Currently browsing The PedREST Story

PMD 1997-98 – Let the “Giant Sucking Sound” Begin

It’s a rainy day here in Atlanta and I’m sitting here thinking back on everything that’s happened from the day my sister The PedREST storyasked me to help her make her “little idea” a reality. Just about a year had passed since we started our journey and it was becoming painfully obvious that there was no way Suzanne and I were going to be able to bring this product to market on our own… The reality was that we were going to have to file some sort of patent application and neither of us had a clue as to where to begin. We would also need better drawings than the concept sketches Suzanne had created so off I went looking for a patent attorney and some engineers.

The patent attorney was not terribly hard to find…although little did I know that he was to be the first in a LONG LINE of patent attorneys we would eventually work our way through…(sorry…I mean work with). By the way – if I ever meet you and you hear this very faint “sucking sound” over my shoulder…that’s the sound of attorney and patent office fees sucking money out of your bank account …and I hate to tell you this, but once that sound starts it doesn’t EVER go away. On a positive note, you do get better at blocking it out…kind of like what happens when you live a few miles from a train track. But my apologies, I’m off topic…

So we needed a patent attorney (no way was I going to even try and file this on my own) and after speaking with a number of friends we were given several recommendations. I won’t bore you with the whole process we went through, but in case you ever find yourself in a similar situation, here are some of the questions we used in our evaluation:

  1. Does your firm handle medical devices?
  2. NDA’s: what’s needed and for whom (mechanical engineers? industry experts?)
  3. Volume of patents submitted last year and would any of those clients be willing to be references?
  4. Costs we can expect (“hourly rate” or by “# of claims” or by “total project”)?
  5. Overview of process : schedule and fees
  6. Patent research / searches: what needs to be done before / during filing?
  7. Path forward/options: a) Make/Sell Product; b) Make/Sell Prototype; c) License Patent
    • Probability of success for each
    • Expected costs
    • Timeline
    • Role of attorney in each of these options (if any)

I was also given some great “tips” from a friend whose brother was a trial attorney.
  • “There’s a lawyer’s address book sort of – called the Martin Hubbell Directory. All law libraries have them as well as some city libraries. It will tell where a lawyer went to school and background info. A lawyer may be unimpressive in school but ELECTED to a position (i.e. president of the national trial lawyers association) by his/her peers. If the lawyers themselves elect someone that’s impressive”
  • “Also check with their insurance company for how long they’ve been insured and how many times they’ve been sued and by whom. The court cases for lawsuits are on public record and you can read them at the court house…if they’ve made lots of stupid mistakes that got their cases thrown out of court, well then look elsewhere.”

In the end we chose an attorney from NYC that passed our due diligence with flying colors. It was from him that we learned some valuable lessons…

First – here’s what a “typical” patent process should look like.

  • Begin with patent search for “prior art” to see if a patent is even worth pursuing). The search is based first on appearance of item and then claims and takes approximately a couple of weeks
  • Choose materials you ultimately expect to use
  • Establish the company / incorporate
  • Contract with a patent draftsman You should end up with 2-3 sheets of drawings in approximately 1-2 weeks
  • The patent application is drafted and submitted: …After 10 days you should be granted “Pending” status; it will take approximately 18 months – 2 years to Issue
  • Create a business plan and begin “selling” to potential investors

Second – given the lack of regulation in the back of an ambulance, our device could likely be considered a “useful article of manufacturing” rather than a medical device…which could potentially save us years and hundreds of thousands of dollars in government approvals.

Finally – the process would cost approximately $6k for the initial filing with the assumption that 2 amendments would have to be filed at a total additional estimate of approximately $1.7k.

15 years, 2 US patents, 2 International patents (…and 2 others pending), a possible lawsuit and somewhere around $200,000 later, I have learned a valuable lesson:

When it comes to patents and lawyers – the word “approximately” has numerous definitions…the word “naïve” however is now perfectly clear.

Until next time…thanks for listening…

PMD 1996 or “…of course I can find data…I’m a consultant…”

Gather data??? No problem…that’s what I do…and I’m pretty good at it. …or at least I thought I was. But I didn’t really know the EMS market – especially for a pediatric product…and I was soon to find out no one else did either.

I started with what I thought was a pretty good list of some very basic questions:

I. General Market Insights:The PedREST story2

  1. Overview of stretcher market
    • Key players / competitors
    • Listing of stretcher models
      • Which stretchers are unique (independently manufactured)
      • Which are market leaders
    • Market share
    • Distribution channels
      • % VARS / Direct / Wholesale
      • Means of communication (Internet, catalogue, sales personnel, etc.)
  2. Overview of US emergency medical transport (e.g. ambulance) market
    • Ambulance company data:
      • company size (public, private & govt.) by region (if available)
        • # small (<20 ambulances)
        • # medium (21-50 ambulances)
        • # large 50+
        • how has this changed over past 5 years
      • average number of sites per company (small/medium/large)
      • average number of ambulances per site (small/medium/large)
    • Purchases (last 5 years) ambulances and stretchers

II. Pediatric “Emergencies” (1994+)

  1. Infant/pediatric ambulance (ground and air) transports
    • age distribution
    • geographic distribution (if significant)
  2. Volume of infant/pediatric transports as % of total transports conducted by various services
  3. Breakdown of call “codes” (as initially called/diagnosed)
    • % code 3: stable transport
    • % code 2: unstable or potentially unstable – not usually life threatening
    • % code 1: medical emergency – life threatening
    • Frequency of code escalation (eg. How often code 3 or 2 becomes code 1)
  4. % of infant/pediatric transports requiring “medication” administration en-route

Truth be told there were more questions on my list, but you get the idea. It seemed like this would be a good place to start. So armed with my questionnaire I started my research. Unfortunately at this point the internet was still in its infancy. While today you could type in “ambulance crash child transport” and get tens of thousands of references, back then the results barely registered.

My luck didn’t get any better by phone…I tried the American Ambulance Association and was referred to a nurse at the Walter Reed Hospital who referred me to an editor at JEMS magazine (an EMS trade publication) who referred me …and referred me…and so on. The list was endless…and no matter who I contacted no-one had the information I was looking for. What amazed me was the difficulty I was having even finding “the basics” – i.e. the number of ambulances in the US…and the number of crashes they had – forget trying to locate anything pediatric specific.

It wasn’t that the people I encountered weren’t helpful. The basic fact was the information was not available because it wasn’t being gathered. No-one was tracking the number of ambulance crashes taking place in the US primarily because no-one was reporting them. And why would they??? The only crashes required to be reported were the ones that resulted in a fatality. It would not in fact be until late 1999, with the creation of an internet site called EMS Network News that we would finally see how “big of a deal” the issue of ambulance crashes truly was. In the meantime, I was beyond frustrated – feeling like I had failed before I’d even begun. Still I had made a promise that I wasn’t quite willing to let go of… so I made a decision – a leap of faith so to speak, that this was (or would be) something that really mattered once people finally knew about it. I hoped for the best …and jumped. …thanks for listening…

In the beginning, the PMD story: “Dying to Save the Lives of Kids”

I think it’s time…

PMD or Pediatric Medical Devices has been 15 years in the making. …or rather 15 years of my life. I kept thinking well when everything is done…when the PedREST finally comes out to the market…when we actually save a child’s life…then I’ll tell my story. But that hasn’t happened…at least not yet… and there’s no guarantee of when it will… so I think it’s time to tell this story to the best of my ability and hope someone gets to hear it…

The PedREST storyI probably should tell anyone who decides to stop by and read this that this is not “light reading” for a slow weekend. As I said at the start, it’s been 15 years. What I didn’t say was that during those 15 years, I’ve had someone close to me try and take controlling interest of the company, licensing negotiations fall through at the eleventh hour and trusted industry professionals “borrow” our ideas.

Truth be told it hasn’t been all bad. Because of this journey I’ve met some wonderful, truly selfless people without whom I would have lost faith a long time ago. And I founded this community – something I am very proud of…

But I’m getting ahead of myself. To really tell this right I need to go back to when it all began – September of 1995 when an EMT – my little sister – invented something she believed would save the lives of kids. I’m not going to retell her story since it’s already been told here. What I will say is that it started with a simple concept drawing on construction paper. Then in July of 1996 she came and asked me for my help…could I make her dream a reality? Of course I could…or so I thought.

People will always tell you things like …never give up… believe in your dreams and they’ll become a reality, …even “build it and they will come”. You know the sayings…and I listened to all of them. Bringing a new product to market is never easy…it’s also not inexpensive (as I soon discovered). It doesn’t care that the US has gone to war, or that we’re in a recession, or even that the job that pays the bills has come to a standstill. You just have to keep going and make tradeoffs…what will you give up this month so you can pay the attorneys, the engineers, the prototype guy? But you can only give so much before it crushes you and at one point it almost crushed me.

I am stronger now and rebuilding my life. And I think that’s why it feels like the right time to share this. … maybe someone can benefit from my mistakes …maybe someone who’s going through something like I did can take courage in knowing it is possible to come out the other side. For whatever it’s worth…my story begins here… until next week…thanks for listening…

Because she inspired me

My little sister Suzanne and I were always very different…right from childhood. She looked like my mother, blonde and very pale – she always hid from the sun. I was brunette and tanned easily, just like my dad. Her hair was kinky curly (she hated it), while mine was straight. She lived in a world of her own creation and got into trouble at school and at home. I was the “good child” with straight A’s who rarely was cause for concern. And boy we hated each other…

According to Suzanne, life came easy to me…anything I wanted I would always get, while she would struggle so hard, “felt stupid” and would always come up short. Her greatest joy was wreaking havoc on my “perfect little world”. So I separated myself as far away from her as I could – physically, emotionally – so many of the choices I made were to distance myself and “not be like her” in any way I could.

Suzanne had a very difficult time growing up – and though I was part of it – I know there was quite a bit I did not really see until years later. She struggled with drugs and attempted suicide when she was still a teenager, and depression for a number of years after that, apparently always hating herself more than she hated me.

And just when we all thought she didn’t have anything left to give – Suzanne found a new path to follow. To our amazement she chose EMS – to save a life instead of taking her own- she wanted to make a difference. And not only did this “little girl” work as one of the EMS crews that helped secure the scene after the bombing at the Atlanta Olympics, but this same girl who thought she was “stupid” invented the device I blogged about earlier that will one day make it safe for all little kids to ride on ambulances. (…I read this and remember why we teach children that “stupid” is a bad word)

Several years ago Suzanne had to quit EMS. Every day since then, like many of us she struggles with questions of am I good enough…smart enough…am I deserving…can I still make a difference… and every day no matter what anyone tells her, I don’t know if she believes it.

I grew up not wanting to be like her…but I would be half the person I am today without her. So much of what I am, what I have and what I do that I am proud of is because of her. And I hope someday she reads this, because I want her to know, if I make a difference with my life…that will be because of her too.

An EMT’s Story

Below is a story told to me by a young EMT back in 1995 – what is truly amazing is how little has changed:
“On Tuesday, September 19, 1995 at approx. 4:00pm, while working on an ambulance, my partner and I were called to do a routine transport at Hugh Spalding Children’s Hospital, an affiliate of Grady Memorial Hospital in Atlanta, Georgia. We were dispatched to pick up a mother and her infant and bring them back to their residence. I informed my dispatcher that we were not equipped with an infant seat on the truck. I was told to follow usual procedures (strap the mother to the stretcher and have her hold the baby on her lap) and to transport them . I felt this was wrong, but did as I was advised. When I returned to the station I sat down with my supervisor and told him that what I had just done went against everything I believed in. My supervisor respected how I felt and said that what he could try to do was get an infant and toddler seat and keep it in his car and first respond to the scene with us from now on. While I appreciated his efforts, I still felt that this was not enough.
I thought about when I had worked at Egleston’s Children’s Hospital in Atlanta. We used infant and child seats for transport but they were always so difficult to attach to the stretcher. The seat is shaped to fit a car’s seat belts. To attach it to a stretcher meant adjusting the stretcher to an upright position and strapping it in. In doing so, the bottom of the child seat was suspended mid-air and needed to be held in place by sheets and blankets propped up underneath it. No matter how we attempted to manipulate it, it was still unsteady.
And attaching the child to the stretcher was simply not an option. The reality is they are just too small: the straps cover half of their body and can’t restrain them. The straps can’t be tied tight enough to keep them in place or it will hurt them, and when the straps are loose, the child slides all over the stretcher. This makes for a miserable trip for all involved: crying child, stressed parent and helpless crew.
Which brings to mind the dangers of the everyday baby seat being strapped to a stretcher. While working on the ambulance at Egleston’s Children’s Hospital, 9 out of 10 children transported were going from one hospital’s emergency room to the PICU (Pediatric Intensive Care Unit) at another because they were in severe danger (they were having seizures, their airways were compromised, they had head injuries or were intubated). If any of those children went into arrest along the way, there were approximately 6 time consuming steps that had to be taken before CPR could even begin:
  1. The safety seat shoulder straps had to be removed from the infant/child
  2. The infant/child had to be removed from the seat. (Remember that at this point in time, someone is standing up in a fast moving ambulance, holding a non-breathing infant in their arms, trying to support themselves and the child without falling over)
  3. All of the sheets and blankets that were previously holding the seat in place on the stretcher have to be removed. (These get tossed on the floor and everyone involved keeps kicking them out of the way so that they can help during the trauma…in effect more time wasted).
  4. The straps holding the child seat in place have to be found (under the bar of the seat) and released, and the seat has to be removed from the stretcher.
  5. A short back-board must be placed on the stretcher so that heart compressions may begin
  6. The baby is positioned on the board, and resuscitation can begin.

But that is not the end to this emergency. The infant/child is still sliding all over the place. The technician’s hands can easily be misplaced while doing compressions and there are many other dangers that can occur to this un-restrained child while racing to the hospital.

My partner and I conducted a run-through of this procedure using a doll as a prop Going as fast as we could, it took us 2 minutes and 4 seconds. According to the “Brady Emergency Care” book, “all cells in the body need oxygen for survival. Lethal changes will begin to take place in the brain within 4-6 minutes without a constant and adequate supply of oxygen. Brain cells begin to die within 10 minutes.” It’s clear that two minutes without air for an infant or child is way too long!”

The EMT went home and drew what she believed was needed to solve this problem. It is my hope that somehow, someday, I will help her do that.