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. Prior...

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 c...

In medical device consulting agreements, proactive conflict resolution strategies often focus on creating efficient and equitable processes. Incorporating multi-tiered dispute resolution mechanisms, s...

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 influenc...

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 ex...

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 regu...

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 ...

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 pro...

Organizational change and development extend beyond structural adjustments or operational shifts; they encompass creating a foundation for sustainable growth, resilience, and alignment with overarchin...

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 adaptabilit...

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 a...

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. Manufactu...

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 n...

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredibly important. Failure Modes and Effects Analysis (...

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical iss...