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.
Where did the idea for Xcelrate UDI come from?
I’ve always been a patient advocate. That’s where my idea and passion for this company comes from.
I started out in my teens working in a medical office. I remained in that space. In my 20s, I became more aware of the number of patients dying in cases where a surgeon wasn’t talking to the primary health provider about pre-existing conditions. So, that market problem popped up for me very early on.
Fast-forward to 2013, I became more aware when the FDA was promoting the Unique Device identifier (UDI), a scannable barcode, on medical devices as a way to track medical devices and potentially recalled items..
When you’re looking at a medical device, when it’s in your hand, how do you know if it’s recalled? Is that device being tracked in the electronic health record (EHR)? All medical devices for Class II and Class III (primarily implantable devices) required UDI barcoding by 2018. Then you have expired items… Mistakes happen, how can you keep expired items from being used when they remain on the shelves?
It was time for us to create a solution. We know what’s in the barcode. We take that data and parse it into the EHR. Xcelrate UDI is the only 3rd-party application that does this and is certified by the ONC to do that. Our solution allows healthcare providers to capture the full UDI data for each item scanned, and leverage our workflow automation to parse the UDI data into the patients’ EHR in less than 5 seconds! We’re the first with this solution and the technology.
What does your typical day look like and how do you make it productive?
I’ve got team members across the US and now in other countries, so I tend to start working on East coast time – very early. I work a lot with my team, and at the moment we’re tackling some of the problems hospitals are having with certain manufacturers. An ongoing task that I have is overseeing the development team since we react to hospitals’ needs in real-time. We’re busy all the time.
How do I stay productive? By staying focused and I rely on my teammates. We use applications to help manage our days and sprints, and when we meet with clients we engage with them using those tools too. With one client we actually have 3 different projects, so using organizational apps is key to making sure we don’t drop the ball and the clients are always in the loop in real-time.
How do you bring ideas to life?
That’s exactly what our application is – an idea brought to life. I saw the problems in the operating room, looked at the requirements from the FDA and saw how the UDI could improve patient care. That’s how Xcelrate UDI was born. It’s about always trying to see what problems exist right now, and trying to fix the problems centered on patient care and optimal workflow.
For instance, we’re currently involved in a Value Added Risk evaluation of a new product line that’s being brought into a hospital. We ask different questions than the hospital would ask and bring an essential new perspective. When we looked at this device in particular, the instructions for use for patient care didn’t match the FDAs GUDID data on MR safety. MR Safety is a key review element by the Joint Commission. We try to bring clarity to these kinds of issues that arise.
We’re also very data driven. It’s one thing to have an idea, it’s another to understand what’s happening in an operating room, what are the regulations, who would potentially benefit from an idea? It’s important to us to make a lot of data based decisions.
I’ve surrounded myself with a strong and capable team of industry experts – those that work for the company and those that I lean on that have worked for the FDA and are part of the healthcare industry. They help inform and value-check some of our assumptions and ideas to make sure they are a viable solution for us to carry through.
The other thing we do is, we pilot. We follow scrum, we build, we test and then use all those insights to refine the processes.
What’s one trend that excites you?
From our perspective, the use of the Unique Device Identifier (UDI) for medical devices is something long-overdue. We’re excited to be part of this trend and bring it to life… and what it can mean in the future for all patient touching items.
The UDI could help in tracking and preventing the use of Recalled not only in medical devices but for tissue and mesh. A recent example of a major concern for us right now is PPE. PPE is considered a Class II medical device. Since Covid-19, a significant amount of PPE has infiltrated the US under Emergency Use Authorization regulations. We can show how UDI can help! The danger without a UDI is three fold. 1. The UDI regulation was not followed. UDI was not assigned to most EUA devices. 2. Recalls and manufacturers removed from the EUA program are not shown on the 9 FDA APIs (example, recall database, enforcement reports, openFDA). 3. EUA Recalls and Removals display only on the Emergency Use Authorization (EUA) website. Many of these recalled items or items removed from authorization still are on the market today, being sold on healthcare providers and therapy provider association websites. It’s not the users fault for not knowing… How do you know where to look?
I’m also excited about the pending shift of focus to patient advocacy and education.
Patients have no clue about what’s going into their body. They trust their doctor, the doctors trust the manufacturer. They trust that the medical device being used in their surgery is the best of the best. 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. Are you having a knee or hip replacement? Is your surgeon using the system because it’s best for your level of activity or because that’s the only one they use? Will the device contain metal? How will having an MRI be affected? Who will tell the medical professionals what implants I have if I get hospitalized when traveling? Patients need more information and so do the professionals working with implantable devices.
What is one habit of yours that makes you more productive as an entrepreneur?
I get up every day and make my bed. It really helps me set up the day to get things accomplished. I work off task lists to keep myself organized, and of course, I have a great team. Oh, and espresso!
What advice would you give your younger self?
Just keep going. I had an interesting upbringing. But you have to remember – there’s always going to be someone who’s in your corner, rooting for you.
Tell us something that’s true that almost nobody agrees with you on.
My principles drive a lot of my actions. One example of this is COVID. I call out the people who aren’t following the rules, who aren’t wearing masks or social distancing. It’s not necessarily about the rules, it’s about the personal safety and safety for others. It’s challenging for people who are more self-liberty driven. Not everyone agrees with this approach but it’s a strong value of mine.
As an entrepreneur, what is the one thing you do over and over and recommend everyone else do?
I’m always questioning myself, and relying on others. That’s one thing I would tell other people to do. Be open, and ask for help. Focus on value-checking.
A person who is introspective and has a sense of vulnerability makes them more amenable for feedback. Vulnerability and humility doesn’t make you wishy-washy, so don’t let that sway you. I’m always open to hearing from others and asking for feedback.
What is one strategy that has helped you grow your business?
Advocacy for the patient is the most important thing. I intimately know the clinical workflow. I understand the regulations. I know how the regulations can be used to improve patient safety and provide needed real-time data. If others are unaware then my ability to communicate this to key stakeholders, from surgeons to clinicians, and provide a solution, is important. The patient comes first and it’s the frontline of my communications.
I take every opportunity to make sure people look at all regulations and push them to follow these directives. With medical devices, you have to look and follow the regulations for the device; from manufacturing thru disposition… which means thru use, recall, waste. 100% of the medical devices should be accounted for. I know people understand the passion and it is the safest way not only for the patient but for each provider entrusted with that patient’s care.
What is one failure you had as an entrepreneur, and how did you overcome it?
Trusting, at times. My first application was stolen, because I trusted the wrong developer to work with me. They saw the money that could be made, and took it.
I’m very values based. It’s not all about making money — it’s about improving patient safety. For example, we’re currently offering our UDInventory module for free to hospitals to help them identify and track their complete inventory. UDInventory will also prevent the use of unsafe medical devices and supplies. Class II and Class III medical devices will show their expiration dates so pre-planning can occur. Recalled items are immediately identified at the scan of the medical device manufacturers barcode. It’s simple for the hospital to use and help save time and money. Why are we giving this module away? Because it’s the right thing to do. As an entrepreneur you put your trust in a lot of people, and you can’t trust everyone to have the same moral compass you have.
What is one business idea that you’re willing to give away to our readers?
There are so many! The world is full of ideas.
What is the best $100 you recently spent? What and why?
That’s a great question. I went to Trader Joes with my $100 shopping budget and bought everything I needed, and still had $20 left over. So I’m driving away from the store and see a guy walking to his car who — someone known as the ‘piano guy’ who plays at Pike’s Place Market everyday, well until COVID-19. So I said “hey piano guy, he turned and I gave him the 20 bucks!”
As I turned the corner, I heard him holler, he was so excited about getting that $20. For me, giving him that $20 and hearing that gave me the biggest smile ever.
What is one piece of software or a web service that helps you be productive?
Well… two. Microsoft Teams, especially now that we are remote. We use it to connect our team, to connect our clients, and overall it’s helped us stay organized and connected. Jira, because are able to use this platform not only for our sprints but our client facing ticket tracking.
What is the one book that you recommend our community should read and why?
I tend to stay a lot within my industry. I like to look at the data. I highly recommend reading the Code of Federal Regulation Title 21 → Chapter I → Subchapter H Medical Devices. I also recommend reading “The Danger within Us” a book about the failures of the medical device industry. It’s eye opening.
What is your favorite quote?
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!
- I’m very team-orientated. Being surrounded by people who have your best interests at heart and have their own talents that they can bring to the table means you don’t spread yourself too thin.
- Combining passion and principle is the path forward.
- Patient and the healthcare teams safety is the core value.