Choosing an Innovative Third-Party Device Manufacturer—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

The pandemic brought with it supply chain disruptions that impacted companies in virtually every industry. In the medical field, device companies found themselves reacting to everything from facility closings to unprecedented material and component shortages. Many began to question the reliability of their established suppliers and vendors, while others, for the first time, began to explore the viability of using contract manufacturers.
 
Sojan Abraham, Director of Engineering of Argon Medical Custom Product Solutions, shared his perspectives on working in an environment where there is a growing demand for contract manufacturers who can help clients develop their next generation of innovative devices.
 
Sean Fenske: When it comes to innovation in medtech, in which specific areas, devices, or components do you expect to see major advances in the coming decade?
 
Sojan Abraham: In the past decades, remarkable advances have been made in medical device manufacturing, across virtually every product category. It’s safe to say that even greater strides will be made in the coming years.
 
One area that is particularly exciting to the team at Argon is cell therapy—transplanting human cells to replace or repair damaged tissue. This has direct implications for us and the audiences we serve. Our goal is to help usher in new possibilities with innovations in areas like catheter manufacturing and miniature devices.
 
In addition, we’ll continue to focus on finding ways to improve both the patient and physician experience by developing devices that support innovative cardiovascular and oncological procedures—two areas that, again, will be undergoing tremendous advances in the years ahead.
 
Fenske: Looking more at the current state of affairs, what are the leading factors driving innovation today?
 
Abraham: Of the many factors that have traditionally driven innovation, three in particular come into play today: patient safety, emerging diseases, and shifting preferences in surgical procedures.
 
In the first—patient safety—the desire for minimally invasive solutions is driving demand for a broad array of better, smaller, safer, and more innovative devices. In the markets we serve, it’s particularly prevalent among vascular- and bone-access devices.
 
Individual lifestyle and macro environmental factors are causing the growth of oncological and cardiovascular diseases. For these types of conditions, achieving an optimal outcome relies heavily on early detection. So, devices that make early detection easier, more effective, and more affordable will be met with interest.
 
As for changes in surgical procedures—well, this is a continual evolution, and the examples are many. One that comes to mind is using cryoablation to freeze and destroy cancerous cells or abnormal tissues. Device manufacturers who read trends like this correctly—or, better still, deliver innovative products that lead the way—will have a definite advantage.
 
Fenske: How do clients—and the medical device industry at large—strike a balance between cost and innovation?
 
Abraham: In healthcare, balancing cost and quality has always been an issue. The rise of value-based care and other factors have made striking this balance a top priority for device manufacturers.
 
As a third-party manufacturer, there are several things we do to help achieve this. Improved simulation and lab testing can reduce costs and improve success rates. Rapid prototyping also helps drive down costs by reducing development time.
 
In addition, never underestimate the value of making fast, solid, incremental improvements, rather than depending too heavily on a radical “perfect solution” that might not materialize—or may take years and years to develop and approve. Both approaches can take you to the same destination; it’s just a matter of evolution versus revolution.
 
Fenske: Based on your experience, what are the biggest “pain points” that lead clients to seek out new suppliers and service providers?
 
Abraham: It’s no secret that recent conditions have resulted in tremendous obstacles for practically anyone involved in manufacturing.
 
Clients have always had natural concerns about the ability of suppliers and outsource partners to deliver and perform as promised; the supply chain problems magnified those concerns. At Argon, the fact that we have facilities here in the U.S. gives us a distinct advantage over competitors who do most or all of their manufacturing overseas, or who may be more dependent on an international supply chain.
 
Lead time is another factor. Clients are feeling the pressure to do more with less, and to perform more quickly. For many, examining outside options can be a way to meet challenges in those areas.
 
Also, a growing number of clients are looking for a partner who can do more than simply execute or produce to specification. They want someone who can take an active role in helping them create, develop, and design innovative devices and solutions, as well as provide more efficient manufacturing processes.
 
Fenske: Having worked with client product development teams, what best practices would you recommend to ensure a successful engagement?
 
Abraham: So many pieces of the puzzle have to be in place for a really successful engagement. So many facets, big and small. If I had to narrow down the most important things, it would be the fundamentals: fully understanding the needs of the end user. Scoping the project correctly from the outset. Keeping communication channels open throughout the engagement. And making a 110% commitment to being responsive to clients.
 
Beyond that, it’s also ensuring you have solid, proven processes in place. At Argon, we’ve been involved with literally hundreds of projects, and we’ve learned a lot along the way. We’ve done our best to isolate best practices in design, development, and manufacturing, and incorporate them into every engagement.
 
 Fenske: What recommendations would you make for clients who are considering using a third-party developer or manufacturer for the first time?
 
Abraham: Going with a contract manufacturer for the first time is a big step for most companies. There are several things they need to examine closely.
 
First, be certain their engineering team is first-rate. That means they not only have strong technical skills, but are also committed to doing what it takes to achieve project deadlines and deliver successful devices.
 
Also, make sure the company itself has a proven reputation in key areas like product development, R&D, and regulatory support, as well as a strong quality management system. A vertically integrated contract manufacturer like Argon can not only provide this, but also provides end-to-end capabilities that can help you realize greater efficiencies along the way.
 
And the final piece of advice I’d give is to view your contract manufacturer as more of a partner than a vendor. Yes, they work for you. But also take a close look at what they can bring to the table to enhance the process—like helping you evaluate and navigate material selection, expedite design and testing processes, and finding areas where their specific experience might add to the overall success of both the device and your working relationship.
 
Headquartered in Plano, Texas, Argon Medical is a leading global manufacturer of specialty medical devices for interventional radiology, vascular surgery, interventional cardiology, and oncology. Click here to find out more about Argon Medical Custom Product Services.