By Sean Fenske, Editor-in-Chief

Product development is a fascinating and exciting time for any project. At that stage, engineers are working with what’s essentially a blank canvas. Sure, parameters and goals are defined, but how the elements materialize and take shape is still very much in flux during this period of the product lifecycle. Revelations can be recognized and implemented, bringing new ideas to life.

This is also a period, however, where design experience can help facilitate a successful outcome. As such, working with development and manufacturing partners at this early stage can provide more comprehensive expertise in areas where the OEM’s engineers may be challenged. Better still, when a partner has a program to accelerate the development process, greater benefits are realized.

One company that offers a unique, in-person development experience for its OEM customers is Elevaris Medical Devices. In the following Q&A, Tom Graham, the organization’s Chief Operating Officer, explains the novel design opportunity the company provides, the advantages it affords, how it differs from rapid prototyping, and the remote option for it.

Sean Fenske: First, your company name is new to the industry, but the experience of the firm is not. Can you explain a little about what Elevaris is and how it came to be?

Tom Graham: Elevaris Medical Devices is the new brand identity for the companies formerly known to the industry as Spectra Medical Devices and XL Precision Technologies (XLPT). The unified brand brings together two CDMOs with highly synergistic technologies and capabilities. Elevaris is leveraging a proven legacy of excellence to usher in a new era of precision medical device development and manufacturing capabilities.

Spectra was a well-established contract manufacturer, supplying top-tier device companies with specialized needles for surgical applications and drug delivery. XLPT was a rapidly growing manufacturer and design services contractor, providing instrumentation and surgical equipment components to a wide range of medical device manufacturers.

Fenske: More contract manufacturers are incorporating design and development services to become CDMOs. Why are the design and development aspects being included in the services offered?

Graham: Historically, medical device companies looking for component or sub-assembly suppliers have relied on the knowledge of the CMO to optimize the manufacturability, performance, and economics of their devices. This is particularly relevant in new product development programs where design for manufacture (DFM) is a critical consideration. This DFM service has developed further with CDMOs offering partial or full design services to medical device manufacturers, turning functional and reliability specifications into final designs. Even in second-sourcing or transfer projects for supply chain teams, there are minor variations in the final solution to deliver equivalence. Capturing the engineering expertise in the contract manufacturing network is a hugely valuable opportunity for both parties.

Fenske: You offer a unique design process you refer to as live prototype iterations? What is this process?

Graham: We introduced the XLerator program nearly a decade ago after seeing many examples of the benefits provided to device developers through close collaboration onsite in our technology centers.

With it, we provide a full team of relevant technical support—project engineers, process development engineers, manufacturing technicians, and machine operators—together with access to all our manufacturing process technology and inspection capability. We invite our customers’ R&D engineers to share our facility and provide a development environment within our manufacturing areas.

Before their arrival, the R&D engineers will have already provided either a first iteration design or a rough idea for their device assembly. Upon their arrival, we have the first actual parts ready for them to evaluate or test in the device.

The engineer can quickly determine minor changes required to improve performance. The Elevaris team will convert the change into a new manufacturing program or process parameter change and immediately produce more samples.

The customers get to see and share the manufacturing processes, better understanding what is achievable, and influence the solutions. Depending on the process and design complexity, we can usually turn between four and eight design iterations in one day.

Fenske: How does your live prototype iteration process differ from rapid prototyping?

Graham: The traditional, well-used development method for new device projects is to build prototype devices using in-house and subcon manufactured components. The engineer will usually issue an RFQ for prototype components and spend approximately two to four weeks on quotes, interactions, and selection. Then, the engineer will order the first batch of components, which requires a lead time of anywhere from two to eight weeks. The engineer will build and test the assembly, redesign it, and repeat the process.

The live iteration process covers all this activity through several real-time loops but eliminates the waiting and logistics. We don’t claim that it will produce all the answers in one session or provide a final design, but it will accelerate the program significantly.

Fenske: What are the benefits of live prototype iterations? What can customers expect?

Graham: The benefits are abundant. Among them is the direct connection to our engineers’ knowledge and direct access to our technology and development process. With that, our customers understand the viability of the project and its potential delivery earlier in the development program.

Customers also have complete visibility into our manufacturing process. That helps them identify design opportunities and constraints more quickly.

With the expedited timeline, customers are eliminating waiting time and moving their product to market faster. In addition, there’s overall cost reduction because development timeframes are shortened.

It’s a huge opportunity for our customers for so many reasons.

Fenske: Do the customer’s engineers or representatives need to be on-site to participate in the live prototype iteration process? Is there a remote element to this process?

Graham: Although we have had customer project teams onsite from as far as the West Coast of the United States and New Zealand, we acknowledge that travel to sites in the UK or Korea is not always viable. The first runs of XLerator were remote, and we still offer that option.

In fact, the especially restrictive COVID lockdowns were actually our busiest period for XLerator programs. They were all carried out remotely, and the design iterations worked equally well.

Customers are welcome to try out the remote service first as a trial. Video and sharing technology provide the opportunity to get very positive results. But we do find engineers often prefer to be face-to-face with the support team and the technology.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Graham: Although our brand identity recently changed, the XLerator service name will likely be retained. It is recognized in the market and very clearly defines what it brings to the device engineer’s project. We look forward to hosting many more of your readers.

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