TMV is crucial for ensuring reproducibility and consistency not just during product development, but also across different production batches and locations. A validated test method reduces variability between testers, equipment, and environments and helps to maintain compliance with regulatory standards….   Read more»

I would like to add that companies can further enhance the effectiveness of these reviews by adding in simulation and prototyping early in the process. Using virtual simulations such as finite element analysis can help identify design flaws early and…   Read more»

All of these responses provide valuable insights into conflict resolution strategies. I’d like to expand on the importance of emotional intelligence (EQ) in resolving conflicts. A project manager who can recognize and manage their own emotions and understand the emotions…   Read more»

Hey Mirna, I think it’s great that you have a specific career path in mind for your future. While I am not a project manager myself, I have a similar end goal. I’ve looked into the proper steps in transitioning…   Read more»

I agree that balancing in-house and external expertise can be beneficial, however, I would also like to emphasize the product development timeline and regulatory complexity. For projects with tight deadlines, relying only on external consultants can lead to bottlenecks due…   Read more»

The challenges in managing medical device projects are definitely multifaceted, but in my opinion, one of the largest challenges lies in balancing cross-functional collaboration. Medical device projects typically require input from a large set of diverse teams. Be it engineering,…   Read more»

I’d like to add that one of the compounding challenges in this area is how regulatory risks can cascade into other risk categories, such as financial and market risks. Delays in FDA approval not only increase cost because of extended…   Read more»

I agree that where the value goes depends case-by-case. I would also add that a project manager could/should also weigh long vs short-term impacts of favoring one stakeholder group over another. Prioritizing customer needs may foster brand loyalty and growth,…   Read more»

As a business owner, having a detailed and structured plan in place for potential emergencies is essential to ensure the continuity of operations and protect the company’s stability. I believe it is crucial to designate a temporary replacement who can…   Read more»

In medical device consulting agreements, proactive conflict resolution strategies often focus on creating efficient and equitable processes. Incorporating multi-tiered dispute resolution mechanisms, such as negotiation and mediation before arbitration, can foster collaboration and potentially resolve issues early. To address jurisdiction…   Read…[Read more]

Fair market value (FMV) compensation for healthcare professionals is a cornerstone of compliance under the AdvaMed Code of Ethics. It ensures that financial agreements are free from any undue influence on the purchase or promotion of medical devices. To verify…   Read more»

I would definitely recommend consulting for recent graduates, assuming they approach it with intention and purpose. In industries with competitive job markets, consulting provides opportunities for exposure to diverse projects and skill development. Consulting can be a valuable stepping stone,…   Read more»

Consulting and legal services often go beyond simply offering solutions or guidance in the medical device industry. They play an important role in equipping companies with the tools to succeed in regulated environments. One of their more critical objectives is…   Read more»

When drafting agreements such as NDAs, consultancy contracts, or confidentiality agreements in the medical device sector, having a balance between fostering collaboration and safeguarding one’s legal rights requires much thought. It is important to ensure simplicity and clarity in the…   Read more»

The shift to remote work during the COVID-19 pandemic had a massive impact on leadership behaviors and organizational structures, forcing leaders to rethink how they manage, communicate, and drive productivity. Leadership across functional, project-based, and matrix organizations faced challenges unique…   Read more»

Organizational change and development extend beyond structural adjustments or operational shifts; they encompass creating a foundation for sustainable growth, resilience, and alignment with overarching organizational goals. A critical, often underemphasized, aspect of this process is the integration of adaptive strategies…   Read more»

Organizational development (OD) serves as a critical enabler for medical device manufacturing companies to successfully integrate advanced technologies such as AI and IoT. Beyond fostering adaptability and skill development, OD plays a strategic role in aligning the introduction of these…   Read more»

I’ve personally been involved in a CAPA after a few audit findings. First of all, audits are grueling! Any and all paperwork that has ever been documented has the chance to be scrutinized and picked apart and any processes that…   Read more»

I agree that risk avoidance is a foundational strategy in the manufacturing process, but it must also be complemented by mitigation efforts and risk acceptance to ensure a balanced approach. Manufacturing involves certain complexities, and while avoidance is always the…   Read more»

Risk management is an evolving process that extends beyond compliance with ISO 14971 and encompasses a broader integration of proactive methodologies through a device’s lifecycle. One important area not mentioned above is the incorporation of human factors engineering (HFE) in…   Read more»