About
Specialized Clinical and Medical Affairs strategy, complementary to a CRO.
Regenesis Scientific Strategy is led by Stephanie Washburn, PhD, Principal Consultant. She leads a team of consultants from junior to senior level, with exclusive partners in biostatistics, reimbursement, grant writing, and regulatory. Engagements run from first evidence plan through commercial launch.
Background
Stephanie Washburn has nearly twenty years in medical-device Clinical and Medical Affairs across Class I through III programs.
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.
Regenesis Scientific Strategy exists so lean device companies can have Clinical and Medical Affairs functions before they create a department.
The office is in Southlake, Texas, near Dallas–Fort Worth International Airport.
Path
From first evidence plan through commercial launch.
Abbott
SCS and PNS
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
Field and clinical leadership
MSL for gammaCore (nVNS for migraine and cluster headache) — field medical work for a commercial neuromodulation therapy, including scientific exchange 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 stood up while the trial was executed.
Early-stage SaMD start-up
Clinical infrastructure
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
Regenesis Scientific Strategy
Independent Clinical and Medical Affairs consulting for medical device companies that need that function before they create a department. Women-owned.
Partnerships
Exclusive partners, when the work needs them.
Clinical and Medical Affairs stays with Regenesis Scientific Strategy. Biostatistics, reimbursement, grant writing, and regulatory come in through exclusive partners — not as a second vendor process the company has to manage.
01
Biostatistics
Sample size, statistical analysis plans, adaptive design, and interim analysis. Regenesis Scientific Strategy leads trial data analytics and insights on live studies.
02
Reimbursement
Payer evidence strategy so the protocol collects what payers will require — specified before first enrollment, not after.
03
Grant writing
Non-dilutive funding, in a partnership model. Equity fundraising is out of scope.
04
Regulatory
Regulatory strategy and submission support through exclusive partners. We do not replace the company's regulatory representative.
Who this is for
Medical device companies with a defined clinical evidence or Medical Affairs need.
A fit
- A founder who needs to know who belongs in the first clinical, regulatory, or CRO conversation.
- A CMO or CEO whose clinical plan and claims are not aligned.
- A medical device program approaching IDE, pivotal, 510(k), or PMA.
- A company that needs treating physicians prepared with evidence before commercial launch.
- A feasibility or PMCF study that has stalled.
Not a fit
- A request to execute a large multicenter trial, or to serve as the regulatory representative. Large study execution sits with a CRO.
- General medical device commercial, branding, or fundraising strategy — except non-dilutive grants, in partnership.
- Pharmaceutical Clinical or Medical Affairs.
- Prototype or product-design work.
Start a conversation
If you need Clinical and Medical Affairs strategy, write.
A 15- to 30-minute call is enough to assess fit. No deck required.