The man’s name is Robert, an active, healthy 70-year-old—except for one previous heart attack. He was lucky. Unlike millions of people who suffer heart attacks, he survived.

This brief yet shocking incident was captured on a CCTV video and the video was played during a session at the 3DEXPERIENCE Conference by Boston Scientific, the company that made the medical device that saved Robert.

Surviving a heart attack is remarkable and miraculous in itself, but what is even more remarkable is how Robert was saved using new innovations.

The Prevalence of Heart Attacks and Cardiac Arrests

Innovations are always in demand for treating cardiovascular diseases; heart attacks and cardiac arrests have long been a serious public health problem in the U.S. and worldwide.

In 2020, there are more than 19.1 million cardiovascular deaths globally, and the prevalence of coronary heart disease is increasing. In the same year, about 697,000 people in the United States died from heart disease in 2020, which is 1 in every 5 deaths—more than from cancer, COVID and accidents.

More than half of cardiovascular deaths occur suddenly. Deaths related to heart disease occur when patients have a heart attack or cardiac arrest outside of the hospital (pre-hospital setting) or in a hospital (in-hospital setting). The pre-hospital survival rate is much lower than the in-hospital survival rate, likely due to lower availability of medical equipment and personnel. In addition, out-of-hospital cardiac arrests occur more frequently than in-hospital ones, making their treatment even more challenging.

Due to the sudden nature of a cardiac arrest, its optimal treatment needs to happen within an hour after the onset of symptoms (also known as “the golden hour”). For example, the “door-to-balloon” time, which refers to the timeframe within which a procedure called angioplasty needs to be performed to stretch open a narrowed or blocked artery, is 90 minutes.

The patient needs to be discovered by somebody who can correctly diagnose his or her condition or recognize the severity of the situation. Then, first-aid such as cardiopulmonary resuscitation (CPR) or treatment with an automated external defibrillator (AED) needs to be administered. Next, the patient needs to be transported to a hospital promptly and treated by a doctor in the emergency room within an hour.

A delay in any or several of these steps will subtract from the golden hour.

While CPR improves the survival rate of patients undergoing out-of-hospital cardiac arrests, it works best for the first 20 minutes; beyond that window of opportunity it becomes much less effective. In addition, the frequency of bystanders performing CPR (10 – 65 percent) and resultant survival (3 – 22 percent) in the United States varies significantly due to socioeconomic and demographic factors, to the disadvantage of low-income and minority communities.

In addition, while AEDs are life-saving and can achieve a 95 percent success rate, they are hard for a person to carry around. Therefore, they are often set up at home or installed in public spaces. Occupational Health and Safety Administration estimated that 30 million are needed to cover 70 percent of the population, which lives in urbanized areas and another 10 million to cover the population living in non-urbanized areas. However, only about 4.5 million AEDs are in use. As a result, AEDs are rarely used by bystanders to treat cardiac arrests.

There are other technologies that can help reduce the occurrence of cardiac arrests. For example, pacemakers are small, implanted devices which can help prevent cardiovascular abnormalities by regulating heart rhythm with emitted electrical pulses.

Another example is telemetry, in which dedicated personnel collect and monitor measurements from patients and identify ones who are having issues. But telemetry is more applicable for patients who have cardiac arrests in a hospital.

Taken together, most preventive technologies cannot be used to treat cardiac arrest when it happens outside of a healthcare facility and there is a need for technologies that can address one or several of the bottlenecks in the process of identifying, triaging, transporting and treating patients who suffer heart attacks while out in the world.

How VIGILANT Works

VIGILANT, the device made by Boston Scientific that saved Robert’s life in the video, is an example of a class of disruptive devices called cardiac resynchronization therapy defibrillator (CRT-D), which can address several of these pain points.

A CRT-D is similar to an implantable cardioverter-defibrillator (ICD), an electrical device that constantly monitors a patient’s heart rhythm to detect and stop irregular heartbeats. ICD shocks the heart if it senses a dangerous heart rhythm. However, CRT-D differs from ICDs in that it has an additional lead (ICDs have two leads) passed through a vein traveling behind the heart to pace the heart from the left-hand side, helping the heart’s lower chambers—the ventricles—work in tandem. As a result, CRT-Ds increase the effectiveness of a diseased heart and elevate blood flow, thus improving heart failure symptoms like fatigue, shortness of breath and exercise intolerance, and reducing the patient’s risk of dying due to cardiac events.

Also, patients with ICD are at risk of electrical storm occurrences that are associated with mortality and poor quality of life. CRT-D minimizes the number of inappropriate ICD shocks, lowering the risk of electrical storms and the risk of mortality, and improving a patient’s quality of life. Moreover, CRT-Ds have a longer battery life than ICDs. For example, ICD batteries last around six years and the VIGILANT CRT-D’s battery lasts from 7 to 14.7 years. ICDs and CRT-Ds both require surgery to be implanted into patients, so a longer battery life will reduce the need and frequency for additional surgery and lower the cost of care.

In addition to longer battery life and improving heart failure symptoms, the VIGILANT device contains HeartLogic, a highly sensitive heart failure diagnostic technology that provides weeks of advanced notice and a low-alert burden for detecting early signs of worsening heart failure.

With the combined functionalities, the VIGILANT device circumvents the many bottlenecks in the process of treating patients having a heart attack. The patient no longer depends on being found and diagnosed by a passerby, whether the passerby knows how to administer CPR properly or can find an AED nearby and operate it, or call for an ambulance so the patient can reach the emergency room in time for treatment. The patient can be diagnosed by the HeartLogic function and administered appropriate electric pulses on the spot.

In Robert’s video, there were only ten seconds between his collapse and the activation of the VIGILANT device to deliver electrical pulses to his heart. The time of detection, diagnosis and treatment has shrunk from tens of minutes to ten seconds. Because the resuscitation happened so quickly, Robert was able to not only get up and walk off in no time but also feel fine afterward.

He recalled, “Honestly, if I hadn’t known that I’d collapsed, I never would have thought anything happened…I felt completely normal.” After double-checking his health in the hospital, he has gone on to live his usual, active lifestyle. The effects of delayed treatment on health and well-being, prevalent in many patients suffering from a heart attack and who unfortunately did not receive treatment promptly, are nearly impossible to detect in Robert.

VIGILANT’s Downside

CRT-Ds, such as the VIGILANT device, are not without a downside.

Aside from having risks similar to those associated with implanted ICDs, such as infection at the implant site, swelling or bleeding, blood vessel damage, bleeding around the heart, blood leakage, collapsed lung and shifting of the device, the main issue for CRT-D is cost. On average, CRT-Ds are significantly more expensive, at more than $36,000, compared to ICDs which cost around $23,000. In addition, CRT-Ds are suitable only for a specific section of the population of patients with cardiovascular issues.

Moreover, while many more lives could be saved if defibrillators were implanted prophylactically in patients at increased risk of sudden death, one can argue that the cost of implanting CRT-Ds in a certain number of patients can be used to cover a much bigger potential patient population in a longer timeframe.

Conclusion

However, if we stop looking at disease in terms of populations and statistics and instead look at each patient as a person, we can see each implanted device is worth it.

It certainly is to Robert. “The VIGILANT CRT-D gives me peace of mind,” he said, “I feel confident working, going to the gym and exercising, knowing that my device works. It is very comforting.”

Every life saved also means a great deal to the people who develop life-saving technologies. As Matt Sheldov, the Senior R & D Manager at Boston Scientific, puts it, knowing the impact of VIGILANT on patients like Robert is an “emotional paycheck.”

Starting in sales, White worked for a start-up in Southern California until 2017. But after the company's founder failed to pay him for four months, he lost everything. White had to move his family—a wife and four kids—to Arizona to stay with his sister. He was working as a handyman and repairing air conditioners to make ends meet. He recalls the time as "nerve-wracking."

Nevertheless, he kept on learning more about machining from YouTube videos. White got his first machining order from Craigslist and filled that order in his garage using a Tormach milling machine he brought with him from California. That client is still with him today.

“We stayed with his sister for three weeks while our home was in escrow,” says White.

He then got more jobs, growing organically, and soon moved from his garage shop into a bigger shop space, and eventually growing into a business that employs two others and occupies 2,500 sq. ft. of manufacturing space with four machines.

Going from near-homeless to owning a shop that does close to a million dollars of business annually, in just over five years, took an interesting mix of strategies.

Trading Higher Production Costs for Time?

White first had to address a significant, if not the most significant, pain point of manufacturers who order parts from overseas facilities.

The model of off-shore manufacturing is based on trading time for lower production cost: you can get the goods more cheaply, but you have to wait for them.

American clients used to go overseas and order from manufacturers in China, Taiwan and the Philippines. It will take them six to eight weeks to get parts of unknown quality. If they find out the quality is not sufficiently high, they have to reorder and wait another eight weeks. Rinse and repeat.

But what if you trade higher production costs for time?

This is not an easy sell, and White's clients were also skeptical initially.

However, while China has long been the world's factory, it is predicted by the International Monetary Fund to run out of surplus, i.e., cheap, labor, between 2020 and 2025. In fact, it may have already been starting to feel the pinch as early as 2010. As a result, the wage costs in China's manufacturing sector nearly tripled between 2002 and 2009, and rose by   percent from 2009 to 2019 by the government’s own official estimate. In short, China's labor cost has increased by a factor of six from 2002 to 2019, so much so that it is twice as expensive as that of Mexico. Cost is also no longer the only determining factor. Other disadvantages of outsourcing to China include quality issues, counterfeit products, inconvenient inspection due to long distances and long wait times.

White's strategy on trading higher costs for time is based on his belief that "to succeed, you need to understand the technologies important to your clients." He understands that his clients require technologies that will help produce parts of high quality. So, he buys machining equipment that is as high quality as that used by overseas manufacturers. He also makes sure he uses the best and most up-to-date software: the SOLIDWORKS platform for design, and Autodesk Fusion 360 for programming.

So, when White produced high-quality parts on the same day without having his clients wait six to twelve weeks, they were delighted.

"I also try to reprogram the mindset of my clients," says White, "I tell them, if you use me, this is how I will help with your engineering department, your QC and your deadlines."

With his background as a machinist, White also provides free consulting on process improvement and "making the client's engineering department's job easier." As a result, "once my clients have gotten a taste of how high the quality is and how quickly they can get the delivery, they do not want to go back to waiting months."

White's clients stayed on; the increase in cost was no longer the central issue. They responded positively when White bought a mill-turn machine, which is even better than the machines used overseas and can make complex parts more quickly--though at a slightly higher cost. A client even ensured exclusivity and priority by paying for a machine designated for filling its orders in White's shop.

In the process, White has shifted the conversation from price to timeliness and quality.

The Importance of Timing

White's grit and resilience are remarkable and intentional or not, so was his timing. He started his business in 2017 when multiple factors worked in his favor. First, the reshoring movement, which started around 2010, was gaining momentum. In addition, the Tax Reform Act of 2017 lowered U.S. manufacturers' tax rates to 21 percent, lower than the worldwide average manufacturer's tax rate of 24 percent.

Moreover, there were the tariffs enacted during the Trump administration. The 301 China penalty tariffs on imports and the 232 tariffs on aluminum and steel have made imports more expensive, giving U.S. manufacturers a competitive edge in pricing. Furthermore, the many effects of the COVID-19 pandemic on the global supply chain have compressed the timeline for supply chain reorganization.

No wonder White's clients changed their minds—and they were not the only ones. According to the Kearney survey, in March 2021, 49 percent of 120 U.S. manufacturing executives agreed that the benefits of onshore production outweigh higher labor costs.

Doing What Others Don't Do

White also sees manufacturing differently from most machinists. "I never came from the manufacturing industry. I started in sales, where customer service is a big deal," White recalled. He had worked as a blackjack dealer, a car salesman and an auto wholesaler ("400 cars per month").

"I have lots of experience working with people, following up and closing deals," he says. He also has experience dealing with people overseas and people who are hard to negotiate with. An extrovert, White loves to learn about people and is much more comfortable dealing with people than many machine shop owners.

Providing good customer service is one of the reasons White offers free consulting, which is an effective way for him to secure larger orders and longer contracts. 

Once his clients have realized how nice it is to work with somebody who can make their lives easier, they stay on. Their working relationships have gotten so comfortable that now, deals are done via text messages and emails. White even acts as a middleman and helps clients find other reliable vendors and subcontractors. White has grown his business mostly by word of mouth and intends to continue doing so.

Conclusion

Going old-school as well as high-tech has worked out well for White. He places a greater emphasis on using the most up-to-date technology than many machine shops, takes customer service more seriously than many machinists and is a more knowledgeable machinist than many customer service people in manufacturing. All these attributes have placed him in a uniquely competitive position.

He also stresses the importance of being flexible. "You have to get with the times. Shops that don't want to change habits, get technology updates, get re-tooled or use software will not survive."

White also does parenting differently. His wife approached him about homeschooling their children, and initially he wasn’t in favor. However, as she presented data on how much time children spend in school, versus their actual time spent learning, there was a large gap due to class sizes and time spent maintaining order in the classroom setting. So, they chose to hire a teacher with a master’s degree in education who comes to their home twice a week and provides a fun and diverse learning environment with a tailored education for their two daughters. This approach allows them more time to pursue their own interests, just like when he was growing up and spending time in shop, woodworking and motocross. 

For example, White's daughter Saylor, who presented at the 3DEXPERIENCE Conference ("She can already do programming on SOLIDWORKS. How many 10-year-olds do you know that can do that?"), wants to become a commercial airline pilot. She is currently working on a letter to pitch the idea to the CEO of Southwest to create a scholarship for her to get flight education.  

Looks like strategizing runs in the family.