Manufacturers in the life sciences arena share the same goal: spending less time and fewer resources to develop more reliable products or services. Every manufacturer comes at that goal from a different place—with different strengths and weaknesses, needs, and technological capabilities. But regardless of what goods and services are being provided, the basic stages of the product development process are much the same across the industry.
Not every company will need to go through all stages, in fact, the steps required could vary by product being developed. But the typical ones—concept, scan, design, simulation, test, and submit—cover the range of steps in the process that every organization will have to work through to take a product from idea to production.
Stages in the Typical Product Development Process in Medical Devices
Everything begins with a concept, whether for an innovation or a product redesign. The concept itself begins with requirements, which can come from anywhere, from any stakeholder, be it internal R&D, requests or input from stakeholders, and/or market research. Regardless of the source, agreed-upon product requirements have to be carefully defined and tracked throughout the development process, and robust collaboration methods can help combat what are typically disparate systems in most organizations. Then, from the requirements, a product design is created via advanced CAD tools.
Of course, a product concept isn’t always for mass-production. Often it’s for a baseline product that will be tailored to a specific patient, taking into account differences in bone density, body structure, heart function, or other characteristics. The need for technology to utilize a patient’s real information in simulations is growing in the life sciences field, from implants, stents, and brain simulations for medical devices, to anatomical simulations such as physiological flows and thermal heating, to human body and consumer product interaction like hearing aids and shoes.
In order to simulate reality to create a customized part, manufacturers need to scan the body—in most cases, this means comprehensively processing standard 3D image data, such as MRIs or CT scans and exporting them as models suitable for CAD or CAE. The models can also be used for 3D printing, in cases such as a dentist scanning a tooth to create a crown or a doctor scanning a limb that needs a prosthetic. For example, the Cleveland Clinic and the Veterans Administration (VA) are experimenting with using 3D printers to print custom components to fit knee braces on veterans.
Design is the one step every company performs. The key step in product development, design means taking all of the available requirements and data and developing the end product in a CAD system. Manufacturers who make use of an advanced CAD system tuned to the particular needs of life science applications can perform highly complex design and analysis tasks, including taking photos and converting them to 3D models, incorporating human mechanics and virtual reality, and even reverse engineering physical parts. In
addition, embedded collaboration tools in advanced CAD platforms also introduce the web into tools used for marketing, creating high quality rendering or animations, which helps teams create marketing information and technical documentation for regulatory purposes much earlier in the design cycle.
One medical device manufacturer saw firsthand the wisdom of an integrated, life sciences–appropriate design platform by trial and error. After working for two months with design tools less tuned to the organic nature of life science applications, they abandoned their prosthetic development and started again with an advanced platform—which yielded a satisfactory working design in three weeks that included smooth curves, multiple part assemblies, and complex yet stable models.
A completely digital design file allows for enormous cost savings when it comes to the next typical product development stage: simulation. Traditionally, medical device developers would create a new design, build one or more prototypes, and put them on a piece of testing equipment that simulates use and/or wear to determine how the design functions. The test equipment might need to run for weeks or months before delivering results, and if the product design isn’t robust enough, new designs and prototypes would need to be created and tested for the same amount of time. Not only is this physical testing process time-consuming, but it also can be extremely costly.
For example, companies that develop parts for total knee replacements can spend as much as 12 weeks and $100,000 per test to predict wear on a component over a number of gait cycles. But with simulation packages built into an advanced CAD platform, the same analysis done virtually can take anywhere from 15 minutes to two hours and cost only the operator’s time. The dramatic reduction in time and expense makes it much easier for companies to rapidly optimize their designs for a quicker time-to-market.
The same simulation tools can also help with testing, the next typical stage in the process. An advanced platform can correlate simulations data to real-world use tests, which is akin to putting strain gauges on physical equipment. The unique simulation tools make the real-world testing process more accurate and less costly than any other method out there.
The final stage in the product development process is submitting the product for regulatory compliance. Unfortunately, for many small or even mid-sized companies, the submission process isn’t always well defined and can be especially challenging due to siloed information across the organization. A comprehensive software platform can help here too, particularly with the compilation and collection of information required for submission.
Beyond the traditional process steps, the other challenge for many companies is communication between teams, departments, and particularly information systems. A powerful solution will be built around unified, flexible platform capable of being a central storehouse for all product information, from design and production to documentation and compliance, to support team collaboration and accelerate data-sharing efficiencies.
By creating a single source of information and a single source of the truth within an organization around the product development process — organizations like yours can produce more reliable products with more speed and less cost.
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