As discussed, arbitration, mediation, and jurisdiction clauses certainly influence consulting relationships, even before any conflict arises. However, one area that particularly deserves emphasis is predictability’s impact. When consulting agreements clearly define escalation step-by-step, from negotiation to mediation to arbitration, they…   Rea…[Read more]

Ring fencing is both a stabilizing strategy for company acquisition and a formidable source of frustration for employees. Fiscally, it makes sense for purchasers to seek protection for their investment and ensure continuity during the transition period, particularly during an…   Read more»

I certainly agree that documentation, from consulting agreements to time logs/deliverables, is critical as a clear, auditable trail connecting payments to legal services rather than product influence. However, I would like to add that many companies necessitate internal legal/compliance reviews…   Read more»

I agree that medical device companies must prioritize patient outcomes and cost-effectiveness to run their corporations and practice efficient, value-based healthcare. The responses thus far have covered data analytics and partnerships with healthcare providers, which are needed to demonstrate measurable…   Read more»

I definitely agree that the choice of matrix structure should depend on the project, rather than being a one-size-fits-all situation. Reading the responses, I see that a strong matrix is preferred in highly regulated projects as it would enable faster…   Read more»

I think the way you outlined that the balance of power between project managers and functional heads as the critical factor of whether matrix organizations works or does not is quite strong. Furthermore, I actually thought your examples highlight something…   Read more»

The key to determining whether a risk is truly worthwhile lies in evaluating how integral that risk is to the product’s intended use. However, it is crucial to strike a balance between ethical responsibility and technological progress. For example, in…   Read more»

I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like to introduce the additional risk of patient-specific failure in electro-pad adhesion. For example, excessive body hair, sweat,…   Read more»

I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participants are invited to engage. Personally, I believe that the combination of preparation, rotating facilitators, and…   Read more»

An important dimension to consider is how risk-based approaches guide companies in retrospectively building a DHF for legacy products. Legacy devices already have a level of technical documentation, however, the focus has been more on demonstrating current safety and effectiveness…   Read more»

The Therac-25 disaster serves as a poignant reminder of the vital importance of design controls and verifications in medical device development. I realize that modern frameworks (e.g., IEC 62304 and ISO 13485) have greatly enhanced oversight and traceability, but I…   Read more»

I wanted to add that the way design controls are perceived also goes a long way. A lot of tension is generated, I think, when design controls are viewed simply as a regulatory burden rather than a way to augment…   Read more»

When transferring design controls to a contract manufacturer, it is critical to maintain traceability and design intent throughout the production process. Even if contract manufacturers have strong QC & QA systems, there can still be gaps if communication/documentation is not…   Read more»

An interesting perspective is how emerging development models (e.g., human-factors-driven design) are reshaping the distinction between verification and validation. In traditional systems, V&V has been more linear to align with regulatory expectations. However, in new iterative development cycles, teams now…   Read more»

Another perspective to consider is how regulatory and ethical obligations can affect the balance between user needs and business constraints. In other industries, such as consumer technology, compromises between the two may result simply in less convenient user experience. However,…   Read more»

Based on the responses thus far, transparency, bias, and privacy seem to be the three most critical and identified ethical challenges for using AI. I want to expand a bit on the accountability aspect, which becomes increasingly complex as AI…   Read more»

Virtual trials and telemedicine have certainly bolstered the inclusivity of recruitment, but another promising development is the use of real-world data (RWD) and artificial intelligence (AI) to select subjects more efficiently. There are CROs who are now increasingly partnering with…   Read more»

I agree that patient safety and data integrity are critical to ethical clinical research, and the principles of ICH-GCP certainly operationalize such goals. For example, ICH E6 (R2) emphasizes accurate documentation along with risk-based quality management systems, enabling sponsors and…   Read more»

Zoom is a company experiencing rapid growth due to its optimization of telehealth and virtual care. Despite Zoom being originally a video conference platform, Zoom now holds 36% of the US national telehealth market, with the industry projected to grow…   Read more»

AI can certainly transform medical device marketing, particularly when it comes to understanding audience behavior and personalizing outreach. However, I think the real issue is striking a balance between the autonomy it should have in shaping medical communications and oversight. …   Read more»