A Prodigious Future for Prodigy Diabetes Care

| Apr 2, 2011

Prodigy Diabetes Care is an aptly named company, a very young enterprise with the talents of a much older organization and a future that promises prodigious rewards. It was founded in 2006 by Ramzi Abulhaj and Rick Admani, two brothers from Palestine who are its sole owners. In the five years since then, they have built a company that is successfully competing against the diabetes old guard by focusing on engineering and a unique marketing strategy.

Rick and Ramzi got into the diabetes business by making lancets and meter test strips for large manufacturers that branded the products as their own. Ramzi recalls, "Then we lost a bunch of contracts for the companies that we did the strips for." Rick says, "After we lost the contracts, we figured, we have all this equipment, all the know-how. But we also knew that in this business, it would require a lot of sales and marketing, a lot of advertising, so we wanted to come up with a gimmick that could give us an advantage over the competition.  We had a grandpa who was diabetic and lost his vision, and we figured, ‘Why not introduce an audible blood glucose meter?' So we started working with the American Federation of the Blind and the National Federation of the Blind."

"We brought them the first meter, and they said, ‘Great, it's good, but it's not going to work. We want you guys to fix these issues.' So we said, "That's fine,' and a month later we came back with a new product. They said, ‘We can't believe you guys work so fast. We've been working with big companies for years trying to tell them to do these changes, and nobody would listen to us.' We went back and forth, back and forth, and finally we came up with an ideal product, which was the Prodigy AutoCode."

Rick goes on, "And then we came up with the Prodigy Voice, because the NFB said, ‘The AutoCode is a great product for people with low vision, but we want blind people to have total independence, and they need to be able to set up the meter, the time, the parameters.' So the Voice has additional features to give complete independence to somebody who is totally blind at the time of getting the product. We have a call center 24/7, and one of the specifications that the NFB required was to have them come in and train our staff how to deal with blind and low vision patients. We have certification from the NFB on that."

Ramzi says, "Twenty-two percent of diabetics have problems with their eyesight. That's a very large percentage, and the truth is, with technology advancement, everybody's making meters smaller and smaller and smaller. If everybody's eyes are getting worse and worse and worse as they get older, by default we have a very captive audience."

Rick adds, "To be honest with you, I would say maybe about 20 percent of our customers are blind or low vision. But the majority of the people like to have an audible product. They think it's cool because it's newer technology, like having navigation in your car that can talk to you versus mute navigation. We also have two non-audible meters, one for the younger population that looks like an iPhone. It looks cool, with different colors, and is more meant for the juvenile diabetes patients."

Ramzi himself has had type 2 diabetes for about 13 years. He recalls, "I was selling meters, and a customer said ‘Let's test you,' and I was around 450 mg/dL. My grandfather actually lost his eyesight through diabetes, and both my parents had diabetes. That's why Rick still works out every day at the gym, just to make sure he doesn't get it. Probably he will get it sooner or later." To check his own blood sugar, Ramzi says, "I use the AutoCode, but I do have to admit that I shut it up. I put it on mute." His A1C is only 5.6%.

Rick and Ramzi are very enthusiastic about the products that they have in development, including an audible insulin pump. Ramzi says, "Our pump is both tethered and nontethered, and it gives the smallest dose ever of any pump out there. Also, we put in a black box that can report back, to the doctor or the FDA or whomever, exactly what happened with that patient and that pump on a second-by-second basis, which none of the pumps out there has."

"Last year, the FDA wrote a report that was very damning to pumps and pump companies. Now, to approve your pump through the FDA, the requirements are much more stringent, which is fine, because we don't want to get into a market with a bad product. We want to make sure that the product is safe. We feel that with the technology that we're incorporating, we're going to be probably one of the safest and most accurate pumps out there."

"I'll tell you a quick story," says Ramzi. "When we started many years ago, a guy said to me, ‘Well, you know, the FDA says it's okay.' I said, ‘Well, great, but the FDA is not buying.'  The FDA is a guidance. That's all it is to us. It's not going to take your product out and sell it. You still have to look at your core business, which is going to come from your customers. So you can always exceed what the FDA wants, and that's the way we look at things. Okay, the FDA tells you the bare minimum requirements, but if you make a product that is much better than that, then you're going to be able to sell it much easier."

In addition to their meters and pump, Prodigy makes the Count-a-Dose product for people with poor vision, with which they can measure out their insulin. Rick says, "It was originally with a company that pulled out of the market because of FDA issues. An advocacy group called us and said, ‘This is a product that a lot of blind diabetics depend on, and we want you guys to figure out where the issues are and bring it back to the market.' So we acquired the line, dealt with the FDA, and we brought the product back on the market."

Ramzi says, "Another very interesting product that we have is the patch. There's nothing like it out there in the market. It's basically an insulin pen onboard. It has a port, so you don't need to inject yourself 150 times a month. Instead, you're going down from 150 times down to 10. It uses insulin from a vial, which is much less expensive than insulin in an insulin pen. You load the insulin into the device, which is a little bit larger than a quarter and holds 200 units of insulin, and it sits on your body for three days. When you want to inject insulin, you slide the slider. It's spring loaded, and every time you activate it, it releases one unit of insulin."

"If you have to inject long-acting insulin, we also incorporated another port so you can inject it into that port, so you're not injecting your body again. It's kind of like the iPort, but the iPort did not have any insulin. This is an iPort with insulin onboard. It's a mechanical pump."

Ramzi continues, "If you look at the total type 1 diabetics in the United States, about 80 percent are using syringes and needles. Only 20 percent are using pumps. You have to be a little bit tech-savvy in order to use the pump. And a bunch of the people who are maybe a little older don't feel that comfortable with pumps, especially if their diabetes is under control. But they also don't want to be injecting themselves 150 times a month, which is where our patch comes in. And in addition to that, it can be used by type 2 diabetics, which is a much, much larger market." Rick adds, "It's under FDA review. We're expecting the third quarter of this year to hit the market. We call it the IQ Patch."

Ramzi goes on, "Another market that we are now going after is the nursing home market. It's probably about 100 million dollar a year market in the United States. We did not want to go in with a home blood glucose meter into this market, so we're coming up with a hospital type device with bar codes, a bar code reader, so that it is patient-specific."

"Let's say there's an average of somewhere about 25 diabetics per nursing home.  The nurse has to go out and test the blood sugar of all 25 people, and then she has to record each reading on a piece of paper. And then she has to go back to the nurse's station and pull out each person's file and transfer the data from that paper into each file. And this has to be done, by law, three to five times a day for all 25 files."

"With this new device, the nurse scans her own identity when she turns it on, so now the device knows which nurse is doing the testing. Then she scans each patient, and now the results are in the device, patient specific. And these meters not only do blood glucose, but they also do blood pressure, temperature, and oxygen saturation. So when the nurse goes back to her station, she can just put the device in the cradle and all that data is in the computer, specific to each patient. And then she can hit print, and it will print everything. So now all she has to do is pick up the papers, which have the patients' names on them and all of their vital signs, and then stick those papers into the files. It's really a lot of time and money and effort that you basically take away, making it much simpler for a nursing home. The truth is, the hospitals are quite automated, but if you go into nursing homes, there's hardly any automation. This device brings them into the 21st century."

"We're looking to give these meters out for free to the nursing homes," Ramzi says, "and we will probably be in the market with them before the end of this year." The company intends to make their profit on the strips, which, as Ramzi notes, "is not a novel idea." He says, "We still retain ownership of the device, and as such, we will keep the warranty going forever. We took this same idea, believe it or not, and we applied it to pumps, because usually you only get a warranty on a pump for a year. Our pumps can have a lifetime warranty."

Ramzi says, "We also have the Prodigy IQ laser, a laser lancet. Basically it's painless. There is no other laser lancet on the market. Other people have tried to do it, but they came up with devices that were 13 to 15 hundred bucks. We're making this thing for about 100 bucks, and we're going to take it to the hospitals. And then you don't need sharps containers, you don't have cross contamination issues, you don't have any of that stuff with this device. It has a plastic cover, but you can throw the cover directly into the garbage. You don't need to have a biohazard container."

"The misconception is that a laser causes blood coagulation, but to coagulate the blood, you need somewhere between eight and 12 seconds. The lancet is very fast. What you're doing is you're going in and you're boiling the pores under the skin. You blow them up, and that's how you make the hole. It doesn't sound too good, but actually it is much simpler and much cleaner than piercing the skin with a needle or cutting through it with a blade, and the healing process is much faster as well." Rick adds, "We think that we will be done by the end of the year. It's with the FDA right now."

"As a company," says Ramzi, "we really try to go after very interesting markets with very nice niches, go after products using new technologies out there, and we believe we'll be very, very successful at it." Rick adds, "We are a unique company. We make decisions very fast, we're extremely aggressive, and that's what has made us very successful. Maybe stubborn is part of it as well. I see us continuing to grow with this diabetes market. We are coming up with a pump, infusion sets, the full product line, and we see ourselves offering a full solution to a diabetic patient."

Ramzi says, "We're a very young company, and we are basically an engineering company first. We spend a lot more time on R and D, and we have a very large engineering department, about 18 engineers, but we have a very small marketing department and a very small sales department."

"We have a business model that is a little bit different than other big companies," says Rick. "We go after the payers, which is the managed care, insurance companies, and the buyers, and we offer them value, a high quality product. The business model of other big companies is, they basically have hundreds of pharmaceutical reps visiting the doctors, giving them free samples and doing dining and wining, and this is how they try to get the business. We don't have that additional cost that everybody's doing. We go for large quantities to the managed care. If you look at our raw materials that we are using to make our product, they're identical to the other big manufacturers. How do we make it less expensive? We don't have 500 people marketing the product."

Rick says, "We are bringing a lot of value product into the market right now, and obviously, because of the economy, we're becoming a lot more attractive to the market. We were awarded a sole source contract with the state of North Carolina. Our products are the only approved products to be used by Medicaid recipients within the state of North Carolina. Right now we are working with other states as well, to do the same."

"It was actually a huge controversy because it was a no-bid contract, and a lot of the big companies did not like the way it was done. But we saved the state 60 percent of what they were paying, and the whole bidding process would have taken another year and a half. We saved the state in excess of 15 million dollars a year."

Ramzi says, "Right now we have several things in the oven, so to speak. We have the pump, we have the patch, we have the laser lancet, and we have the hospital machine. We've been very lucky. A lot of companies, due to the economy, are not doing so well and have really suffered. We're actually growing every year."  


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Posted by Anonymous on 5 April 2011

Great story!

May God bless these guys and their business!


Posted by Anonymous on 5 April 2011

I can't wait to see these products. Is there a website?

Posted by Anonymous on 6 April 2011

The Prodigy meter is now the only meter that can be used by our Medicaid recipients in North Carolina. It has proven a very unreliable and inaccurate meter. It gives such far off results that most CDE's in our state request Medicaid for another meter for their children with Type 1 diabetes so they will be safe. These men also have been sued in the past for patent violations with other medical equipment. I am disappointed that no one did homework on these men. The Raleigh, NC News and Observer has done many front page stories on the questions surrounding these men and the meter quality.

Posted by Anonymous on 6 April 2011

I have the misfortune of living in NC and have to deal with patients that have to have the Prodigy meter - it's awful. Patients hate it, the results are often inaccurate (two BG in 1 minute off by as much as 200 points). I'm actively working to see that NC Medicaid drops Prodigy and goes with a better company.

Posted by Diabetes Health Staff on 19 April 2011

We asked Prodigy to respond to some of the feedback to this article and have provided their response below: We have not received any substantial criticism about the accuracy of our meters, strips, or service from the State of North Carolina Medicaid administrators or the Department of Health & Human Services. When a patient or caregiver complaint regarding our product is received by state officials, Prodigy investigates each case and reports its findings to the State. We have uncovered several inaccurate reports by patients or providers, and when we have discussed issues with the patients, we have been able to determine why they were getting inaccurate readings, and in each case it was user error. Our experience with complaints from people other than patients is that they were generated by competitors. On November 4, UNC-CH conducted a test of the reliability of Prodigy meters and strips. The technicians tested 100 Prodigy strips (from 3 different production lots) with 10 Prodigy meters against three different levels of known blood-glucose samples. All 100 tests resulted in readings that were within the FDA standard, and on average were much better than the standard. The test results are available for review. We are in the final stages of contracting for a full comparative study of Prodigy meters/strips with all of the major manufacturers, and are confident that that the results will support Prodigy's™ claims of accuracy and reliability. Unfortunately, no one escapes their detractors in these days, and we are no exception. However, our experience has been far more positive than negative with the vast majority of providers, educators, and patients.

Posted by Anonymous on 10 May 2011

i saw their patch at the AADE show in san antonio and was impressed- until i saw that the long lasting insulin mixes in the same needle as the short acting insulin. i don't think the FDA would approve that condition.

Posted by Anonymous on 21 May 2011

These guys still doing many things around they did many faults outside US i think the government must look deeper they are bringing their meters from Taiwan and claim they are patent owners !!! in addition they are using their US nationality to do many scam outside US

Posted by Anonymous on 18 October 2011

The response from Prodigy is hilarious. Do they expect the state of NC to be their complaint department? Why should it have to get elevated to the level of the state for Prodigy to take it seriously?

I'd be curious to see how many complaints Prodigy receives about accuracy overall as opposed to how many complaints they see only from the state. Also, I wonder how many accurate reports by patients they've received instead of focusing on any inaccurate ones. They stated that they were having a full comparative study done. I'm curious to see what the results were/are with a clinical study being done on the Prodigy meters, but am sure we won't see anything anytime soon.

For crying out loud a doctor or some kind of healthcare giver has posted that numerous patients hate it and have problems with it. But, hey, Prodigy, don't worry about fixing the problems, just focus on making it look like your users are stupid.

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