5 Keys to an Innovation Mindset for the Development of Health Devices

Editor's Note: Take a look at our featured best practice, Design Thinking (225-slide PowerPoint presentation). [NOTE: Our Design Thinking presentation has been trusted by an array of prestigious organizations, including industry leaders such as Apple, MIT, NASA, Ford, Boeing, Fujitsu, Syngenta, Palo Alto Networks, and Mercer, to name just a few.] Design Thinking is [read more]

Also, if you are interested in becoming an expert on Innovation Management, take a look at Flevy's Innovation Management Frameworks offering here. This is a curated collection of best practice frameworks based on the thought leadership of leading consulting firms, academics, and recognized subject matter experts. By learning and applying these concepts, you can you stay ahead of the curve. Full details here.

* * * *

IVC filters are surgically implanted devices designed to prevent pulmonary embolism.

Thanks to advancements in medical technology, people now have access to health devices that ease the management of critical illnesses. One such health device is the inferior vena cava (IVC) filter—a small metal device placed in the IVC or the large vein in your abdomen that allows blood to flow from the lower body to the heart. IVC filters are used to prevent blood clots from reaching the lungs and causing a serious complication called a pulmonary embolism (PE).

Although they are designed to be permanent, IVC filters have the potential to break off and cause serious complications. When IVC filters break, they can move through the bloodstream and cause organ damage or even death. As such, it is important for patients who have IVC filters to be monitored closely by their doctors.

To avoid this, device manufacturers should remember a few pointers for the development of health devices like IVC filters. To help you on the road to innovative device design and functionality, here are five steps you would do well to follow.

1. Know Your Product

As mentioned earlier, IVC filters are devices that prevent blood clots from permeating the lungs. These small, umbrella-shaped devices are surgically inserted into the groin or neck to catch blood clots from the lower part of the body and prevent them from getting stuck in the lung’s arteries. IVC is often used to avoid PE for those with deep vein thrombosis (DVT), a condition wherein blood clots form in the veins due to sluggish blood flow. Once the clots enter the lungs, PE will most likely occur.

An IVC filter prevents this from happening by attaching to the IVC’s walls to trap stray blood clots. There are IVC filters designed for permanent use, but there are also optional or retrievable filters on the market. Generally, the US Food and Drug Administration (FDA) recommends filters be removed as soon as blood clot risks are eliminated or adequately treated.

2. Understand the Customer’s Needs

IVC filters are usually intended for people who are at high risk of DVT. These include people who have experienced deep vein injuries in their legs and those with restricted mobility such as the elderly, obese people, pregnant women, persons with locomotor disabilities, and those afflicted with cancer or stroke.

Perhaps to a lesser extent, people who frequently go on long-haul airplane trips may need IVC filters due to their lack of constant movement. But in addition to those with mobility problems, experts also recommend IVC filters for smokers who have weakened respiratory functions.

IVC filters trap blood clots to keep them from entering the lungs.

In some cases, doctors recommend using IVC filters along with anticoagulants or blood thinners like warfarin. As such, IVC filters would also be beneficial for people who need blood thinners such as those with a history of heart ailments.

3. Design for Manufacturability

Most IVC filters are conical in shape and have legs (long struts) that project out from the base and capture the blood clots. The filter also has a tip with a hook to support retrieval, as well as arms (short struts) to ensure optimal coverage and keep the filter in place. Surgeons can use either the femoral or jugular variant of the IVC filter depending on where they intend to implant the device.

The prototype-to-production cycle of IVC filter development generally abides by design for manufacturability (DFM) engineering practices. Simply put, this means that brands develop their products in a way that they can be easily and repeatedly manufactured. It’s also worth noting that the FDA classifies IVC filters as low-risk or Class II devices, thus allowing the manufacturers to undergo a fast-tracked clearance process.

4. Invest in Quality

When developing reliable IVC filters, it’s best to pay attention to trusted brands. In a 2016 study, researchers analyzed the products of eight IVC filter manufacturers, namely ALN, Denali, Celect, Gunther Tulip, Option, OptEase, Crux, and VenaTech Convertible Filter. The researchers analyzed the placement of the filters in 95-554 patients as part of the analysis. Research data shows that placement and retrieval were generally successful for all eight brands and fell within a 90-100 percent success rate.

For the ALN filter, there were only a few cases of filter migration, fracture, thrombosis, and PE. Similarly, the researchers found a few reported cases of fracture, penetration, tilt, or migration for OptEase filters. Denali, however, had no cases of migration, tilt, or fracture. Celect also had no reported cases of filter perforation and hemorrhage.

People with restricted mobility may need IVC filters to manage PE risks.

On the other hand, Gunther Tulip was only found to be less susceptible to embolization. Option had few reports of tilt and vena cava irregularity upon retrieval, but none “required intervention”. Despite having a DVT recurrence rate of 10.4 percent, Crux was not linked to cases of filter migration, tilt, fracture, and embolization. VenaTech, which has been FDA-approved for clinical use, was also not associated with cases of tilting, migration, and thrombosis.

5. Continuous Improvement

Based on the study, the eight IVC filter brands had common minor issues that involved filter tilting, PE and DVT side effects, fracture, and migration. That said, these manufacturers can still improve their products so that they don’t tilt, break apart, puncture body parts, get clogged with blood clots, or have any of their components travel to the heart and other organs. Complications due to faulty IVC filters have already resulted in lawsuits, which you can read more about in this link.

Needless to say, manufacturers must prioritize meticulous research and development, quality assurance, and testing to ensure that their products meet industry standards. Doing so is vital for introducing a product that can revolutionize the way we treat serious illnesses. But most importantly, taking good care in the design, manufacture, and assessment of devices like IVC filters can ensure a more peaceful life for the vulnerable and their families as well.

Want to Achieve Excellence in Innovation Management?

Gain the knowledge and develop the expertise to become an expert in Innovation Management. Our frameworks are based on the thought leadership of leading consulting firms, academics, and recognized subject matter experts. Click here for full details.

To be competitive and sustain growth, we need to constantly develop new products, services, processes, technologies, and business models. In other words, we need to constantly innovate.

Ironically, the more we grow, the harder it becomes to innovate. Large organizations tend to be far better executors than they are innovators. To effectively manage the Innovation process, we need to master both the art and science of Innovation. Only then can we leverage Innovation as a Competitive Advantage, instead of viewing Innovation as a potential disruptive threat.

Learn about our Innovation Management Best Practice Frameworks here.