Advanced Design Tools for Additively Manufactured Medical Devices

While the regulatory and validation burden can be high, it’s not surprising that the medical device industry is one of the earliest adopters of additive manufacturing. This sector already utilizes a variety of advanced manufacturing technologies and more importantly, relies on product innovation to maintain a competitive advantage. Additive manufacturing can affect product innovation on a few different levels, ranging from product performance, time to market, process management, and even supply chain. With the advanced capabilities derived from additive, optimized medical devices that can help improve patient outcomes are possible and readily achievable. Companies of all sizes in the medical space have made significant investments into additive manufacturing, not only as a future technology, but as a proven production process that can be implemented now.

Medical devices on a build platform: spinal ALIFs, tibial trays, and acetabular cups.

The introduction of additive manufacturing for creating advanced medical implants has brought on new challenges for design software when working with complex parts. Engineering software is a key enabler of product development and innovation and nTopology is excited to contribute to this area. Both small and large medical device companies have FDA cleared medical devices that were designed in nTopology software as a part of their workflow.

Additively manufactured femoral stem implants with complex surface structures have a performance advantage of improved osseointegration. (Image courtesy of TU Delft)

nTopology equips engineers with a powerful capability to create products that are impossible to design in traditional software. For example, with nTop Element, engineers and designers can easily create and control lattice structures, a critical part of advanced device design enabled only by additive manufacturing. With the recent addition of nTop Platform, we have extended these lattice capabilities and expanded our application area for more advanced device design and workflow development.

nTop Platform allows for the rapid iteration of designs, quickly sweeping between ordered or randomized structures that promote osseointegration.

Advanced Design Tools

Ordered or randomized lattice structures can easily be created, and lattice unit cell types can efficiently be replaced with others. Advanced design controls such as the fillet between the nodes, beams, and connecting body can also easily be achieved. In traditional tools, modifications like these are time-consuming, impractical, and more often than not, impossible.

Repeatable Workflows

Utilizing a unique system of engineering notebooks allows anyone to capture and control critical workflows for downstream use and distribution.  Created with the intent to expose only the pertinent variables, designers can ensure that organization or project-specific workflows can be locked down and checked into the appropriate PLM systems. This integrated ecosystem of notebooks enforces adherence to standard operating procedures and provides an avenue to capture and reduce design guideline tribal knowledge.

Repeatable workflows such as applying porous structures across a large part family is easily achievable. The ability to design these repeatable workflows allows engineers to automate low-level tasks and focus on the engineering work that matters, such as design iterations and verification – all possible within the nTop platform.

Four medical devices, all with distinct lattice design space geometries, created from the same algorithm nTop Platform. Substituting only the input design region ensures efficiency and repeatability in the design process.

Data Management

Speed, efficiency, and data management are crucial for the best possible product development process. Combining the software architecture, block system, and backend implicit modeling technology in nTop Platform results in robust data and process control. Blocks represent functions, which can be useful for precisely controlling the shape of a model, interpretation of analysis data, or manufacturing process control parameters. Functions can be locked down and version controlled. If there is a change to a nTop block or function, the system is meant to be a living engineering document that works with the engineer throughout the product development process.

The algorithms in nTop Platform form the backbone of the software. As nTopology continues to grow and improve the software, we want to guarantee that the changes we implement do not invalidate a user’s pre-existing process workflow. In acknowledgment of what the implications are to a validated medical device, our production-ready blocks will each retain their own unique version numbers that are independent of the software version. New block versions will become available as needed when nTopology continues to release new versions, but all legacy block algorithms will still be supported and accessible regardless of how the software matures.  

What does this mean for you as a medical device designer?  This means that your FDA validation will no longer be the reason why your software continues to live in the stone age.  A reference to the block version rather than the software version itself allows the old ways and the new ways to all live under a single roof.

nTop platform is a powerful tool in a medical device designer’s toolbox. From complex geometry creation, repeatable workflows, and data management – nTop can be utilized as a key competitive advantage for product development. Interested in learning more? Contact us here to request a personalized demonstration to see how nTop Platform can help improve your designs and processes.