New Product Introductions and Manufacturing Transfers—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief
 
New product introductions are a challenge for any OEM, but having a manufacturing transfer involved can increase the degree of difficulty. As such, its critical to identify the right partner who is familiar with the most common pain points associated with both protocols.
 
Medical device OEMs need to ensure there are clear lines of communication, the planning is comprehensive and fully understood prior to any action being taken, and tasks are designated ahead of time, such as testing. As a partner in the process, any contract manufacturer of quality must be in lock step with this strategy and put forth effort to help ensure these goals. Without the OEM and contract manufacturer on the same page, any project is doomed to fail.
 
With this in mind, MPO spoke with Andy Reding, chief commercial officer, and Sean Crowley, COO, from Viant to gain insight into how they go about ensuring a successful new product introduction and manufacturing transfer. In this Q&A, Reding and Crowley offer best practices for both processes, how their company approaches each with customers, and the factors to consider that could derail the project.
 
Sean Fenske: How does Viant approach new product introductions and manufacturing transfers?
 
Andy Reding: ViaLaunch is Viant’s NPI and manufacturing transfer process. Our first step, which we call ViaLaunch kickoff, allows us to align with customers and lay the foundation to operate as one team.
 
We have a vision of being the industry’s most trusted partner so it’s critical we understand the unique objectives of each program and put ourselves in the shoes of our customer—the business owner—who is responsible for bringing these life-impacting products to market.
 
We collaborate to leverage the collective experience of both our team and the customer’s team to proactively identify risk, address real-world issues that could cause delays, and track concrete actions.
 
We utilize the ViaLaunch process to navigate to a successful launch. ViaLaunch is built on the foundational Project Management Institute process but we’ve added enhancements to provide a better customer experience, including greater visibility and control, and ultimately, better results. The elements include:
 

• Scope
• Budget/cost
• Time/schedule
• Quality
• Resources
• Risk
• Customer satisfaction
• Communication
• Enterprise alignment
• Standardization

 
Like any process, it’s only as good as the people that power it and our team not only has great depth and breadth of experience, but also live our “Own It” value—acting as a catalyst for the process with a focus on proactive, solutions-focused communication. It’s all about achieving our shared goal of delivering the project on time, on budget, and at the highest quality.
 
Fenske: What are the most common challenges companies face with new product introductions? How does Viant help resolve them?
 
Reding: Every company is looking for the on-time, on-budget product performance that’s in their business plan. Beyond that, many programs have unique aspects such as compressed time to market (some faster than others), reduced cost, or novel function that can present challenges.
 
Speed to market is critical and attaining it is a core focus of ours with our team developing a comprehensive resource plan that identifies key responsibilities by individuals, from our partner and the Viant team, to ensure our staffing is appropriate to execute the project expeditiously. At times, customers have a need to accelerate beyond the initial project plan, and we can add resources to accelerate the timeline. Our Production Preparation Process (3P) can also accelerate timelines.
 
Another common challenge is late-stage changes that impact cost and timing. Once a manufacturing process is fabricated and built, it becomes extremely expensive to make a change, including re-machining parts, re-installing, re-validating, etc. It’s much more cost effective to make changes on the front end, when we can easily modify the design in CAD. In this case, a change takes minutes rather than weeks or even months.
 
Viant mitigates this risk using tools like Design for Manufacturability (DFM) and our 3P process.
 
 
Fenske: What role does Design for Manufacturability (DFM) have in the NPI and manufacturing transfer processes?
 
Sean Crowley: DFM plays a critical role. The best idea in the world can’t help a patient if it can’t be manufactured. We have deep experience in DFM/DFA/DFX, including more than 50 years of experience in our core markets and applications, with hundreds of projects successfully launched. Our cross-functional teams implement design for excellence best practices to ensure a smooth development path and consistent, high-quality product manufacturing.
 
For example, an endovascular device startup engaged Viant on an extremely complex, novel balloon catheter that many in our space said couldn’t be done. The customer needed DFM help for improved clinical results and improved production yield (then at 35 percent). We partnered with the customer through design iterations to achieve an FDA-approved product with proven superior clinical efficacy and a greatly improved 97 percent production yield.
 
Fenske: How does Viant use the Production Preparation Process (3P)?
 
Crowley: We use 3P as a front-end process design tool to mitigate risks and minimize waste in launches of both manufacturing transfers and new products. 3P delivers speed-to-market, assured quality, optimized costs, and efficient CapEx, as well as aligned and collaborative stakeholders. Core building blocks include cross-functional involvement, understanding the customer’s definition of value, a proven method of generating breakthrough concepts, and a culture that embraces Lean Enterprise.
 
For example, Viant held a 3P event with a small startup that had an energy-based device. Four teams worked independently, then collaborated to mock up and simulate production on a 20-station lean assembly cell. As a result of 3P, the team was able to decrease cycle time by 10 percent of the quoted target, balance the line within ±4 percent, decrease net labor by 48 percent of quoted target, and achieve necessary capacity with no additional CapEx.


Fenske: Can working with a contract manufacturer (CM) add to the complexities of NPI if they aren’t involved early enough in the process?
 
Reding: Involving a CM upfront leverages the breadth and depth of expertise that can minimize changes that typically occur without their involvement. At the same time, if you’re working with a CM later in the process, we recommend choosing a partner with the right expertise to quickly solve problems as they occur. At Viant, our engineers are trained on root cause analysis and Lean production techniques. Combining that with our extensive device experience and capabilities set enables us to rapidly solve problems.
 
For example, a large orthopedic company obtained a line of arthroscopic shavers and burrs through an acquisition. The line was marred by inconsistent field performance, an incomplete design history file (DHF), and an unstable supply chain. Viant successfully transferred product manufacturing using facilities in the U.S. and low-cost geographies. The team used root-cause analysis to quickly diagnose the problem. Team members redesigned the product for improved performance, improved the manufacturing line, stabilized the supply chain, and launched new devices, for a total of 50+ codes with an updated DHF. These efforts led to an 80 percent decrease in COGS, more reliable device performance, reduced customer complaints, and solid yearly volume growth.
 
Fenske: What are the most important things to consider before a manufacturing transfer?
 
Crowley: You have to understand the current state of both the manufacturing process—including the supply chain—and the device performance. You also have to understand how market guidelines may have changed since the product was first introduced. This might come into play if you acquire a product line that needs to be brought into compliance, for example. Our manufacturing transfer process includes getting a baseline in these areas to ensure we don’t encounter delays when decisions are made to optimize from the current state.
 
A manufacturing transfer is also an opportunity to optimize manufacturing. We can leverage 3P to take cost and complexity out of the product.
 
For example, a global medical device OEM engaged Viant to transfer a complex, minimally invasive surgical device. The timeline became increasingly aggressive due to supply issues. Six months later, the customer added a second device to launch in parallel with the first.
 
Using the ViaLaunch process, Viant leveraged 3P events to cut labor by 50 percent and incorporate the second device within the same launch date. The team was also able to shave three months off the timeline by increasing resources and adjusting the scope. Collaboration, trust, and proactive, transparent communication were keys to success.
 
Results included a 50 percent reduction in labor, eliminating the need for an additional assembly line, and launching the second device in parallel with first. The customer is now partnering with Viant on additional projects.
 
Another critical area is planning and communication, including contingency planning. You need to be in tight alignment with the customer; they’re making decisions to shut down a line and we’re essentially playing with live ammo. There is virtually no margin for error and our team executes our ViaLaunch process to drive collaboration, and ultimately, success.
 
Fenske: What are your best recommendations for ensuring a smooth process with both NPI and manufacturing transfer?
 
Crowley: The most important thing is to really plan the program before you start the work. Communication and process are key, but also flexibility and agility to adapt as needed. Leading the NPI and transfers with trained and experienced program managers with cross-functional, well-resourced teams that have the necessary project management tools, leadership support, and resources to overcome obstacles and achieve project plans is a cornerstone to ensure a smooth process.
 
Our ViaLaunch kickoff process begins with a team meeting with customers to align on key areas including:
 

• Scope and communication plan
• Quality systems
• Defining responsibilities
• Setting milestones and defining deliverables
• Budgets and cost considerations
• Understanding priorities

 
At Viant, our processes have evolved over hundreds of manufacturing transfers and new product introductions. Our culture of focusing on excellence and continuous improvement means we are continually enhancing and shaping our processes to ensure our capabilities can meet our customers’ growing needs for more—and more complex—NPIs and manufacturing transfers.

Learn more about Viant here >>>>>