Hubly Electric Drill "HED" System

Patients with hydrocephalus, traumatic brain injury, intracranial hemorrhage, cancers of the nervous system, brain tumors, epilepsy, and subdural hematomas often undergo surgical treatments which rely on intracranial access. Intracranial access today is performed both inside (180,000 procedures U.S. annual) and outside (20,000 U.S. annual) of the operating room. The current bedside procedure relies on an inaccurate, hand-crank drill deficient of any safety features. It is the only option for underserved communities or areas where an operating room is not available. This shortcoming is manifested by the 40% misplacement rate of catheters during intracranial access procedures and the 3-attempt average for functional catheter placement. 50% of bedside and 10% of operating room intracranial access procedures yield patients’ suffering from infection, hemorrhage, stroke, neurological injury, and death. Our company is solving the problem of high failure rates for intracranial access procedures both inside and outside of the operating room.

The thrice patent-pending Hubly Electric Drilling “HED” System—innovative both at the bedside and in the OR—includes a drill with (1) automatic stop, based on pressure-sensing current-monitoring, to provide brain plunge prevention but restart as needed; (2) LED pressure indicator during drilling for increased control while drilling; (3) battery power—rather than wired, electric power as in the operating room to turn burr hole placement into a one-handed procedure, increasing drilling stability; (4) unique drill bits which provide additional mechanical plunge prevention as well as visual pressure indication and increased drill stability. The HED System will be single-use at the bedside, same as the hand-crank drill used today. HED System is expected to achieve FDA clearance by the end of 2022. In our next 510(k), HED System will come in a kit which additionally includes (5) hardware catheter guidance utilizing the proven Ghajar guide technique, which has been proven to facilitate accurate freehand placement; (6) a guide hub to stabilize the drill angle during burr hole placement; and in a second generation of HED System, which is reusable with single-use bits for use in the O.R., we will include (7) a variety of drill bit sizes which can be exchanged for use in DBS, LITT, ICP, subdural hematomas, and pediatrics. 

Physician user need: ease of use to drill through bone in emergency situations, aligns with our value propositions of drill power, drilling stability, and improved feel of drill in emergent situations to ease the surgeon's manual power.

The patient's need for safety is met with Hubly eliminate risk of drilling into the brain to minimize hemorrhage and brain damage via the Hubly autotop. The patient's need for safety is also met through catheter guidance to reduce number of holes poked into brain.

Hospital finance personnel need to save money is met by Hubly both reducing patient complications (and therefore patient length of stay in the ICU, not reimbursable by insurance) and via Hubly bringing OR cases to bedside, reducing cost  for hospital and time for physician user. Additionally, the Hubly allows for more types procedures to be conducted at the hospital, which can bring in more income for the hospital or department. We are first targeting Critical Access Hospitals in the USA. 

Here's why:
1. Critical Access Hospital is a designation given to eligible rural hospitals by the Centers for Medicare & Medicaid Services (CMS)
2. The CAH designation is designed to reduce the financial vulnerability of rural hospitals and improve access to healthcare by keeping essential services in rural communities. Eligible hospitals must meet the following conditions to obtain CAH designation:

• Have 25 or fewer acute care inpatient beds
• Be located more than 35 miles from another hospital (exceptions may apply – see What are the location requirements for CAH status?)
• Maintain an annual average length of stay of 96 hours or less for acute care patients
• Provide 24/7 emergency care services

3. Cost-based reimbursement from Medicare. As of January 1, 2004, CAHs are eligible for allowable cost plus 1% reimbursement (basically the government makes sure these hospitals can't fail). My experience in these accounts is that cost really doesn't play a big role. It's what the Dr. wants...

4. Most likely this is where trauma patients will go from a large catchment area because they basically have no place else to go

Casey Grage, Co-Founder/CEO: Neuroscientist and software engineer by training, founded Hubly after familial history of neurological disease.

Tyler Panian, Co-Founder/ Technical Lead: Mechanical engineer who has brought 20+ products from idea to FDA Clearance

Dr. Nikhil Murthy, Clinical Lead: Neurosurgeon at Northwestern Hospital, previously trained at Georgetown Hospital and Mayo Clinic. MBA from Northwestern Kellogg.

Julie Byars, Quality Lead: 15 years experience creating QMS, applying for FDA Clearance & CE Mark

Tyler Holcomb, Sales Lead:  20+ years experience as a Sales Leads who led commercialization at four medical device startups from early stage through to four successful exits.

Dr. Amit Ayer, Co-Founder/Director: Neurosurgeon at Centura Health in Colorado Springs, previously worked at Northwestern and Stanford Hospitals. MBA from Northwestern Kellogg.

My (Casey Grage) background is in neuroscience and software engineering, and I’m a graduate student in applied math at Johns Hopkins. I founded Hubly Surgical because I have a long family history of Alzheimer’s and Parkinson’s diseases and I’ve seen first-hand how antiquated and dangerous this procedure is. In fact, we came together because every single one of us has a deep personal tie to this procedure, because it is the most common neurosurgical procedure in the world.

Casey Grage (CEO) and Dr. Amit Ayer (Director) met in a Northwestern Kellogg MBA class in medical device entrepreneurship. They came together over their shared interest in neurology: Casey because of her family background and Amit because he was a neurosurgeon at Northwestern Hospital. Amit identified the low satisfaction and high failure rates of today's bedside cranial access tools. Together they invented the HED System. Following the course, Amit’s protege at the hospital, Dr. Nikhil Murthy, joined the team along with Tyler Panian and Julie Byars, who had been introduced to Casey and Amit by the MBA class’ professor.

1) We know how to reach our U.S. target demographic: critical access hospitals. We need help reaching underserved communities abroad. Connections to physicians in these communities, distributors, and how best to work with local physicians. This is what we believe MIT Solve will be most helpful with.

2) I (Casey Grage) would personally like to learn how to be a better leader and manager. My team is growing beyond just a few people, and I want to know the best ways to keep new members both engaged and serious about the work ahead of us.

3) We as a company need a formalized sales strategy. Consistently, this is largest gap investors' comment on when pitching. I would love advice on commercialization activities pre-510(k) submission, post-submission, and post clearance. 

4) During the next two months, we will be conducting FDA required testing for the Hubly Drill, then in May we will be conducting our first in-patient clinical trials in Chile (finance depending), and after clearance, we will conduct post-market RCTs! We will be collecting data that I'd ultimately like to publish in medical journals for increased visibility and credibility to customers. I would like help understanding what data to publish and how to do so as well as how to organize paid post-market clinical pilots at hospitals. 

5) We have begun conversations with strategics, and I would like both introductions to other potential strategic partners/acquirers as well as mentorship on how best to communicate with them.

Hopefully, I have already explained why our solution is new and innovative compared to the hand-crank drill, which has an overall 20% failure rate and has not been changed since the 70s. 

Additionally, through incredibly minor modifications of our technology, we can easily expand into huge market indications and clinical needs like total reverse shoulder surgery and hip replacement. Presenting a $70B and immeasurable benefit to human life. 

In fact, in the O.R. today, surgeons already use the same drills for both neuro surgical and orthopedic procedures. The two best and biggest players are Medtronic Midas and Stryker Pi-Drive which are powered drills that lack autostop and hardware guidance! There is one option for autostop, called the Medtronic perforator, which doesn’t work about 1.5 times out of 200, which means surgeons don’t trust it at all. And it can only be used with a single drill bit size for a single neurosurgical procedure. Hubly is unique in the O.R. for offering autostop and hardware guidance for a variety of procedures. We and our customers believe these features should be used in conjunction with the software navigation available in the O.R.  

One year impact goals:

1. Get clinical data showing that Hubly reduces complication rate for average procedure in which Hubly drill is used by at least 5%. 

2. Enter five U.S. Critical Access Hospitals

3. Via longitudinal study, show that Hubly reduces costs to hospitals for average procedure in which Hubly drill is used by at least $2,000

4. Enter one Chilean hospital

In just the United States, 205,000 skull punctures and 4 million orthopedic procedures in which our Drilling System can be applied are performed each year. These skull puncture indications are ever expanding with medical innovation and growing at a rate of 5% each year. As we expand our product pipeline, we expect the number of orthopedic indications and specialties Hubly can address to also expand, increasing the number and quality of lives we can save through the Hubly Drilling System. In a post COVID world, Hubly frees up ICU beds – getting patients out of hospitals earlier and reducing readmits and revision surgeries. Hubly’s Drilling System is an easy and fast way to reduce costs and allow inexperienced doctors to have better outcomes. 

As such, our 5 year impact goals are:

1. Replace 30% of hand-crank drills for EVDs across the U.S.

2. Entered markets across the European Union, India, Middle East, and Latin America

3. Have second product to expand into orthopedic and O.R. neurosurgical drilling 

We plan on measuring impact by four metrics: (1) total number of intracranial access procedures our drill is used for; (2) complication rates for procedures in which our drill is used - the current solution yields a 20% failure rate in all intracranial access procedures and we plan to at least halve that; and (3) number of indications our drill is used in - we conservatively estimate 25 neurosurgical and orthopedic indications but this number is ever growing and we continue to expand our product pipeline; (4) number of hospitals Hubly is in which who do not have O.R. capabilities—this means they have no choice but to use the hand-crank drill. This is true of Critical Access Hospitals in the U.S. and in underserved areas.

We have interviewed 123 neurosurgeons, 26 orthopedic surgeons, and 16 hospital administrators. Overall, 104 of 123 neurosurgeons we interviewed think this is a huge problem and want Hubly for use at the bedside and the O.R.. Those who don’t just want to see more data! Which we are in the process of collecting with our hospital partners.

Activities: HED System is FDA Cleared and launches into U.S. Critical Access Hospitals, and hospitals in underserved areas which can or often reach full O.R. capacity. 

Outputs: Patients who need this life-saving procedure in a hospital without an O.R. available are able to receive the procedure with increased safety features and guidance. 

Short-term outcomes: Patients have reduced complication rates. ICU beds are freed sooner for next patient. 

Long-term outcomes: Patients live longer with better quality of lives. Hospitals have increased funding for additional procedures/equipment/etc.. With improved success rate, more physicians opt to perform the procedure for those who need it to live. 

Hubly’s completely unique features offer battery power, catheter and drill guidance to reduce the number of holes poked in the brain, and automatic stop to prevent accidental drilling into the brain. We’ve tested about 10 different methods of safe autostop and we determined that electrically monitoring current draw is by far the most effective. This feature has been tested extensively in human cadavers and live sheep with 100% success. 

Overall, Hubly is designed to replace this drill with a safer, easier to use option to save hospitals money, and most importantly to save lives.

Earlier prototypes of the HED System were tested in human cadavers at Northwestern Medicine and UMass Memorial Health. The full-production level HED System (pictured right) has been successfully tested in both live sheep and human cadaver studies at UCLA. We have also tested the production-level HED Systems extensively in bovine scapula benchtop testing. In these internal studies, the drill auto-stopped within the 2-millimeter margin product requirement every single time no matter the angle of drilling. We are now manufacturing drills for use in our FDA-required testing and expect to have data within March.

The LED (bottom photo) shines green when the user is pressing the trigger and drilling at the correct pressure level, prior to puncture. The LED shines red when the user is still applying pressure to the trigger, but the drill bit has punctured the medium. If the user is not pressing the trigger, the drill does not turn on. If the user does not apply minimum pressure, the motor turns on, but the LED does not.

Product demo with earlier prototype: 

When hiring full-time staff and contractors, we strongly prioritize diverse skill sets and perspectives. We are extremely committed to furthering diversity in entrepreneurship and medtech! We  host the Hubly Surgical Paid Internship program, which provides financial support, one-on-one mentorship, and unique neurotrauma R&D opportunities to socially and economically disadvantaged students: exclusively women and people of color. We also served as a 2021 host for the U.S. State Department Youth Leaders of the Americas Initiative (YLAI) and plan to continue. YLAI supports socially and economically disadvantaged founders across Latin America, and I (Casey) mentored and worked with a Chilena non-profit founder. I traveled to Viña del Mar, Chile of my own accord/not required by the program to work with this fellow female founder in person and still work with her today. I serve as a judge for YLAI as well as for the Halcyon Social Impact Incubator. I have also spent the past two years as a mentor and guest speaker for Northwestern University’s Propel Program, which provides mentorship and grant funding to first-time female entrepreneurs!

We are starting with a limited market release at our partner institutions (Northwestern Medicine, UCLA, Johns Hopkins, and Mount Sinai) so we can  conduct post-market clinical trials and actively gather customer feedback in the sales process. We will consistently be asking our customers: what are you hesitant about? What are you excited about? What information can we share that will ease your concerns and heighten your enthusiasm? What testing do you want to see? Then, we can use the answers to create the best possible documents and complete all necessary testing for expanding sales.

Then, we will expand sales to Critical Access Hospitals throughout the midwest where we're based. We will continually repeat the aforementioned user research in-person before selling cross-nationally. We will target neurotrama, skull base, and neurocritical care surgeons

We will market via papers and articles in the top neurosurgery journals: 'Journal of Neurosurgery' and 'Neurosurgery' and from exhibiting and/or attending the top conferences for us: American Association of Neurological Society, Congress of Neurological Surgeons, and in the beginning, National Neurotrama Symposium, National Neurocritical Care Conference, National Skull Base Society.

We have not yet entered the market with our drilling system, but plan to do so in Q4 2022 after gaining FDA clearance. Today’s bedside, hand-cranked drill kits sell for $1200/single-use disposable kit. HED System  will be sold at $2,000/single-use disposable kit with a 91% margin, though we will price match at launch with an 85% margin. We will sell directly to hospitals, first targeting urban centers with large neurosurgery residency programs. For purchases under 10 units, HED System is an operating expense and only needs a single neurosurgery attending to make the decision. For larger purchases, eventually up to 250 per institution per annum, HED System will need to go through VAC. Regardless,  HED System fits entirely under code 61210.

The estimated market size for intracranial access alone is $400M in North America and $2B globally — that's the maximum potential revenue we could get, with $2000/kit pricing. Our secondary market is in orthopedics, where the Hubly Ventri Drill can be useful for all orthopedic procedures for which over-drilling into nerves is a risk. This presents $8.4B of potential revenue in North America alone. In total, Hubly has a global market of $70B - which is ever growing as skull puncture becomes a safer procedure and as we expand our product line to address more neurosurgical and orthopedic indications.

We have raised $300k from Friends and Family and Alchemist Accelerator. And $900K pre-seed from River Valley Investors, First Fund VC, SWAN Impact Network, and Halcyon Impact Fund.

Additionally, we have won several grants and pitch competitions:

* Tulane Business Model Challenge [2022] 1st Place Winner of $75,000

* ASU.io Innovation Challenge [2022] Human Health Prize Winner of $50,000 

* Healthcare Safety Challenge [2021] Winner of Kicker Prize $3,000

* National AlphaLab Hardware Cup [2021] 1st Place winner of $5,000

* Start-Up Chile Demo Day [2020], 1st Place Most Investable Startup, winner of $3,300

* Start-Up Chile Demo Day [2020], 2nd Place Best Pitch

* Silicon Valley Entrepreneurs Demo Day [2020], 2nd Place

* VentureCat [2020] Semifinalist winner of $2,000

* VentureWell E-Team Stage 2 Grant [2020], winner of $20,000

* Startup Boost Demo Day [2019], 1st place winner

* VentureWell E-Team Stage 1 Grant [2019], winner of $5,000

* New Venture Championship [2019], 1st Place Lightning Round winner of $1,500

* PitchTX SXSW [2019] 3rd Place, winner of $5,000