Work Experience

Deep Brain Innovations LLC (NDI Medical affiliate company)

VP, Clinical and Regulatory Affairs

Highlights:

• Planned and executed of a clinical trial to evaluate an innovation in deep brain stimulation (DBS) for the treatment of Parkinson’s disease

2018-2024

SPR Therapeutics and Checkpoint Surgical (NDI Medical affiliate companies)

Regulatory Consultant

Highlights:

• Supported regulatory, clinical, and quality projects

NDI Medical LLC

Vice President, Regulatory Affairs and Quality Systems

2002-2014

Highlights:

• First employee and executive in medical device company specializing in neurostimulation products (active implantable, percutaneous, and intraoperative technologies)

• Conducted strategic planning for business, product development, clinical studies, quality, and regulatory objectives.

• Wrote successful state and federal grant applications for product development and clinical studies, resulting in substantial non-dilutive funding for the company

• Built and led company Regulatory and Quality functions

• Co-designed and conducted company clinical trials and obtained required regulatory approvals

• Obtained CE Mark, Canadian, Australian, etc. marketing approval for company products around the world

• Developed quality system procedures

NeuroControl Corporation

Senior Project Director

Director, Clinical Studies and Regulatory Affairs

Manager, Clinical Studies and Regulatory Affairs

Clinical Study Manager

2001-2002

1998-2001

1995-1998

1994-1995

Highlights:

• Early (original 5) employee for a company specializing in implantable neurostimulation medical devices to restore function for persons with spinal cord injury

• Co-designed and led three multi-center (and multi-national) clinical trials and obtained required regulatory approvals

• Wrote applications and achieved Food and Drug Administration and international approvals for first-of-their-kind active implantable medical devices

Cleveland FES Center Multi-center Study Coordinator

US Food and Drug Administration, Scientific Reviewer Neurological Devices Branch, CDRH

1992-1994

1987-1989

Education

Case Western Reserve University

MS Biomedical Engineering

Cleveland, OH

1993

Duke University

BS Biomedical Engineering

1. Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53.

2. Rauck RL, Cohen SP, Gilmore CA, North JM, Kapural L, Zang RH, Grill JH, Boggs JW. Treatment of post-amputation pain with peripheral nerve stimulation.  Neuromodulation. 2014 Feb;17(2):188-97.

3. Kennelly MJ, Bennett ME, Grill WM, Grill JH, Boggs JW.  Electrical stimulation of the urethra evokes bladder contractions and emptying in spinal cord injury men: case studies. J Spinal Cord Med. 2011;34(3):315-21.

4. Kennelly MJ, Arena KC, Shaffer N, Bennett ME, Grill WM, Grill JH, Boggs JW.  Electrical stimulation of the urethra evokes bladder contractions in a woman with spinal cord injury.  J Spinal Cord Med. 2010;33(3):261-5.

5. Goldman HB, Amundsen CL, Mangel J, Grill JH, Bennett ME, Gustafson KJ, Grill WM. Dorsal genital nerve stimulation for the treatment of overactive bladder symptoms. Neurourol Urodyn, 2008. 27(6): p. 499-503.

6. Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP.  Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12 month follow-up of a multiple center, randomized clinical trial.  Am J Phys Med Rehabil. 2005 Nov;84(11):832-42.

7. Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular Neuromuscular Electric Stimulation for Poststroke Shoulder Pain: A Multicenter Randomized Clinical Trial. Arch Phys Med and Rehab, Vol. 85, 695-704, May 2004.

8. Creasey GH, Grill JH, et al., An Implantable NeuroProsthesis for Restoring Bladder and Bowel Control to Patients with Spinal Cord Injuries:  A Multicenter Trial, Arch Phys Med Rehab, Vol.82, November 2001.

9. Peckham HP, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulchahey MJ, Carroll S, Hentz VR, Wiegner A, Efficacy of an Implanted Neuroprosthesis for Restoring Hand Grasp in Tetraplegia:  A Mulitcenter Study, Arch Phys Med Rehab, Vol.82, No.10, October 2001.

10. Wuolle, KS, Van Doren, CL, Bryden, AM, Peckham, PH, Keith, MW, Kilgore, KL, and Grill, JH, Satisfaction with and Usage of a Hand Neuroprosthesis, Arch Phys Med Rehab, 80(2):206-213, February 1999.

11. Grill, JH, and Peckham, PH, Functional Neuromuscular Stimulation for Combined Control of Elbow Extension and Hand Grasp in C5 and C6 Quadriplegics, IEEE Transactions on Rehabilitation Engineering, Vol.6, No.2, June 1998.

Grants

“Neuromodulation for Stroke Shoulder Pain”

SBIR 1R43NS066524-01A1

PI:  Maria Bennett

Period: 8/5/10 – 3/31/12

“Ohio Neurostimulation and Neuromodulation Partnership Continuation”

Biomedical Research and Commercialization Program, State of Ohio

Co-PI: G.Thrope/P. H. Peckham

“Electrical Treatment of Reflex Incontinence”

SBIR 2R44AG021851-03A2

PI:  Geoffrey Thrope

Period 4/1/03 – 7/31/09

“Neurostimulation for elbow extension in tetraplegia”

SBIR 1R43HD049960-01A1

Period:  8/1/06 – 7/31/08

“Peripheral Nerve Stimulation for Urge Incontinence”

SBIR 1R43AG022292-01

Period: 9/30/03 – 8/31/05

Ohio Biomedical Research and Technology Transfer Commission

Period:  7/1/03 - 6/30/06

“Implantable Neuromodulation System for Urinary Incontinence”

Ohio Third Frontier Action Fund

Period: 1/1/04 – 12/31/05

Foundation and local government grants for NC

non-profit hunger relief organizations (more info on request)

2015-present

Patents

1. Mrva JJ, Strother RB, Thrope GB, Grill JH, Bennett ME, inventors; Medtronic Urinary Solutions, Inc., assignee. Systems and methods including lead and electrode structures sized and configured for implantation in adipose tissue. United States patent US 8,649,870. 2014 Feb 11.

2. Bennett ME, Grill J, Lechman TE, Mrva JJ, Sakai JL, Strother RB, Thrope GB, Zmina TM, inventors; Medtronic, Inc., assignee. Stimulation of dorsal genital nerves to treat urologic dysfunctions. United States patent US 8,467,875. 2013 Jun 18.

3. Mrva, JJ, Strother RB, Thrope GB, Grill J, Bennett ME, inventors; Medtronic Urinary Solutions, Inc., assignee. Methods for electrical stimulation of nerves in adipose tissue regions. United States patent US 7,865,250. 2011 Jan 4.

4. Bennett M, Strother RB, Grill J, Mrva JJ, Zmina T, Thrope GB, inventors; Medtronic Urinary Solutions, Inc., assignee. Systems and methods for bilateral stimulation of left and right branches of the dorsal genital nerves to treat dysfunctions, such as urinary incontinence. United States patent US 7,565,198. 2009 Jul 21.

5. Mrva JJ, Strother RB, Thrope GB, Grill J, Bennett M, inventors; NDI Medical, LLC., assignee. Method for affecting urinary function with electrode implantation in adipose tissue. United States patent US 7,343,202. 2008 Mar 11.