Two months later

“Ray, look at this.”  Morgan held up a pale yellow gadget, about the size of a quarter.

“What is that?”

“This,” Morgan paused for emphasis, “is a valve.  I haven’t slept since we brought Isaac home.” Morgan continued more quickly and energetically, “My mind’s been racing, knowing there has to be a better solution, and after researching everything I could find on his condition, expecting there had to be an alternative, one night I woke with a start—and could see with perfect clarity exactly what he needed. In full color, three dimensions, I saw the very thing that would solve the problem, and I’ve spent the last four weeks ‘round the clock developing it.  This is it.”

The doctor took the device and examined it from all sides.  His mouth hung open slightly, as he considered the challenges that artificial valves had always been known to have, and with every turn of the object and every twist and bend of the fingers that held it, the realization washed over him that this inspired design avoided both the coagulation problems of the more durable mechanical devices, as well as the durability problems of their bioprosthetic counterparts.

The features were so advanced it seemed like science fiction. Dr Golward turned the valve over in his hands many times as he continued to examine the prosthetic device.  He muttered thoughtfully, “This porous element might actually promote a strong matrix bond between the heart tissue and valve, maximizing implant stability…”

Morgan interrupted his thoughts.  “The valves are made of a synthetic polymer that possesses the physical qualities of natural valves: elasticity for preventing deformation and adhesions, efficient opening and closing of valves, and compatibility with the natural healing process. So, no deformity, flow, clot or infection problems, essentially eliminating the need for multiple surgeries, heart failure, blood thinners…”

“Unbelievable, Morgan.” Dr. Golward examined it pensively one more time, then began to question, “But—”

Reading his thoughts, Morgan interrupted.  “Ray, get this.” Morgan brought out a notepad with his midnight scribbles on it. Enthusiastically he pulled his chair closer to Dr. Golward and spun the pad around on the desk to face them both.  “Look at this—with thousands of medical devices and a lab full of building blocks for everything my company makes, when I saw the vision for this, every solitary thing that needed to go into it was apparent as well.” Morgan chuckled, “I jotted it all down, wondering if it would still make sense in the morning.”

Dr. Golward pored over the notepad and eventually whispered, “This is a dream.” Looking up at Morgan, eyes wide, he continued, “Can this be for real?”

Morgan rattled on, “Thrombosis: not a problem. We take the DXio45 melding component, combine it with ROJ-62, overlay it onto the methyl methacrylate fiberflex and you have an ideal replication of the endothelium of the connecting heart chambers.”

Dr. Golward remained in a daze, and Morgan kept going. “With the new technology for fusion in cranioplasty, it seems the same process could bond this compound to the outer surface of the prosthesis, and voila! You’ve got built-in endocardium—the body won’t even know the valve is there.”  After a moment he burst out a chuckle and excitedly pointed to one part of his diagram, “Do you see how this combination could even lay the foundation for potential self-repair?”

Dr. Golward sat back and closed his eyes, looking for a hole in Morgan’s theory.  Finding none, he began with a sigh, “If this is truly what it seems to be, it’s revolutionary.  The world will know about this, Morgan!  It needs testing and mass development!”  Leaning in he continued, “You’ve got to submit this to the medical journals—it’ll save thousands of lives every year!  You always said you’d be saving lives in the trenches!”

Shaking his head, yet smiling, Morgan threw his head back and countered, “Oh sure, who would listen to me?  I’m no medical doctor; I’m just a parent who is obsessed with seeing my son, the only child I have, grow up. No, Ray, the world isn’t ready for this.  It’s for Isaac, and we don’t have time to wait for the medical community to accept it.”

Dr. Golward cautiously tempered his excitement.  With his thoughts racing faster than he could speak, he blurted, “What are you saying?  Wait—no. This can’t be for real. It’s—you—what about…” With his thoughts in a blur, he eventually reverted to a question that was at least possible to formulate. “Morgan, how in the world did you think of it?”

Morgan replied, “I couldn’t have designed it on my own if I tried, Ray.  I’m not that smart. It’s bigger than me, and so I’ve got to go with it, follow where it’s leading.”

Thoughtfully Dr. Golward tried to process this incomprehensible event.  He was witnessing the birth of a groundbreaking innovation, and had trouble digesting the significance of the moment.  Slowly muttering out loud, he finally concluded, “You’re right, you’re not smart enough to come up with this on your own; somehow this passion of yours has become your portal to genius!”

“That’s about all I’ve got, Ray.  I feel the passion in my veins.  It keeps me awake at night. There’s nothing more I want than to know Isaac will give me grandchildren to carry on the family name. I want people—family—a hundred years from now to know and care that I lived.”  By now, Morgan’s eyes were misty.  One tear eventually fell, and looking embarrassed, he quickly wiped his face dry.  “I need my son live a full life, without the constant threat of another operation, and I believe this will do it.”  Morgan took a deep breath, and mustered the courage to say, “That’s why I need you to perform the surgery.”

Dr. Golward’s face fell.  “You want me to do what?”

“I need you to give him this device.  Put it in there.  I can’t do it myself, or you know I would.”

“It’s too experimental—too infantile!  Where’s the lab testing?  Years of experimentation?  This is your son, for crying out loud, not a laboratory rat!  Have you gone mad?”

“You said it yourself, doc: this is genius; I didn’t come up with it on my own.  I’ve been given a solution to save my son.  Who am I to reject it?”

“How will you pay for this?  The hospital, equipment, medications, the physicians?  No insurance company would ever touch this.”

“I’ve already cashed in my entire portfolio.  Much of the equipment can come from my own company, and—since on paper it can be considered product development and testing—I can utilize company funds, to an extent. I’m prepared to cover the facility, medications, and most of what your team would require, but I’m hoping you’ll do your part—as a favor.” Morgan searched the doctor’s face, which held back any sign of cooperation. “Let me try to simplify the idea. This proposition is not really that difficult, Ray.  The procedure is routine, just with a different device—same contact points, same procedure.  Only this time, no complications.”

“Do you have any idea how much red tape there is to go through?  This sort of thing takes paperwork, releases, and legalities. I’m not sure Isaac has that kind of time, Morgan.”

“You can push it through, can’t you?  I’m on my knees, Ray. I don’t know what else to do. He won’t always be a candidate.  I’m afraid we’ll lose Isaac if we don’t do this.”

“You could lose Isaac if we do, Morgan.”

“Just tell me this.  Is it possible?  Can you use a device that has only been tested in the research and development lab at the plant?  Can you get a team to do it?”

“It’s complicated. I can get the facility and a team, but this is a Class III device, so without approval from the Food and Drug Administration, we need an investigational device exemption—an IDE—and even with that we can’t do anything for at least 30 days, probably more.”

“But if you recommend it, and I consent—I’ll sign anything you need me to sign—then what does it matter to the FDA?”

Even though Dr. Golward could see the feasibility and genius of the invention, there was a part of him that had a hard time not seeing the gadget as home made, and the thought of being responsible for its performance to any degree terrified him.  There was comfort to be had if they would just slow down long enough to allow the federal agency to either lend support or shut it down entirely according to their judgment.  Apparently, Morgan didn’t care what the FDA thought, and Dr. Golward desperately wished that he did.

The doctor was certain that questioning the suitability of the gadget further would fall on deaf ears, so he tried another argument: “Well, here’s the thing, Morgan.  What if it works?  What if you’ve created something that would help others?  Naturally I’d want this for your son, but you can’t expect me to approach this with the same indifference as if I were helping you fix your car. For another thing, if you’re asking me to do a favor like this, ethically, I’d need to take this on with the ultimate intention of letting it help humanity on the whole, not just Isaac.  That requires an IDE to treat him as part of an approved clinical study.”

“So under those terms, how long before he’d get the surgery?”

“Honestly, I’m not sure he ever would.  Before approving the study, they have to review all the documentation from prior studies—laboratory, animal, other human tests—a proposal for how we’ll run the study, consent documents. We have none of that. If by some miracle they approve the request anyway, then there’s a good chance they’ll impose some serious restrictions.”

“There’s got to be another way, Ray.”  Morgan paused awkwardly and then continued, “You know what? Let’s not talk about this now. You’d probably like some time to digest it. Come to our house tonight.  You’ve always relied on Rita to keep my head on straight. The three of us can talk about it at home.”

Dr. Golward was somewhat surprised by the suggestion because he knew Rita was too level headed for this, and he thought it odd for Morgan to suddenly shift from dogged assertion to being openly willing to bring her into the conversation.  It actually sounded like a safe and perfect way to bring this madness to a peaceful conclusion. “Great. I’ll get back to work and then,” shaking Morgan’s hand he promised, “I’ll swing by on my way home from the clinic.”

~~~~~~

Follow Morgan who needs an unauthorized surgery for his son, Richard and Felicity who are at the end of their financial rope, and Ray who needs to find $4.5 million dollars in just a few days, as they each discover their portals to genius.

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