatable terms for the court.

Testimony Style

Request a sample of previous testimony or prior written report. This will give you insight into how well they handle questions, explain technical details, and maintain composure under pressure.

Clarity and Confidence

During your initial discussions, evaluate the expert’s ability to convey their thoughts clearly and confidently. A credible expert should be comfortable discussing their opinions and supporting their conclusions with evidence.

 

6. Verify Independence and Credibility

An expert witness’s credibility is paramount. Courts may scrutinize an expert’s impartiality and objectivity, so it’s essential to choose someone without conflicts of interest.

Impartiality

Avoid experts with financial ties to the parties involved in the case. Their testimony may be challenged as biased.

Fee Structure

While experts are compensated for their time, exorbitant fees or payment tied to the case outcome may raise questions about their objectivity.

Reputation

Research the expert’s professional reputation. Any history of disciplinary actions, ethical violations, or problematic testimony can undermine their credibility.

 

7. Prepare Your Expert Thoroughly

Even the most seasoned expert witness needs to be well-prepared for your specific case. Provide them with all relevant documents, including:

• Case briefs

• Device specifications and testing reports

• Regulatory filings

• Clinical trial data

• Deposition transcripts and other discovery materials

Ensure the expert understands your legal strategy and the key points you need them to address. A well-prepared expert will be better equipped to provide clear, consistent, and persuasive testimony.

 

8. Monitor Changes in Standards and Technology

The medical device field evolves rapidly, with new technologies, updated standards, and changing regulations. Choose an expert who stays current with industry trends and developments. Their ability to address emerging issues can strengthen your case and prevent opposing counsel from capitalizing on outdated knowledge.

 

Conclusion

Finding the right medical device expert witness requires careful planning, thorough vetting, and a clear understanding of your case’s unique requirements. By identifying the necessary expertise, leveraging professional networks, and evaluating candidates based on credentials, communication skills, and credibility, you can secure an expert whose testimony strengthens your position.

Remember, a well-qualified and prepared expert witness doesn’t just provide technical insights—they bridge the gap between complex medical device issues and the court’s understanding. With the right expert by your side, you’ll be well-equipped to present a compelling case and achieve the best possible outcome.

 

By following these guidelines, you’ll have a roadmap for selecting a medical device expert witness that meets your case's demands and instills confidence in your legal team and the court.