Developing a medical device is a risk-prone process. The medical device industry is fraught with hurdles and uncertainties. A staggering statistic states that about 95% of new products fail to make significant sales. In order to minimize the impact of risks, a comprehensive process must be developed by the manufacturer to ensure that a thorough risk assessment is conducted to identify and avoid potential risks through the development lifecycle. Areas of risk through the development lifecycle include regulatory requirements, safety, supply chains, scheduling, and sustainable manufacturing processes. Since minimally invasive devices function within the human body, the FDA also mandates risk assessment as part of every stage of the medical device’s lifecycle.
This article provides an overview of how risk assessment is incorporated into the lifecycle of your minimally invasive medical device.
From as early as the product conception phase, care should be taken to design and ideate around feasible and economic to produce concepts, thinking of mass production in the development stage. Risks do not only concern its medical performance. They also deal with manufacturability, the feasibility of using chosen materials in the manufacturing process, i.e. availability of materials, components, and supply chain risks. In addition, this manufacturing feasibility should not come at the expense of limiting innovation and product features options.
Having someone who has a wealth of knowledge and long-standing experience in the design and manufacture of minimally invasive medical devices, will serve as a major plus in when it comes to risk assessments. An experienced manufacturer will have resources available and research (and researchers) ready to provide necessary data to support or provide a reason to change your device’s design. Having in-depth regulatory knowledge about the FDA’s standards and requirements for testing to be performed on your minimally invasive medical device will also go a long way in cutting down time-to-market and the overall design and production costs.
This phase includes development processes and techniques, with the aim to produce a working prototype that is feasible to manufacture. Once the prototype has been manufactured, it has to be subjected to rigorous testing in order to assess various risk scenarios. For example: If your minimally invasive device is equipped with an electromagnetic sensor, the prototype must be tested for its effect on pacemakers. This is because there have been instances where the functioning of pacemakers have been affected by electromagnetic waves. The prototype must also demonstrate its level of biocompatibility with human tissues through which it is intended to progress. A manufacturer who can assist you with these assessments will certainly save a huge amount of investment.
From a production perspective, you must also examine the size considerations of the device. Most minimally-invasive devices are require micro-manufacturing, you will need both experience and capabilities in order to bring your device design into reality. It’s interesting to note that a medical device manufacturer’s experience and partnerships upstream and downstream in the supply chain all come into play. Medical device product development utilizes a lot of similar parts in a multitude of different medical devices. During DFM and Pre-PFMEA, an experienced manufacturer will have parts vendors readily available, along with valid and cost-efficient supplier agreements, for most of the designed device Bill of Materials (BOM). This saves a tremendous amount of time, money, research, and communication overhead while offering a solid base for advancing and achieving great product time to market.
The goal of the technology transfer phase is to effectively transfer all of the knowledge gained from the previous phases and apply it to mass manufacturing in the medical device design and development process. Risks pertaining to production consistency and cost-effectiveness are just two of the many risk areas that are to be assessed at this stage. A highly skilled medical device development team, consisting of multi-disciplinary, experienced engineers and specialized personnel, can really deliver in the phase of technology transfer. To begin with, the development team should already have established common ground with the operators and technicians of the actual manufacturing line that will produce the medical device. This is very important, as it can greatly affect the communication between device development and manufacturing teams, which is critical for a successful technology transfer. Moreover, this ensures successful production line verification and validation (PVV) testing since development, QA, and production teams have already worked together in the past. The manufacturer’s capabilities with regard to micro-manufacture, automation, clean-room facilities, and availability of production lines to support future demand, should also be evaluated as a potential risk source.
The goal of this stage is to mass-produce the medical device product developed, within budget and according to specifications. An effective turn-key medical device development – manufacturer, would already have addressed mass manufacturing feasibility and regulatory compliance. So at this stage, risks are assessed based on production costs, wastages, manpower requirements, forecasting, market conditions for the uptake of the product, sterilization, packaging and supply chain risk assessments are important to consider. With the pandemic impacting supply chains globally, choose to partner with a contract manufacturer who has strong partnerships and a proven ability to deliver against the odds. You will find that at this stage all the hard work you’ve poured into the previous stages pays off, and efficient medical device manufacturing is as easy as placing the order for the mass production of the first batch of medical devices.
Quasar is an experienced contract manufacturer of minimally invasive medical devices. Our design and production facilities operate based on best manufacturing practices to incorporate risk assessment into each stage of the manufacturing processes, i.e. from concept to market. We consistently demonstrate our stellar quality of services with world-class regulatory bodies such as the US FDA. Consecutive results of zero observations of the FDA Form 483 stand as a testament to Quasar’s impeccably high design and manufacturing standards. Quasar has over 30 years of experience in the industry. Our experts can help you design and develop a world-class minimally invasive medical device quickly and economically and with minimal risks.
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