Joan Melendez: “One that looks at everything”

There are significant influences from medical device manufacturers. There are special interests, not focused on patient safety and more focused on their bottom line. When you have big manufacturers lobbying against regulations for patient safety, it makes our job difficult. As a part of my interview series with leaders in healthcare, I had the pleasure […]

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There are significant influences from medical device manufacturers. There are special interests, not focused on patient safety and more focused on their bottom line. When you have big manufacturers lobbying against regulations for patient safety, it makes our job difficult.

As a part of my interview series with leaders in healthcare, I had the pleasure to interview Joan Melendez.

Founder and President Joan Melendez leads the team at Xcelrate UDI. She is a passionate advocate for the safety of patients and for innovation in healthcare. Xcelrate UDI is a medical device barcode scanning solution that goes beyond compliance to improve patient safety at the point of care.

Thank you so much for doing this with us! Can you tell us a story about what brought you to this specific career path?

I’ve been a patient advocate for pretty much my whole adult life. My first job was as a teenager, working in a medical office. I saw the workflow of how a patient goes from their first booking with a doctor to an operating room and what comes after. It’s a complex process and one that is prone to error — a lot of which can be solved through innovative technology and processes.

Very early on, I could see how patients were literally dying because the surgeon wasn’t talking to the primary health care provider about a patient’s pre-existing conditions. This eventually led to my first company, working with a preventive medicine doctor, that helped to solve these problems — and today, to Xcelrate UDI. This passion for helping patients has been a strong through-line for my entire career in the healthcare sector.

Can you share the most interesting story that happened to you since you began leading your company?

The most exciting thing is just being in an operating room and seeing when the nurse takes one of our devices and scans it. In that moment, if I see the nurse takes away an item that has been recalled — you know you just saved somebody’s life. I’ve seen that happen more than once in real time.

It’s almost as exciting as anything else you can think of — seeing something that you helped to create to provide that kind of a result. For a patient advocate, it’s the best thing.

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

Early in my career, I made the unfortunate mistake of walking in during a surgery! I was so focused on the process of putting on the eye protection, mask, shoe coverings, gown, etc. I didn’t see they had begun already. (No contamination happened, fortunately). I really would have preferred not to be there! I learned my lesson to be hyper aware of what you’re doing.

What do you think makes your company stand out? Can you share a story?

We’re the first with this solution and the technology. We prevent the use of recalled or expired items, which is a problem that has caused the deaths of over 83,000 Americans in recent years, and millions injured. We’re talking billions in lawsuits and economic damage.

Our solution? We provide a nurse with the ability to scan something and in between 3 to 8 seconds, they’ve got the information they need to do their jobs and prevent these kinds of tragedies from happening.

We train the hospitals on the regulations — showing them why this is important. It’s a huge gap in the medical industry. We’re working with systems and platforms that the hospital purchases, dealing with healthcare facility staff who don’t understand the regulations requiring it. They don’t understand what’s driving it. We’re helping to educate our clients about the why this matters to you as a nurse and clinical staff member. That’s providing a great experience for those patients that they are servicing.

There are other companies in this space, but all the other apps force you into their documentation, which can potentially skirt regulations. We don’t do that.

I know the nurses’ workflow because I worked in an operating room. In that hospital, they didn’t have documentation built out for their surgery area. It was all on paper. I learned their surgical processes, sterilization, supply processes, etc. Actually, the nurse wouldn’t even talk to me until she could trust me to build something she could use.

We didn’t build the application to line our pockets. We built it because there was a huge workflow issue in the operating room that is causing patients to die. I’m not exaggerating. A simple example: patients can bleed to death from staplers that aren’t working right.

We’re using the federal regulations for barcode parsing — and we’re the only ones that are certified to do that. There are companies that might allow you to fill out 4 or 5 data fields… we do them all and make sure the device is registered with the FDA. We’re the only ones that do that.

What advice would you give to other healthcare leaders to help their team to thrive?

This is a values-based organization focused on patient safety, not just making a buck. We’re always about improving workflow, not creating our own workflow. Also, we listen. We want to know everything about what they need to do and how they are using our solution. How are people impacted?

Don’t start with a solution that you think has the latest, greatest technology. Start by identifying the actual problem. See how a solution would work. Then build it, using technology to solve the problem. And train your team to operate in this way, solving the problems that people actually need to be solved.

Ok, thank you for that. Let’s jump to the main focus of our interview. According to this study cited by Newsweek, the US healthcare system is ranked as the worst among high income nations. This seems shocking. Can you share with us 3–5 reasons why you think the US is ranked so poorly?

Data integrity! Data is not shared. That’s a huge problem. We specialize in medical devices — so getting that data is critical.

As well, though there is regulation, there is a lack of accountability. For instance, there are many regulations vendors have to cover. But with regard to patient care, there’s no oversight!

We see how this operates recently, with curfews in areas hard-hit by COVID-19. You can have a curfew, but if there’s no consequences for breaking it, people will break it all the time.

There are significant influences from medical device manufacturers. There are special interests, not focused on patient safety and more focused on their bottom line. When you have big manufacturers lobbying against regulations for patient safety, it makes our job difficult.

Finally, there’s a lag in supporting education for medical practitioners. You need access to ongoing education around technology, which is always advancing. That’s where we’re bridging the gap for clinicians and administrators. It’s why we’re helping them to understand the regulations — we work on that a lot with our existing clients.

You are a “healthcare insider”. If you had the power to make a change, can you share 5 changes that need to be made to improve the overall US healthcare system? Please share a story or example for each.

There’s so much we can do to transform healthcare. From our perspective, the use of a Unique Device Identifier (UDI) for medical devices is something long-overdue. We’re excited to help make that happen.

This includes the complex work of ensuring health professionals can parse the data and take action from discreet data elements. From a technical standpoint, the challenge is ensuring all fields are filled. We’re in favor of consolidating different databases that have different data on them — and in the meantime, using technology to consolidate what’s on every list already.

We also need to hold manufacturers accountable to make these changes.

The emergency regulations that have come in since the start of the pandemic haven’t been effective. Think of all the new PPE that they let into this country under those regulations — and so much of it had to be recalled.

This isn’t just a US healthcare problem. We need to ensure that data is shared globally, where it can impact patient health.

All new PPE that they let come into this country under emergency use regulations — list of recalls for Emergency Use Authorization (EUA) is all on the EUA website. But it’s not on the recall page for the FDA. There is so much bad information and no accountability.

On top of this, we have a major problem that recalls are all voluntary! We need more rigor around this.

Finally, I would put more effort into patient advocacy and education. Patients have no clue about what’s going into their body. They trust their doctor. They trust that the medical device being used in their surgery is the best of the best… Little do they know, there’s this underlying issue that so many recalled medical devices are in our operating rooms, right now. For patients to even know to ask the questions that would help them be proactive about their own health, it would be so helpful. We need to put more resources into this.

Ok, its very nice to suggest changes, but what concrete steps would have to be done to actually manifest these changes? What can a) individuals, b) corporations, c) communities and d) leaders do to help?

Individuals — eg. individual healthcare administrators — they need to be vocal. I personally have email exchanges frequently with the FDA with the arm responsible for hospital resource management, the Learning UDI community and other groups. I’m the co-chair on the taskforce for recall management.

I recently met with a senator about this, to discuss what can be done. But people have to be vocal and ask for change. We see the problems hospitals are having … and we’re an advocate in all areas. Making sure that the value-added risks are known is key. It’s hard to talk about solutions until the problems are well known.

I’m interested in the interplay between the general healthcare system and the mental health system. Right now, we have two parallel tracks, mental/behavioral health and general health. What are your thoughts about this status quo? What would you suggest to improve this?

I actually developed an app for mental health, focusing on integrating primary care for Sacramento County. This area of health is so underserved.

For instance, let’s say someone suddenly becomes depressed. The healthcare professional treating them might not know the change in status could be because they’re diabetic and now having thought pattern changes. The person treating their mental health doesn’t know this because they don’t have access to their medical record.

Or let’s say a patient has a medical device. It’s an implant leaking (eg. breast implant ruptured). What’s happening to her mental status? She’s suddenly being verbally abusive? There could be a connection, but we would not know. There’s no reporting.

By the same token, in the USA, we can’t put in a lot of the mental health questions we’d like to include into health records. There is literally no form section where we could put it. We need to promote interoperability between mental and physical health.

How would you define an “excellent healthcare provider”?

One that looks at everything… and I must say, I’ve known some excellent healthcare providers. I’m talking about a provider that deeply understands and complies with regulations, while keeping patients’ health and safety top of mind.

Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?

It’s by Winnie the Pooh. “Please tell me you’ll always remember you’re braver than you believe, stronger than you seem and smarter than you think.”

This comes up any day of the week. And I’m sure that’s not just true for me.

Are you working on any exciting new projects now? How do you think that will help people?

For us, the thing that’s super-exciting and a game changer is the UDI clearinghouse.

This is helping solve a big problem. Recalls happen, but the notification is not shared widely enough. We’ve seen a manufacturer put in a recall and the FDA does not post the recall for 100 days. That means the recalled device is still in use for months. In the meantime, patients are getting hurt. So, this is a huge issue.

UDI clearinghouse is a way for us to work with manufacturers to clean up the data so it’s discreet for FDA. We validate the manufacturers’ data, return devices to them and that way, we’re able to notify hospitals in real time that there’s a recall.

We’re charging subscriptions to manufacturers so we can provide it to hospitals for free.

The good news here that makes this innovation viable is that manufacturers have a vested interest in the UDI clearinghouse succeeding. Once they’ve identified a quality issue, their legal liability significantly decreases if they can immediately issue a recall. We can achieve patient safety and profitability for manufacturers through this clearing house.

What are your favorite books, podcasts, or resources that inspire you to be a better healthcare leader? Can you explain why you like them?

I tend to stay a lot within my industry. I like to look at the data. I recently read The Danger Within Us. Listened to many podcasts on recall issues. The Bleeding Edge on Netflix is great, too. It’s a documentary on the medical device industry and problems we’re trying to prevent.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger. 🙂

Awareness of the problem of medical devices that have been recalled. This is what the FDA was trying to do, when they first started talking about creating a UDI. The fact that there have been over 4 million breast implant recalls alone in recent years tells you all you need to know about how big of an issue this is.

For instance, everyone knows what a VIN number is on your car. They get the problem this solves. So, why isn’t that standard for medical devices?

Take the case of a marathon runner who goes in for a problem and the doctor says they need to get a new knee. But why is this person getting the device? Because of their level of activity? Or is it because the doctor is just familiar with this particular device system? Would a patient even know to ask that? This is another specific example of how awareness could affect an outcome.

In an ideal situation, you could see not just whether your doctor is certified, but that every device they use is safe. What if, when you went into a hospital, a sign says “We are UDI-certified: All devices are safe for use.” The only way we’ll get there is if patients demand it.

How can our readers follow you online?


IG: @xcelrateudi

FB: @xcelrateudi

LinkedIn: /xcelrateudi

Thank you so much for these insights! This was so inspiring!

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