Managing the competing needs of different stakeholders and the market for a medical device is one of the biggest and most important difficulties that has to be addressed. Investors, regulatory agencies, and top managers in the businesses, for example, focus…   Read more»

Focusing on time, cost, and scope during the design and development life cycles of a medical device is one of the challenges of project management commonly known as the ‘Project Management Triangle.’ The focus on these aspects is very crucial…   Read more»

An essential strategy for avoiding scope creep and delivering a successful project is developing a dynamic risk management strategy. Dynamic risk management is based upon the idea that it can catch scope creep early before it starts to affect the…   Read more»

@ms3548 Underestimating regulatory requirements is indeed a common pitfall that does not get enough attention in my view. Implementing steps for early and continuous regulatory engagement can ensure a company can properly plan their pathway for receiving approval for their…   Read more»

Regulatory agencies should feel the need to adapt faster to keep up with the innovation happening in the medical device field. As it was mentioned, AI may become much more prominent in modern medical as it has potential to be…   Read more»

When transitioning to new technologies during an ongoing project, one thing to ensure is to stay compliant with regulations. Sometimes just merely changing the temperature of a certain stage of the product’s production by one degree is considered a Design…   Read more»

Sizes of project teams must directly reflect the amount of responsibility that is needed in the completion of it. I do prefer smaller teams since I feel like actions and decisions are taken with much more agility, and they are…   Read more»

Companies should embed regulatory planning into every stage of product development rather than waiting until the latter phases. Involving regulatory specialists from the beginning helps guide the design process, determine the appropriate testing strategies, and align clinical study planning with…   Read more»

Medtech project managers could argue that managing compliance while pursuing innovation in the design and engineering of medical devices is a delicate balancing act. While innovation is an important component for medical improvement, which could lead to improved patient care…   Read more»

Each stage of medical device development invariably results in a conflict amongst team members due to the vast areas of expertise required. Engineers, regulatory affairs, quality engineers, marketing staff, and clinical researchers all have completely different needs and priorities during…   Read more»

Establishing a clear regulatory strategy is key in medical device project management since it affects time to market, product effectiveness, and cost efficiency. In the absence of a defined route to receive regulatory approval, even the finest medical devices are…   Read more»

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospective, misclassifying a medical device within the wrong section can be detrimental. The…   Read more»

Intended use and the technological features of a device is usually the focus when determining which regulations apply to a product. Small distinctions in the function of a medical device can solidify which category the medical device would fall into….   Read more»

Design change requests (DCRs) are bound to happen in the development of a medical device either through user suggestions or feedback, risk analysis, adherence to regulations, or incorporation of new technologies. Nevertheless, unmanaged changes that are made later in the…   Read more»

Design reviews are critical in the development of medical devices to manage risks, gain compliance, and improve the product before failures that are costly in nature arise. Medical products are unlike any other product. While other products can be tested…   Read more»

Design verification is one of the phases in medical device development that serves the purpose of ensuring that the device has achieved all of the design specifications, performance capabilities, and regulatory expectations set for it prior to moving forward with…   Read more»

One product that comes to mind when discussing product life cycles is the stethoscope. The acoustic stethoscope has been used since at least the 1850s and has stayed as a reliable tool for clinicians. Electronic stethoscopes have entered the market,…   Read more»

Traceability and adaptability requires a systemic change control process in order to maintain efficiency. One example of this would be features embedded within digital project management tools. A traceability matrix which is updated based on a version-controlled requirements document could…   Read more»

The probability of having to change the budget for additional experiments during a verification test depends on several factors, 1) Strict protocols: If the design has to meet strict parameters, variation in input and output can cause repeating the process….   Read more»

iThe Plan-Do-Check-Act (PDCA) cycle is undeniably a cornerstone of continuous improvement in medical device development, helping organizations maintain compliance while iteratively refining their products. However, its effectiveness depends largely on how well it is integrated into both company culture and…   Read more»