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Industry Q&A: Common Pitfalls of Orthopedic Robotic Assisted Surgery Product Launches 

Robotic assisted surgery products were already on the ascent in the orthopedic space well before COVID-19, but the pandemic may just prove to be a booster for their continued adoption and growth.

Stryker’s acquisition of Mako Surgical in 2013 paved the way for it to capture significant market share, and other top-five orthopedic OEMs soon answered with development of their own robotic surgery platforms. With a shift in some procedures toward outpatient and growing notice from orthopedic surgeons, an “arm’s race” for robotic surgery was officially underway. Projections from Research and Markets pegged the North American market’s CAGR as high as 12.9% for the forecast period of 2017 to 2026.

The pandemic’s onset in early 2020 may ultimately have accelerated adoption of robotic surgery platforms, as urgency to curb exposure and decrease patient and provider risk pushed healthcare settings to adopt contactless robotic surgery. New possibilities for using robotic aids opened up, including monitoring vital signs, providing comfort care, and performing minor surgeries. These are, of course, in addition to the growing number of orthopedic procedures performed through robotic assisted surgery systems.

Robotic assisted surgery products introduce new complexities for OEMs and their supply chain and outsourcing partners. With this growing market in mind, Millstone Medical Outsourcing’s Marketing Manager Brittany Arnone talked with General Manager Tom Williams about what OEMs need to know when it comes to expert support for robotic assisted surgery product launches.

BA: What are some of the particular challenges and complexities of robotic assisted surgery platforms?

TW: There are a few key challenges facing OEMs when it comes to designing and launching robotic assisted surgery platforms—and this is where working with orthopedic robots differs from other orthopedic device products. In traditional orthopedic surgery, a surgeon uses implants and hand tools, instruments selected for the size of the device, patient, and so forth.

With orthopedic robot systems, you have another layer: now it’s surgeon, robot and implantable device. There are additional items that a robotic system requires so that the surgeon can perform successful surgery. These are components like screws and pins, and the majority of these are sterile, single-use items, which require a different approach to kitting and assembly.

In addition, robots introduce a new and specific kind of complexity. Precision in the robot drives precision in everything else. There are tight critical to quality tolerances to meet, for example, and as an expert outsourcing partner, we’ve had to develop programs for these challenging dimensional inspections.

It’s important to realize that investments in these robots can be upward of $1 million or more, but performance can hinge on an item that might cost $100 or less. If a component doesn’t work, the robot is useless until this can be corrected. As a partner for these complex product launches, we really never lose sight of the fact that the whole is greater than the sum of its parts. Success takes expert management of every detail, from supply chain through packaging, to support patient outcomes, surgeons and cases, and revenue generation.

BA: You mentioned challenges of kitting and assembly. What are the keys to success?

TW: I mentioned that there are more components like screws and pins that go into robotic assisted surgery product kitting. The more kitting and assembly your process involves, the more vendors you add, and the more complexity you introduce into the supply chain. It can be extraordinarily difficult to pull everything together at the right time. Everything from components to packaging materials has to align at the right moment. If one slips, they all slip. So, ultimately, the key to success is having a partner who is focused on the overall supply chain, not just any single piece. This can bring together these separate pieces and smooth out any bumps or delays in the process.

BA: What about packaging and package validation, which can already be a challenge for traditional devices?

TW: Packaging and assembly validations can be extremely challenging—and this is often where OEMs can run into problems during product launches. As experts in package validations, we always encourage OEMs to consider product and package design as two halves of a single whole—and this is no different for robotic assisted surgery products.

Packaging and assembly validation has to be built into the entire product launch timeline so that it doesn’t become a mad scramble at the end. This is especially true for new products like many of these orthopedic robots. I’ve always said that new products introduce new challenges.

In addition, there are new considerations for cost-efficiency in packaging. The traditional orthopedic devices are kitted with instruments in surgical trays. A high volume of single-use disposable items can drive up packaging costs dramatically.

BA: What are the most common pitfalls of product launches for robotic assisted surgery products?

TW: While I’ve touched on it already, it’s worth repeating: the most common mistake is not addressing the requirements of packaging and assembly validations early enough. By “early enough” I mean from the product inception stage.

The other thing that comes to mind is failing to outsource for critical expertise. OEMs should be ultrafocused on the robot itself. A true industry expert can—and should—handle the rest.

BA: What should an OEM look for in an expert outsourcing partner?

TW: The word “partner” gets thrown around a lot—but partnering with the right group, even in the development stage of the product, is essential. The right partner will be able to get granular on what the entire launch timeline needs to be so there’s no scrambling at the end.

In the end, there are so many items that we’re packaging or assembling that are mission-critical for making the robot work. I’m not saying this to downplay the complexity of traditional implants by any means, just that there are details and items to manage that affect whether or not these precise and high-investment robots will work. It’s absolutely critical that OEMs work with a partner that has experience in robotic assisted surgery products.

BA: What are some symptoms that might indicate trouble for an OEM with an upcoming product launch?

TW: These are familiar symptoms to anyone working with the complexity we see every day in orthopedics: always running behind, slipping timelines, supply chain delays for newly manufactured parts, failing CTQs, assembly schedules that fall apart because you’re waiting on a component. This all comes from not thinking holistically from the very beginning about every step being part of a streamlined supply chain, driven by an expert partner through every part of the process.

At Millstone, we understand the challenges OEMs face in the robotic assisted surgery products market. We have successfully launched and supported packaging for four major orthopedic robot platforms and bring a birds-eye view of the growing robotic assisted surgery products market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at https://millstonemedical.com.