As the spinal fusion market continues its shift toward minimally invasive surgeries, it has created a multitude of challenges for delivering graft to the surgical site. An example is the development and use of expandable cages. While the expandable cage is a significant step forward, it can limit a surgeon’s ability to pre-fill the cage with bone graft prior to placement. As a result, design and production of a new generation of bone-graft delivery systems are underway.

Suppliers and device manufacturers are developing new bone-graft funnels, syringes, and cannulas to meet this growing demand. To rapidly respond, however, a supplier and device manufacturer must work together to overcome a number of internal and external challenges. On the internal side, it’s fostering a partnership—not just a relationship. They must conduct research, ask questions, create prototypes, get feedback, make updates, and repeat the process multiple times before launch. External issues include a medical industry that demands innovative products in a short timeframe and surgeons’ desires for custom solutions.

The Need for Speed
While traditional spinal fusion procedures have been the norm, minimally invasive surgeries are on the rise. A 2014 article in Becker’s Spine Review noted, “More spine surgeons are moving toward minimally invasive techniques. Residents and fellows continue to learn the open procedures first and then focus on less-invasive techniques.”

Today’s bone-graft delivery devices are used in a number of surgeries, including spinal fusions, dental implants, joint replacements, shoulder surgeries, and repairs of broken bones.

An executive at an orthopedic device manufacturing firm said developing bone-graft delivery tools for minimally invasive surgeries is a fast-growing portion of the company’s work. “With smaller access to the injury area, doctors need accessories that deliver the bone-graft material and, at the same time, pack it in. With all of our bone-graft devices, surgery always is top of mind.”

Spinal fusions are the most common spine procedure and are expected to hold that spot for years. They are performed using the traditional “open” technique or as a minimally invasive procedure. For the latter, the surgeon inserts a tubular retractor through a tiny incision to the spinal column. The devices delivering bone-graft material must be designed to fit through the retractor’s small tunnel, which is vastly different from the larger space available during conventional open fusions.

Then and Now
Bone-graft devices have come a long way from those used during the first bone-graft surgery. In 1668, Dutch surgeon Jacob van Meekeren successfully grafted a fragment of a dog’s skull into the skull of an injured soldier.

Today’s bone-graft delivery devices are produced by three suppliers that each partner with a device manufacturer to bring products to market. The devices distribute three types of bone-graft material:

• Allograft (bone from the patient)
• Autograft (bone from a donor)
• Synthetic bone graft substitutes

When performing bone grafts, surgeons will most likely use one or a combination of the following delivery devices (Figures 1-3):

• Bone Funnel: Bone-graft material is poured into the device and mixed with such fluids as blood, plasma, and bone marrow. A plunger then pushes material into the target area.
• Syringe: First filled with dry bone-graft material, then mixed with blood, plasma, bone marrow, or other hydration fluid. The mixed bone-graft material is pushed through a short tube (cannula).
• Cannula: Thin tube attached to a syringe that enables targeted placement of material; lengths range from 5 cm to 20 cm depending on the bone-graft location (back, hip, shoulder, knee, etc.).

The devices (especially funnels) can be stainless steel and require sterilization. The plastic, single-use disposable system (usually syringes with cannulas) are already sterilized and can be used immediately off the shelf. Ideally, these systems come prefilled with the graft to reduce set-up time in the operating room and eliminate waste.

When speaking with doctors and healthcare professionals, the orthopedic device manufacturing executive said clinicians ask about cannula diameters and lengths, whether or not the system can handle high-viscosity and granular material, the curvature of the device since the access port may be different from where the injury is, and if it’s bendable.

Customization
If needed, the surgeon or scrub tech will trim the length of the cannula—often in the operating room—to tailor the device for a particular need.

“Ideally, the doctor or scrub tech has been taught how to use the device by a trained sales rep before being used in a surgery,” said the executive. “But there are a few doctors who believe training isn’t needed. I’ve actually received calls from the surgery room with questions.”

These types of situations can be overcome by a supplier that customizes bone-graft delivery tools for its device-manufacturing partner. “Customizing the length and diameter of cannulas is what our supplier does,” he said. “Design and production isn’t our core competency. So we outsource such needs to our supplier. We then provide those customized solutions to our customers, which saves them precious time in surgery.”

Partnerships Reign
How fast a device manufacturer and its supplier respond to medical advances is critical, especially with the rapid rise of minimally invasive spinal surgeries and expandable cages. The key to fast, revenue-producing results is the association between a device manufacturer and its supplier. At the highest level, the companies must provide safe, premier-quality devices that lower burdens on the healthcare system and drive down healthcare costs. Today, a transactional relationship between a supplier and manufacturer isn’t enough. It has to be a partnership where trust and transparency rule.

Before hiring a partner, however, a device manufacturer must thoroughly vet the supplier. Characteristics of top-notch suppliers include:

• FDA registered facility
• ISO 13485 registered facility
• Class 8 certified cleanroom manufacturing and assembly
• Industrial design
• In-house testing
• Design for manufacturability and assembly
• On-site regulatory and testing support, including design history file
• Ability to customize and/or private label devices
• Sterilization (EtO and gamma stable for pre-fill)

To achieve a strong partnership, engineering and R&D at both companies must strategize, be diligent about cross-communication and upfront about expectations, and integrate systems.

To create platforms for future delivery systems, a supplier and its device-manufacturing partner must ask the same question doctors ask patients, “What hurts?” To discover pain points with bone-graft delivery systems, the partners attend conferences where surgeons present challenges they’ve experienced, hold focus groups with clinicians, have sales representatives gather feedback from surgeons, and meet regularly with key opinion leaders who monitor device trends.

Once the team maps out a new or updated product, the supplier develops prototypes. “There’s a lot of back-and-forth through regular meetings, on-site visits, and 3D modeling by the supplier, which has tremendously sped up the process,” said the device manufacturing executive.

With a prototype in hand, the suppliers and device manufacturers secure feedback from users, update the design if needed, get more feedback, and then produce an actual product to test, retest, and test again. Throughout the process, the supplier’s in-house regulatory compliance experts work to ensure the device meets with U.S. Food and Drug Administration (FDA) guidelines.

Securing FDA approval can be time consuming, which slows a manufacturer’s ability to launch new products. A 2015 study by Harvard University confirmed this. “For most devices, the evaluation criteria that the FDA will use to assess a new product are not made explicit before the regulatory process begins.” The study found the lack of specificity about data to gather and present to regulators, “makes the regulatory process for devices far more uncertain than that of drugs.”

The device-manufacturer executive noted, “For devices that are changed, it can take six to nine months of design and development to get the final prototype ready for the FDA. Then once we get approval, it can take another nine to 12 months to produce and get to market.” For new products, the timeframe is even longer.

A 2016 study of medical device professionals by Axendia, a medtech consultancy firm, found 62 percent of respondents identified “regulatory, government agencies” as the top business disruptor. “Generally, when regulatory or government agencies ask for information, there is a tremendous disruption to the business. It’s all hands on deck to ‘manage’ the inspection, gather requested information, and respond to inquiries.”

To help speed up the development process and regulatory abyss for medtech companies, including suppliers and manufacturers of bone-graft delivery devices, Axendia discovered that some medtech firms institute “closed loop” change and configuration processes. The methods drive product improvements and accelerate new product introductions, while at the same time supporting regulatory compliance.

Using analytics and connected systems, suppliers and device manufacturers receive timely feedback and continuous improvement across a product’s lifecycle. The process evaluates and justifies potential changes to improve metrics such as performance, quality, and effectiveness, and to help avoid regulatory problems before they occur.

“For data to have value, and yield actionable intelligence, the underlying structure must be actively managed,” the report stated. “Useful data must be visible and supported across the entire product lifecycle, from R&D to manufacturing to patient and back.” 

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Ben Johnson, M.B.A., B.S., is a product and business development manager for Nordson Medical, where he is a principal in the areas of marketing, sales, engineering, R&D, and customer relations. From concept to commercialization, Johnson is involved throughout the product lifecycle for Nordson components, devices, and custom OEM solutions that precisely manage and deliver fluids and biomaterials.