Under Pressure: Innovating a Connected, Minimally Invasive Device

By Erich Stein, Technical Business Unit Manager, Nypro, A Jabil Company

Originally appeared on Jabil Blog

The connected healthcare market is estimated to reach $10,158.15 million by end of 2024, growing at a CAGR of around 27.47 percent between 2018 and 2024, according to Zion Market Research. In addition, MarketsandMarkets estimates that the minimally invasive device market will be worth $21.47 billion by 2021. Imagine the market value of enhancing minimally invasive devices with connectivity.

It is difficult to manufacture these devices to the quality standards required for Class III medical devices. That’s not to say it can’t be done. It means that healthcare manufacturers face new challenges and considerations during the product development cycle, leading to uncertainty in numerous areas. But through collaboration, we can innovate this market.

To explore the opportunity to create a connected minimally invasive device, specifically a smart heart catheter that measures blood pressure in the heart, Jabil’s Healthcare Division created a bold proof-of-concept they code-named “Project Under Pressure.”

Watch Jabil’s short documentary, Under Pressure, below.

The Challenges of Building a Connected Minimally Invasive Device

With catheters, the form is limited, defined and must be the right size to be effectively used in minimally invasive surgeries. Accessing the surgical environment through multiple bodily incisions dictates a target level of miniaturization that must be achieved for an effective procedure. As a Class III device, everything that goes into the body is high-risk, so there is a need for exceptional reliability to ensure nothing goes wrong during the procedure.

The manufacturing challenge lies with properly threading and soldering tiny wires to sensors within the catheter. Market research shows a very high scrap rate for these types of catheters, up to nearly 20 percent. The most concerning part is that these medical devices are typically scrapped after a lot of value has been invested into them. Of course, these are not unexpected challenges when working with more than 60 wires smaller than the diameter of human hair.

In other words, the product must be tiny, highly integrated and of the absolute highest quality. This is the manufacturing challenge that the healthcare industry struggles to address. But it is an area where close collaboration with partners can lead to successful solutions.

The value of reducing scrap within the manufacturing process goes well beyond the heart catheter. While the “Under Pressure” smart heart catheter primarily measures pressure within the heart, the concept for other connected catheters would involve similar work: miniaturized sensors, wire handling and connections.

Overall, there is enormous potential for adding sensors to catheters. Today, you can find some optical and pressure sensors integrated into similar products, but as sensors get smaller and procedures get more advanced, there are opportunities to do so much more. In fact, we believe in-body devices are the next frontier in healthcare. According to Jabil’s 2018 Connected Health Technology Trends survey, in-body devices are within the top priorities of healthcare manufacturers. Download the full Connected Health Technology Trends Report

In an industry where 95 percent of companies face manufacturing challenges and 98 percent report industry hurdles impacting the development of their connected health solutions, it is easy to get discouraged. After all, one in five connected health device manufacturers pull back their solution before launch or never make it to the market, according to Jabil’s survey.

This is the reason we brought together a global team across disciplines. The advantage of having multiple sectors and engineers involved in the project is that they tend to view problems differently. With projects like this, the value is in the people. Only through diverse perspectives can we overcome the many challenges healthcare manufacturers face in developing connected solutions.

Bringing Global Teams Together Toward One Goal: Innovation

In the effort to build a connected heart catheter, a variety of teams collaborated throughout the process, including advanced assembly, manufacturing technology and innovation, additive manufacturing, automation, software design and healthcare. While all teams lent valuable expertise to the project, one team made a big difference in the time it took to create device housing prototypes: additive manufacturing.

In a traditional manufacturing setting, the process of creating a plastic housing would be outsourced to a machining, tooling or injection molding company where dies would be created, and parts would be molded. It is also typical that the first three or four iterations would not be what the engineers want. Each of those iterations can take between two to five weeks, with a high price tag attached to it.

Through additive manufacturing, the team was able to bring the iteration time down to a day. Parts would be printed, the team would test it, make revisions and print the next version the next day. In addition, the team was able reduce the number of parts and cost to drive toward a single model.

Ultimately our mission here was to provide rapid prototyping for a medical device.

Healthcare Manufacturers Must Collaborate with Partners

Project Under Pressure may show how diversity can amplify the outcome of a project, but there is a lesson here for all healthcare manufacturers. Utilizing partners enables more and greater accomplishments. Since connected health currently lags other connected industries, companies have an opportunity to learn from more advanced groups that can bring new perspectives into healthcare.Participants from Jabil’s recent survey echo these sentiments: 99 percent of them say that partners will be important to push connected health solutions forward. Naturally, 65 percent expect manufacturing partners with expertise in connected devices will be important, 63 percent say technology partners with expertise in cloud, data and privacy will be key. These findings make sense, considering the hurdles healthcare manufacturers face, which I mentioned earlier.

When innovating medical devices, asking tough questions is paramount. Are you translating trends and environmental, technology and regulatory changes into actionable strategies? Have you defined the role your company and your supply chain aims to play in becoming a critical link for realization of right-sized, cost effective devices that have high impact on better patient outcomes? Finally, did you bring in diverse perspectives and capabilities together for the betterment of all? That’s where we started.