About
Regenesis Scientific Strategy is a team of consultants from junior to senior level, led by a Principal Consultant, with exclusive partners in biostatistics, reimbursement and market access, and regulatory. Engagements run from first evidence plan through commercial launch. The office is in Southlake, Texas, near Dallas–Fort Worth International Airport.
Team
Consultants from junior to senior level staff the engagement. A Principal Consultant sets the plan, manages the engagement, and is accountable for delivery.
Founding Principal Consultant
Stephanie Washburn has nearly twenty years in medical device Clinical and Medical Affairs across Class I through III programs. She works as Principal Consultant and leads the team.
At Abbott (formerly St. Jude Medical Neuromodulation) she supported SCS and PNS programs — IDE and post-approval work, 510(k) and CE support, and a multicenter sham-controlled occipital nerve stimulation trial in chronic migraine, published in Cephalalgia.
As VP, Clinical and Medical Affairs at Spark Biomedical, she took a neurostimulation program for opioid withdrawal from Pre-Sub through FDA clearance and stood up the clinical department while the trial was executed.
She was an MSL for electroCore / gammaCore, supporting nVNS for migraine and cluster headache — field medical work for a commercial neuromodulation therapy, including scientific exchange with treating clinicians.
She was Head of Clinical and Medical Affairs Strategy at an early-stage SaMD start-up, building the clinical and evidence infrastructure the company needed before it had a Clinical and Medical Affairs department.
Path
Abbott
Clinical strategy and Medical Affairs at Abbott (formerly St. Jude Medical Neuromodulation) for spinal-cord and peripheral-nerve stimulation. IDE and post-approval work, 510(k) and CE support, and a multicenter sham-controlled occipital nerve stimulation trial in chronic migraine, published in Cephalalgia.
electroCore / Spark
MSL for gammaCore (nVNS for migraine and cluster headache) — field medical work for a commercial neuromodulation therapy, including scientific discussions with treating clinicians. Then VP, Clinical and Medical Affairs at Spark Biomedical: a neurostimulation program for opioid withdrawal, taken from Pre-Sub through FDA clearance, with the clinical department built while the trial was executed.
Early-stage SaMD start-up
Head of Clinical and Medical Affairs Strategy at an early-stage SaMD start-up — building the clinical and evidence infrastructure the company needed before it had a Clinical and Medical Affairs department.
Today
Founding Principal Consultant at Regenesis Scientific Strategy, leading a team of consultants for medical device companies that need Clinical and Medical Affairs before they create a department. Women-owned.
Partnerships
Clinical and Medical Affairs stays with Regenesis Scientific Strategy. Biostatistics, reimbursement and market access, and regulatory come in through exclusive partners.
Reimbursement and market access
Reimbursement and market access strategy for medical devices. Coding, coverage, payment, and payer evidence considered before first enrollment.
Poplar Access Advisors02
Biostatistics
Sample size, statistical analysis plans, adaptive design, and interim analysis. Regenesis Scientific Strategy leads trial data analytics and insights on live studies.
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Regulatory
Regulatory strategy and submission support through exclusive partners, working with the company's regulatory representative.
Vision
Today we provide Clinical and Medical Affairs strategy, preclinical development, fundraising strategy, and strategic and fractional leadership. When a program also needs biostatistics, reimbursement and market access, or regulatory work, we bring in exclusive partners.
The vision is that a medical device company can hire Regenesis Scientific Strategy for the whole development path — not a separate vendor for every function. You work with us. We coordinate the rest.
Concurrent work
The columns are development phases, not a sequence you finish one at a time. R&D, preclinical, clinical, regulatory, marketing, and access run together and depend on each other. Clinical Evidence Strategy Planning (CESP) runs across all of them — including HCP input we identify and manage — so those workstreams stay aligned.
Do not give a trial to a CRO and step away. The company still needs experienced trial management of its own — someone who knows the regulations and represents the sponsor. That is how a study stays on track and on budget. We work on the sponsor side. Small studies we can run. Larger studies we run with a CRO.
CESP
A process, not a stage. It runs at the same time as R&D, preclinical, and clinical work.
Who this is for
Contact
A 15- to 30-minute call is enough to see whether we are a fit.