Edwin Lindsay
Principal Consultant & Managing Director, CS Lifesciences
Edwin Lindsay is principal consultant and managing director at CS Lifesciences, a regulatory, quality, and clinical consultancy working across the UK, Ireland, and the US. A micro and molecular biologist by training, he has worked in life sciences and medical device regulatory affairs for more than 20 years, guiding companies through FDA 510(k), IDE, and PMA pathways as well as CE Mark and Design Dossier approvals.
He has served as an outsourced quality and regulatory department for companies from startup through to acquisition, including Current Health’s exit to Best Buy, and has particular depth in in-vitro diagnostics and pediatric devices. Earlier in his career he helped establish the Scottish Cord Blood Bank and a series of stem cell banks with the Scottish National Blood Transfusion Service. He also lectures on medical device regulation at the University of Strathclyde and the University of Glasgow.
Lindsay appeared on Open Door Salon alongside Christian Espinosa, founder and CEO of Blue Goat Cyber, for a conversation with host Lori Ellis on the three forces that make or break a medtech launch. He drew the line from cybersecurity to patient safety, explained why studies that satisfy the FDA can still fail the payer, and made the case that reimbursement strategy has to enter product design at the concept stage rather than after clearance.
Frequently Asked Questions About Edwin Lindsay
Who is Edwin Lindsay?
Edwin Lindsay is principal consultant and managing director at CS Lifesciences, a regulatory, quality, and clinical consultancy working across the UK, Ireland, and the US. A micro and molecular biologist by training, he has worked in life sciences and medical device regulatory affairs for more than 20 years. Earlier in his career he helped establish the Scottish Cord Blood Bank and a series of stem cell banks with the Scottish National Blood Transfusion Service.
What does Edwin Lindsay do at CS Lifesciences?
Edwin Lindsay runs CS Lifesciences as its principal consultant and managing director. The firm is a regulatory, quality, and clinical consultancy working across the UK, Ireland, and the US. He has served as an outsourced quality and regulatory department for companies from startup through to acquisition, including Current Health’s exit to Best Buy, and has particular depth in in-vitro diagnostics and pediatric devices.
What regulatory pathways does Edwin Lindsay work on?
Edwin Lindsay guides companies through FDA 510(k), IDE, and PMA pathways, along with CE Mark and Design Dossier approvals. That work spans more than 20 years in life sciences and medical device regulatory affairs. He also lectures on medical device regulation at the University of Strathclyde and the University of Glasgow.
What does Edwin Lindsay say about medical device cybersecurity?
Edwin Lindsay draws the line from device cybersecurity to patient safety. On Open Door Salon, on why medical-device cybersecurity is a patient-safety question, he said: “It's not about stealing the data. It's what harm can I cause a patient.” He also said of investors: “Many investors still think cybersecurity in terms of medical devices is about data protection. It's really about patient safety.”
What does Edwin Lindsay say about reimbursement?
Edwin Lindsay holds that reimbursement strategy has to enter product design at the concept stage. On Open Door Salon, on planning for reimbursement and the market, he asked: “You may be FDA ready, but are you going to be market ready as well?” He has explained why studies that satisfy the FDA can still fail the payer, a view built on more than 20 years guiding devices from concept through clearance and launch.
On Open Door Salon
“FDA, Payers & Hackers: The Three Forces That Make or Break a Launch”
Christian Espinosa & Edwin Lindsay · July 8, 2026
Episode page & show notes on Open Door Salon
In this episode
- Where a medtech launch actually breaks first
- The questions investors should be asking
- Patient safety, not data protection
- China, supply chains, and subcontractor cyber controls
- What FDA readiness actually means in 2026
- When reimbursement strategy should enter product design
- The most expensive reimbursement mistake
- What pulled him into healthcare
Topics
Watch on Open Door Salon
Open Door Salon brings life-sciences leaders into candid conversation. Every Monday, the week's takeaways land in your inbox.
Subscribe on Substack →