How does the design of surgical power tool systems work?

This blog is intended as a brief introduction for orthopaedic surgeons on how the design of surgical power tool systems works in factories.

When producing surgical power tool systems, how are user needs identified and how does the product development system work?

User requirements are the first step in the design files of medical devices. Surgical power tool systems used in the field of orthopedics, like all other medical devices, are produced by taking user requirements into account during the design phase and in such a way that the needs can be met at the highest possible level. User requirements can be old and current users of the product, or input is provided by taking into account the feedback of users of equivalent devices. All these collected needs are prioritized.

What is the prioritization based on?

The first step in design is to succeed in producing a safe device. Safety is examined in various areas such as electrical and design safety. All safety verifications are done by creating the worst case scenario. The design safety of surgical power tool systems is ensured by a device ergonomics that can be safely used by the surgeon with the smallest hand physiology among the surgeons who will use this product.

Medical device risk management and safety requirements are an area where manufacturers have to update themselves in line with the standards and work throughout the product life, taking into account user requirements. These studies are audited by the companies that issue quality certificates and they inform the Ministry of Health records of the relevant country annually about whether compliance is maintained or not.

Surgical power tool systems consist of an internal motor that gives powers such as torque, speed, oscillation, and mechanical parts with an electronic driver to perform the operation with the rate directed by the surgeon through the trigger. At the same time, all selected products are expected to both meet the expected performance and operate safely. Minimization of the surgical power tool system depends on the proportions of the semi-finished products used in this context. Depending on technological developments, surgical power tool systems can also be produced in more ergonomic sizes as of 2024 and can serve our surgeons with small hand physiology.

Evaluation

Reliable and regulated manufacturers are aware that patient safety is in the hands of orthopedic surgeons. These manufacturers take a holistic view of the healthcare sector and try to realize designs that can support surgeons as much as engineering conditions allow. In other words, the feedback collected from surgeons constitutes the main inputs of surgical power tool systems design studies.

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