Originally published on fastradius.com on March 31, 2021
Medical device development is a time-consuming and laborious process, with the typical time to market averaging three to seven years. While this may seem relatively short compared to other medical products (new drugs take an average of 12 years to bring to market, for instance), the medical device product design process must account for a number of complex variables.
Crucially, product teams have to build devices that are safe — if devices fail or have performance problems, these issues must not introduce new threats to patient health. Further, many medical devices must be made of biocompatible materials. Beyond key safety considerations, all medical devices must achieve ongoing compliance with all applicable regulations.
Furthermore, product teams are likely going to be balancing stakeholder demands with the unique requirements of the project (such as specifications regarding size, aesthetics, cost, and more). Because the landscape of medical device design is so complex, juggling competing priorities and considerations often requires many rounds of prototyping to reach the perfect solution.
While product teams will inevitably be forced to juggle many competing priorities, a critical concern will likely be cost. Luckily, designers and engineers can take cost considerations into account early on in the product development process and eliminate resource and labor costs during the prototyping phase.
Considerations regarding the cost of medical device development
The medical device product development process can quickly become very cost-intensive in an already cost-intensive field.
The Food and Drug Administration (FDA) classifies medical devices according to the potential risk they pose, with higher risk devices being subject to more regulations, inspection standards, and approval pathways — all of which significantly adds to the cost of development. The average cost of medical device development and rollout for Class I or II medical devices is $31 million, while Class III devices — which are subject to the FDA’s stringent Premarket Approval (PMA) process — cost an average of $94 million to bring to market.
However, these figures do not account for the complexity of devices innovated in the last decade, and some statistical models predict that bringing a complex medical device to market could cost closer to $526 million.
As you put resources into modeling, development, design optimization, and redesigns, it’s important that you also find ways to minimize costs along the way. There’s a lot of money on the line, which is why getting the most out of each round of prototyping is an important part of economically creating a high-quality, high-performing product. Luckily, there are some simple ways to make the medical device development process more efficient and cost-effective.
Match material selection to prototyping stage
The end-use application and performance requirements should be significant drivers in determining the ideal material(s) for a given part — and medical device components are no different. Medical devices (especially those like pacemakers, joint replacements, and other implants) often need to be both biocompatible and hardy enough to last the duration of the device’s intended life cycle.
However, not every prototype model needs to be made from end-use materials (especially if these materials are expensive). Proof-of-concept prototypes, for example, simply need to provide a simple, physical model of the device, and can often be made from more affordable materials like aluminum or plastic resin.
Functional prototypes that demonstrate how the part meets the desired performance, usability, and manufacturability parameters should always be fabricated using the same materials that will be used to produce the final part.
Choose the appropriate manufacturing technology
Many medical devices are actually complex assemblies (comprising intricate components and multiple advanced materials) that require several manufacturing methods to produce. Ensuring that the unique advantages of specific manufacturing processes are properly aligned with the given stage of prototyping is another way to improve the efficiency of the process while also reducing production costs.
For instance, prototyping with CNC machining allows for precise parts, short lead times, and few material compatibility issues, whereas 3D printing and prototyping medical devices makes it possible for you to create plastic parts with intricate geometries or internal cavities that would be difficult if not impossible to produce through other means. Another advantage of additive manufacturing technologies is that they require far less set-up, CNC programming, and tooling — once the CAD file is ready to go, printing can begin.
That said, keeping a variety of different manufacturing machines, tooling, and raw materials on hand is rarely economically effective for product teams. Luckily, in most cases you should be able to outsource your prototyping to a medical device manufacturer, which saves on high overhead expenses and allows you to more cost-effectively test which methods produce the ideal results.
Design with DFM principles in mind
Design for Manufacture (DFM) is a design framework that prioritizes the importance of making parts as simple and straightforward to manufacture and assemble as possible. Streamlining your part designs so that they achieve desired performance characteristics while remaining feasible to produce via your chosen method can reduce not only production costs, but also prototyping costs.
This is another place where outsourcing to a dedicated manufacturing company can be a prudent investment. Product teams designing medical devices are predominantly concerned with ensuring that the complex piece of equipment functions as intended, and often aren’t as familiar on DFM principles. Professional medical device manufacturing companies should be able to analyze part designs and offer tips for refining these designs for manufacturability, which helps prevent costly redesigns down the line.
Stop feature creep
Feature creep is what happens when features or capabilities beyond the core design requirements are incorporated into a part’s design. Additional features can be tempting — if a medical device only performs one purpose, what’s the harm in giving it a few more capabilities or functions?
However, added features, manufacturing complexity, and aesthetic considerations can all increase production costs, with two of the most significant contributors being tight tolerances and surface finishes.
Extremely tight tolerances can be tempting for aesthetic reasons (e.g., a lack of visible part lines), but these come at higher costs. If tight tolerances are necessary, they should be applied solely to the specific features that require them, not the entire part.
Some medical device applications require surface finishes (especially high-polish and mirror finishes) for sanitation and cleanliness purposes, but many types of medical equipment are perfectly functional without such a high-quality polish. Surface finishing can quickly become expensive, so this is another feature to limit except where absolutely necessary.
Use modern software to model prototypes faster
Designing, manufacturing, and testing your prototypes physically generates unnecessary scrap and consumes valuable time and resources. Performance modeling tools can further streamline the prototyping process, as software now enables you to create and test the performance of part designs digitally. These tools enable you to test multiple designs more efficiently, weeding out the non-viable options until only the best-suited part design remains.
Furthermore, you should take advantage of lean/rapid design practices to develop and test prototypes quickly. The development of 3D printing technologies in particular make it possible to put real models into the hands of patients, doctors, and other key stakeholders early on in the process. This allows you to collect and incorporate preliminary feedback while still in the design stage, preventing the likelihood of encountering unexpected design or function issues downstream.
Cut the cost of medical device development with a trusted manufacturing partner
Medical device manufacturing is a complex arena, and there’s a lot of hard work that goes on behind the scenes. Ensuring that devices are able to function as intended, prove durable and reliable over the course of their designated lifetime, and remain affordable to both produce and purchase can be a tall order. Partnering with an experienced on-demand manufacturing is the ideal way to bring your designs to life while keeping costs low.
At SyBridge, our team of engineers, designers, and technologists brings years of experience to the table, including in the medical device manufacturing field. With a deep understanding of the medical device regulatory environment, we can guide you through everything from safe and effective material selection and rapid prototyping to production and fulfillment. Contact us today to learn more.