Author: Juliann Grant

29 Jan 2018

Product Development for Life Sciences: From Digital Concept to Physical Device

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

Concept

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.

Scan

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

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.

Simulation

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.

Testing

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.

Compliance Submission

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.

Visti our Life Sciences page and explore the many projects and capabilities we can help with…

29 Nov 2017

Save the Date: 2nd Annual Customer Conference June 11-13, 2018

 

We are excited to announce the dates for our 2nd Annual Customer Conference:

June 11-13, 2018
The Abbey Resort
Fontana, WI

The agenda is coming together and we will publish it in January. We are organizing educational sessions and hands-on demonstrations that showcase our Digital to Physical Product Lifecycle offerings for Design, Simulation, Additive Manufacturing, Inspection and Quality, Digital Manufacturing, Collaboration and Business Intelligence.

In addition, we will be hosting an “ENOVIA Day” for our customers to see the real power and advancements available in the 3DEXPERIENCE platform.

See our agenda from last year.  Bookmark this page as we will be updating it shortly with a new agenda and general event information.

Registration is free for customers.

Room Rates are negotiated for $109 per night.

We hope to see you there!

 

28 Nov 2017

White Paper: Optimizing Medical Device Development with Full Regulatory Compliance

How to Integrate Quality Throughout Your Product Lifecycle

A variety of factors are vital to the long-term success of a company and a product line, including price/cost, time-to-market, and more. But in this age of global communication—particularly in this era of social media usage, when an opinion or comment can go viral—one of the most important priorities for any company is product quality. That’s especially true for medical device manufacturers—companies whose customers’ lives often depend on the quality of the manufactured product.

The challenge many manufacturers face, however, is maintaining quality, as well as traceability and transparency, not just at one point in the product lifecycle, but throughout. That challenge is often compounded by siloed design, production, and change systems that don’t easily share information with each other or provide accessibility to all stakeholders in the process—something that impacts more than just the product itself.

As a new paper from Dassault Systèmes, “Optimizing Medical Device Development with Full Regulatory Compliance,” notes:

Quality information must be highly visible throughout an organization to ensure that any and all decisions…are informed in a timely, efficient, and accurate fashion.

Unfortunately, even when companies know that quality is so important, they don’t always make it the focus, as they scramble to get products to market or as different teams struggle with poor cross-functional communication. And that’s a problem. As the article points out:

Achieving product quality is a multidimensional challenge and failure to manage quality in an integrated way throughout the total product lifecycle jeopardizes a company’s profitability and reputation.”

The ideal solution is total transparency of the product lifecycle across functions, organizations, teams, stakeholders, and more. And that’s exactly what a PLM system—an enterprise-wide, cross-functional solution that provides a “formalized, systematic approach for managing all aspects of product quality, reliability, and risk”—can deliver.

PLM platforms also help organizations optimize design controls, communication, and product/technology reuse. By handling requirements management for both mass-market manufacturing and specialized, configure-to-order business models, as well as requirements validation through simulation and systems engineering, PLM solutions enable manufacturers to maintain traceability of customer needs being met throughout the lifecycle, from concept to design to finished product feature. In addition, search tools and integrated processes such as quality management solutions save manufacturers money and ensure communication and transparency organization-wide.

In short, a platform-based PLM solutionbreaks down organizational boundaries so companies can achieve the ultimate goal of increased patient safety while delivering innovative healthcare breakthroughs.”

To learn more about how a PLM solution can help your organization, download the whitepaper:

28 Nov 2017
Metal-X

Not Just for Parts: Additive Manufacturing Delivers Benefits with Tooling

The buzz around Additive Manufacturing (AM) tends to focus on making parts—how making production parts via AM brings a revolution to some manufacturers and disrupts some established industries. But while impressive, AM parts aren’t the whole story. An important potential use for AM is often left out, and it’s one that could impact dramatically more manufacturers in more industries. That’s tooling.

First, any discussion of AM for tooling must address the obvious—that there are some instances where AM can eliminate the need for tooling entirely. Companies doing short-run production might simply use AM to create production parts directly, bypassing the need to create tooling at all and shortening their product’s the time to market. But when AM simply can’t compete with the speed and volume of the production line, manufacturers can still reap some of the rewards AM is delivering to other industries.

The automotive industry is a prime example. While AM is in use for some end-use components in custom or small-quantity automobile manufacturers, the larger automotive companies don’t find AM a practical answer for production parts. But tooling for production, testing, design validation, and more could be another matter.

Have It All: Faster, Cheaper, More Complex

One of the primary problems with tooling is time. The product design is finished and you’d really rather have the parts in-hand yesterday, but you’ve not only got to contend with production time for the parts, but also production time for the tooling to produce those parts.

Enter additive manufacturing, which lets you make tooling cheaper and faster than the traditional-machining route. Aerospace provides a case study. While polymer-based materials aren’t being used for flight applications, their use has gained traction in production tooling, according to the Institute of Electrical and Electronics Engineers (IEEE). Particularly for specialized, one-off parts, the speed and cost reduction of producing fixtures, jigs, and other precision tools rather than waiting for them to be machined from metal can be immense. One small aerospace company converted to making tooling in-house via AM, and their tooling timeline shrank to about a week to produce equipment, versus 12-14 weeks for outsourcing parts to machine shops.

That time savings ultimately meant improved ROI because end-use parts could be made sooner. But the in-house AM work also directly saved money on the tooling itself—in-house AM parts cost only about a quarter of the outsourced, machined parts. In general, companies find that AM saves them money, for any of a variety of reasons, including reduced time, reduced material usage, easier rework or replacement, and so forth.

In the automotive industry, tooling is high value and low quantity. By some accounts, according to the Harbour Results consulting firm, car manufacturers spend $50-75 million on tooling each year for each car model, simply for updates and improvements. Any chance to reduce that cost, via faster production or by creating fewer parts because AM can make more complex shapes, could be hugely valuable.

Volkswagen Autoeuropa has recently converted to using 3D printers to create custom tooling, thereby reducing tool-development time by a whopping 95%. In 2016, they saved $160,000 in tooling costs, and they expect to save even more this year (Additive Manufacturing Magazine). One of the additional benefits of AM tooling they cite is the ability to adjust designs or replace worn parts without redoing the entire tool. Another is the flexibility of iterating manufacturing aids, and making improvements via trial and error, which simply isn’t practical when working with external suppliers.

The other notable benefits of AM parts apply to tooling as well, namely the ease with which AM can create complex shapes, particularly internally, and the ability to customize. Once tooling designers start thinking in terms of AM rather than subtractive machining, they can make tools lighter and even stronger in places. The medical industry provides examples of these benefits, such as “tools” that help surgeons learn how to perform particular surgeries or practice for specific procedures on individual patients.

And there’s another benefit to faster, cheaper production of tooling that might contribute to ROI in a more indirect way: employee comfort and satisfaction. As Volkswagen Autoeuropa notes, one benefit of in-house AM work is the freedom to respond to technician concerns and requests to make ergonomic improvements to tooling. Overall, with a faster time-to-tool, tooling can be optimized more readily, which might not only improve the workplace for the employee, but is likely also to result in better tooling.

Industries continue to buzz with the latest in AM developments, such as AM printers that print in metal—like MarkForged’s Metal X—and other innovations. But it’s not that everything can or should be made via AM. It’s more that AM continues to offer new tools in the arsenal for every industry to consider, especially companies and industries that are searching for every technological development and every advantage to remain competitive. It’s worth every manufacturer considering if there isn’t some aspect of your production line that AM could improve. Perhaps incorporating AM could save your organization money and time, and perhaps it could even change company culture by improving the lives of your employees.

 

 

08 Sep 2017

Additive Manufacturing Deep Dive (Part 1): Expanding Manufacturing Scope

Traditional notions of “manufacturing” have been turned on their heads with additive manufacturing (AM). The additive process delivers a variety of benefits that expand AM’s reach and applicability within—and far beyond—traditional fields.

Many different materials can be used in AM, everything from metal to carbon fiber to food or even live biological cells. Because of the additive process, designers can create increasingly sophisticated parts, including complex internal structures that couldn’t be machined, but that preserves part strength and structural integrity while also saving money and weight. Because it’s easy with AM to make those internal structures, even when expensive materials are used, part makers often need to use less of them, while still being able to make optimal use of material properties—some estimates suggest that AM processes can save as much as 90% of raw material costs. And beyond the part level, the sheer speed of creating parts can make entire manufacturing processes faster.

But what’s even more impressive about AM is that it’s making “manufacturing” relevant to unconventional industries—even to situations where every part is custom. In this first of two blog posts, we’ll explore how AM can bolster classic manufacturing processes, and in part two, we’ll look at the growing case for AM to make custom parts, sometimes in the most unlikely places.

AM Shakes Up Traditional Manufacturing

First and foremost, AM has made the concept of rapid prototyping possible for manufacturers by dramatically reducing the time required to create new prototypes for evaluation and testing. For many product or part developers, rapid prototyping has meant a fundamental change in the design process, relying more heavily on fitting actual prototypes together than on spinning and testing computer models. Faster prototyping means faster design and a shorter timeline for getting products to market.

In fact, one AM services provider estimates that by utilizing digital manufacturing throughout the product development lifecycle—from rapid prototyping to product launch—development time could be more than halved over traditional manufacturing methods.

But the product development phase isn’t the only way AM can improve traditional manufacturing. AM can make tooling for the manufacturing process cheaper and faster. In addition, sometimes AM can even produce parts on-demand throughout the process—whether for updates to the product line, updates or replacements for tooling, or short-run parts themselves.

Of course, for manufacturers who pump out hundreds of thousands of parts every week—or day—AM is best used for prototyping and tooling. But for other industries, such as aerospace, that need product design as well as small-quantity production, the ability to produce actual production parts has delivered even more benefits. Real-world examples include Boeing, which uses an AM process to build parts for aircraft. GE has also begun incorporating 3D printing into its jet engine manufacturing process, allowing for a reduction of part weight and yielding a part that’s five-times more durable. In 2016, NASA reported a dozen successful test firings of an all-3D-printed rocket engine. And SpaceX has tested an engine for its reusable Raptor propulsion system that contained more than 40% 3D parts by mass.

Then there are the industries that we don’t normally associate with the term “manufacturing.” The capability of AM to make changes to a design easily, to create custom parts with every printing, and to create those complex internal structures have driven a huge interest in AM by companies in such far-ranging industries as medical devices, food, household items, and automotive supplies.

In the next blog post, we’ll look at industries new to the idea of   AM’s perfect suitability for creating custom parts. But it all comes down to this bottom line: regardless of where AM is plugged into a manufacturing process—whether at the prototyping stage or production—AM speeds it up, and the faster products get to market, the better for the manufacturer.

Learn more about our 3D Printer offerings