The Benefits of Vertical Integration Under One Roof—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

Contract manufacturing is a vital aspect of the medical device development lifecycle, but it doesn’t encompass the entire chain of required events for a new product. Working with a capable supply partner that can extend their usefulness pre- and post-manufacturing improves the entire process and enhances the value of the service provider.

This industry shift has led to medtech OEMs seeking the assistance of CDMOs (contract development and manufacturing organizations) over CMOs (contract manufacturing organizations). The support provided in the early stages of design brings invaluable advantages to the OEM’s project, saving on costs and time to market.

To help explain more about this trend and how his company is a prime example of it, John Budreau, Director of New Business Development at PTI Engineered Plastics Inc., participated in the following Q&A. In this interview, Budreau offers insights on why a vertically integrated organization provides a compelling offering to medtech manufacturers and speaks to the specific benefits that can be realized.

Sean Fenske: Vertical integration in medical device manufacturing can involve different processes for companies. What does it encompass at PTI?

John Budreau: At PTI, we are a full-service injection molding company that supports early design engagement through finished assemblies. Our design support role can be concept development and exploration or a comprehensive DFM (design for manufacturing). With full design for manufacturing reports and feedback, we help our customers design the most robust injection molded parts for production. Design and engineering are critical areas of PTI’s expertise that our customers leverage at the beginning of a project.

In-house tooling is also a key differentiator, offering our customers many different tooling options to support their program needs. We maintain the ability to build a development mold for their design testing needs, or a bridge tool to support their market entry builds. Ultimately, our goal is to build a mold that meets the customer’s production needs, whether that is thousands of parts per year or hundreds of thousands of parts per year.

Having a technology-driven, highly automated injection molding operation allows PTI to excel at manufacturing complex components for our customers. Our process engineering team develops a robust routine, driven by scientific injection molding principles. The SIM process development ensures the highest quality systems regarding capability and repeatability in production.

Finally, the post-molding value-add is a key factor and capability for our medical device customers. From pad printing and laser marking to multiple forms of plastics welding and joining, we can perform most post-mold processes. We manufacture full assemblies and, depending on the product’s annual volumes, we can automate these processes.

Being vertically integrated allows PTI to handle everything in-house for a customer’s project.

Fenske: Why is it beneficial to have these services under one roof? What synergies are enjoyed versus working with different providers?

Budreau: The biggest benefit of having everything under one roof is that it allows PTI to engage our customer with a cross-functional team early in the product development process. In most cases, this takes place during the quoting phase, which gives our customers a high level of confidence that the project will be a success.

Whether it’s utilizing our mold designers to support DFM and DFA (design for assembly) or our process and manufacturing engineers to review complex part designs and assemblies, PTI has an entire team of experts ready to support you.

Our team is accustomed to working with hundreds of engineered resins to help with recommendations, suggestions, and, ultimately, process development. PTI also tries to involve a member of our program management team early in the process so they can understand the customer’s requirements and goals. Finally, our quality engineering team—all well-versed in medical device validations (IQ, OQ, and PQ)—will be actively involved.

Fenske: Do you have an example or success story where vertical integration offered a significant advantage over other options?

Budreau: Yes. We manufacture an endoscopy device that utilizes six plastic components that we built tools for in-house. One of those components is an overmolded handle that needed a metal stem as the insert. In fact, there are several components that go into this product assembly that we were able to outsource to tier suppliers. Laser marking and pad printing were used in different areas of this device for direction and identification. PTI also developed and built automated assembly equipment to load, build, and test this assembly in one station. With PTI managing the entire project and every aspect of the assembly, it simplified and streamlined this project.

Fenske: Given the breadth of services you offer under one roof, is it important for a customer to engage with you at the start of development, or can you assist at any point in the development/manufacturing process?

Budreau: We find customers truly benefit from early involvement. However, PTI can assist at any point in the project or process development. PTI can offer many examples of helping a customer reduce the number of molded parts or purchased components in a designed product. We have also helped customers develop better part designs for mold construction and production processing. In addition, we have been able to reduce the number of assembly steps or operations in many cases. We see hundreds of different part designs every year, so we are able to share that experience with our customers. Therefore, involving us early in model and drawing development ensures we are successful in manufacturing throughout the production life of the program.

Fenske: What aspect of working with a vertically integrated supply/manufacturing partner do you find is often misunderstood or simply wrong? How do you dispel these inaccuracies?

Budreau: This isn’t as much related to vertical integration, but when a customer decides to split a project between suppliers, we have found it ultimately slows the project down. Having the toolroom capacity to manage multi-part programs and complete the full assembly all under one roof can expedite the production development process dramatically.

Fenske: What factors should an OEM determine or consider before employing a vertically integrated partner like PTI? Do they have homework to complete before engaging the partner?

Budreau: The OEM would certainly need to determine how they are looking to build or manufacture their device. However, if they are looking for a partner to manufacture the entire device, they need to visit and qualify the right partner. That partner can definitely be PTI. We can be involved in the very early stages of a project, including helping with concept development. This could also include PTI helping the customer with homework.

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