Fresh Start

Friends, good morning from sunny, blue-sky New York City, from your good friend Sarah.  The New Year brings a fresh start to everything, and you can practically feel the excitement.  Today has brought me a happy new project, and I am already gearing up and preparing to lead another team.  I could not be happier.

 

When I work on my medical research projects, we plan for the first patient to get the first device, ever, in the world, with years of planning and preparation.  The engineers draw and build and tweak and test devices for heart treatments in the lab, on the bench, then in animal models.  The clinical teams work for about 6-12 months (sometimes faster, like our project in Australia last year where we worked around the clock for 4 months straight).  We put our hearts and souls and backs into it—making sure all of the legal paperwork, the patient risk disclosures and consent forms, the training manuals for surgeons and nurses, the protocol design of how to screen for, then implant, then follow how the product works in patients around the world, and the how to gather up all that data and safety information into one major report that describes how all of that hard work turned out. 

 

If you get it right, different countries’ governments give you permission to market and sell your product.  Every individual day of market approval delay can cost the company a lost $1.2million in profits.  For this reason, time is important, along with quality and value.  Moving first to get your product on the market gives you an advantage, because yours is the cool new product that also helps set the pace for reimbursement, and after all that work, people need to get paid.  Insurance companies and Medicare need to know what the costs are and what the outcomes of using the products are so that they can figure out how much to pay hospitals as the reimbursement for the charges of using those products.  The VA and big hospitals figure out which products to use based on early on cost but also down the road costs, as they look very, very carefully at the safety data and whether or not people have to stay in the hospital longer, have more drugs or treatments, and whether or not they need additional hospital stays.  It is a big deal, with each medical device taking about 3-5 years to get on the market and costing sometimes a hundred million dollars to get it right. 

 

One cool new product can change treatment paths for a disease forever.  If you can figure out how to fold up a teeny tiny little device that needs to go up into the heart to burn away extra cells that make the heart beat too fast and then thread that up through a small blood vessel, you don’t have to open up a chest cavity to do that procedure.  That means less time for patients to heal, less chance of infection, and hopefully lower costs.  This is the change we saw over the last 20 some years of research.  The way my grandfather’s heart condition would have been treated years ago is now archaic. It is exciting to work in a field where I constantly get front row seats to see what is new, coming down the pipeline.  Each medical conference is a showcase of different company’s products and research progress, and the “homecoming” we have as all of us researchers and doctors from around the world see each other again is a wonderful part of my job.  We become family, we become so close as we plan and work and watch and wait and finally treat the first patient in the world with a new device.  There are hugs all around as we show each other pictures on our phones of kids, vacations, meals in restaurants, and surgical case summaries.

 

Each and every time I walk into an operating room, no matter what faith the patient or doctors are (or not), I always prepare myself for that day by taking a little private moment away from everyone, saying a little prayer for those patients’ safety, for good work by the doctors and nurses.  It is part of my mantra, my routine to prepare myself as I, too, am part of these patients' care as I work to protect their rights, safety and welfare.  I think about this focus of energy and intent as these volunteer patients who are very sick put themselves into our hands in the hopes of being treated well and having their normal lives back.  I think about each patient’s family---their spouses and children, their Friends and coworkers, and how this person, there, on the operating table, is a Someone, is loved, is important.  And then, when it is time to start the procedure, I turn all that off and become Scientist Sarah, with emotion shut off and only science focus as I observe and dialog with the doctors, talking about the procedure, the different patients’ anatomies, the way the device is working in each person, what might improve it, reviewing our training manuals and study protocols and learning, learning, learning, from each and every case.

 

When we start our cases, I do not touch the patients, because I am not a doctor, but I and my teams often attend the cases, to provide support and to remind the teams what the manuals say to do in case something goes wrong. Usually things do not go wrong, but we are there, all together, in case something does.  Here I am with one of my teams, after we used a product for the first time in the world, which went beautifully.  What an exciting day that was!  There were lots of hugs and pictures that day, and there were lots of congratulations in multiple languages as I and my team spoke in English, French, Spanish and Dutch, since we were a global team that day.

 

On the good days, we take lots of pictures of the operating suite team and have 2 emails ready to send:  one that congratulates the team and lists out all the team members from all the different departments and hospital teams, and one that is the email that allows the pre-written press release (once it has been reviewed by multiple teams of lawyers and marketers and clinical researchers for accuracy) to be sent to the press.  On the good days, we celebrate while in our medical scrubs, hugging each other or bumping fists, or, if it is a long day, after multiple difficult cases, with just a weary, thankful look as we sit in the doctors’ lounge and talk about how things went.  Sometimes it does not go so well.  Sometimes patients, who are very sick, die.  When that happens, until the paperwork is complete, we have to shut off the emotion and be scientists and carefully document what happened, so that we can study it again, with our teams of engineers and doctors, safety managers and statisticians, data managers and field clinical engineers.  There are days that are very difficult, as I have to do my job with the doctors before they go speak with the families.  It is not always easy to do what my teams and I do, but we know how important it is.  There is nowhere else I would be.

 

I love my job.  I love the excitement of leading a team as their project manager, director, vice president or auditor, helping the newer team members learn the hows and whys we do things the way we do in all my different clients and different areas of medicine.  I love teaching operating room etiquette and how we talk to doctors, both in praise and respect but also how to talk to them as peers and collaborators, when things do not go well.  I love the listmaking and task completion.  I love knowing we got it right.  I love meeting people on airplanes who ask what I do, and when they tell me what kind of medical device or drug they were given, that they tell me how good they feel now.  I love the teams who work so hard and make jokes even under pressure, as we go over and over and over the laws of each country, discussing the details of how to make sure each and every document is exactly compliant and correct.  I love the budgeting, the negotiations with the FDA and Australia’s TGA and European countries’ Competent Authorities and Health Canada and MHLW in Japan, and how we work together to make sure those patients are as safe as possible  I love what I do, so very much, every day.

 

When I think about this work and my teams, I feel like my life has exactly the purpose is was meant to have.  It is stressful, so very stressful some days, but I love each and every moment.  When the case is over, and when we have some down time, there are celebrations at the different restaurants where I also cook, and being able to blend both of my worlds together makes me feel like I am a parent, with all my kids coming home and sitting around the table, happy and content, celebrating what we made together. It feels good, this work, this purpose, this teamwork, and my part of bringing them all together so that they can shine, shine, shine, is what makes me the happiest of all, because what I love best is figuring out how to identify and bring out the best in everyone. I do not need or want to be the star, but I sure do love being part of the team and helping them get there.  Any time I get an email of praise from a manager or president, you will see me respond in thanks but also mention by name all of the other people who were right there with me, so that we could accomplish the good patient work, together.  Nothing is just about me....it is always, always, always a team effort.

 

As I work with my teams in medical and in building up a few restaurants, today on this sunny, blue-sky New York day, I am happy for this new year and this chance to do it all again.  I have been asked to lead another team with one of my favorite clients, from the ground up, and I am so excited to partner with them again and be part of the team that brings cutting edge treatments to thousands of patients, literally, around our little world, together.  I only hope the new restaurant build-out will be complete by the time we are ready to celebrate!

 

Wishing you a good day filled with adventures and new things and a purpose doing exactly what you are meant to.  We are so lucky in how we are so connected.  Every little step you take, every little job you do, can make the difference someone needs in their life, so never, ever forget that you are part of something wonderful.

 

Have a good day, today, Friends, as I send you lots of love from New York, soon to be Minneapolis, to start a fresh new project, once again,

 

Your Good Friend Sarah