We were lucky to catch up with Sequita Lindsey recently and have shared our conversation below.
Sequita, appreciate you joining us today. We love asking folks what they would do differently if they were starting today – how they would speed up the process, etc. We’d love to hear how you would set everything up if you were to start from step 1 today
If I were starting my business over, I would focus more on early user feedback and iterate quickly based on that feedback. The Medical Device Industry is fast pace and regulations change all the time. That means the needs of our clients are constantly changing.
Additionally, I would prioritize building a strong community around the service we are providing from the beginning, as engaged users can provide valuable insights and support.
Finally, I would emphasize the importance of scalability and flexibility in the business model to adapt to the ever changing market conditions and opportunities.
To achieve my current state faster with less capital, I would focus on lean methodologies and prioritize the most critical aspects of growth. This would involve:
1. Bootstrapping: Maximizing efficiency and minimizing expenses by using existing resources.
2. Strategic Partnerships: Leveraging partnerships and collaborations with complementary businesses or influencers to expand reach and access resources without significant upfront investment.
3. Organic Growth: Prioritizing organic growth strategies such as content marketing, SEO, Networking Events, and social media engagement to build a loyal user base without relying heavily on paid advertising.
4. Focus on Revenue: From the outset, emphasizing revenue generation through early monetization strategies, whether through product sales, subscriptions, or other revenue streams, to sustain and fuel growth.
By adopting these approaches, I could accelerate progress while conserving capital and resources.
Awesome – so before we get into the rest of our questions, can you briefly introduce yourself to our readers.
Hello, I’m Sequita Lindsey, and I’m the founder of Lindsey Regulatory Affairs Consulting, LLC (DBA, LRA Consulting). I began my journey in the Medical Device industry within manufacturing and worked my way into Regulatory Affairs as a Regulatory Affairs Associate. Beginning as an entry level RA Professional laid the foundation to understand Regulatory 101. It shaped me into the person I am today, with a passion for patient safety. I obtained my Bachelor’s degree in Interdisciplinary Studies with a concentration in Integrated Studies from Winston-Salem State University. I expanded my education by obtaining my master’s degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. I am also a Regulatory Affairs Certification Holder in Global Scope from the Regulatory Affairs Professional Society.
As the CEO and Principal Consultant of Lindsey Regulatory Affairs Consulting, LLC, I have been providing strategic and operational guidance to medical device companies in the global market for over five years. With more than 17 years of regulatory affairs experience in the biomedical and medical device industry, I have a proven track record of successfully managing complex projects and submissions across various regulatory jurisdictions and product categories.
My core competencies include developing and directing regulatory strategies for earliest possible approvals, translating regulatory requirements into practical and workable plans, ensuring compliance with global regulatory standards and best practices, and leading and managing regulatory teams and resources. I have extensive knowledge and expertise in the European Union Technical Files/Design Dossier, MDD to MDR transition and compliance, FDA regulations, and ISO 13485 standards. I also have a strong background in orthopedics and cardiovascular devices, having authored the first Investigational Device Exemption (IDE) submission to FDA for a novel biodegradable stent. My mission is to enable medical device innovation and advancement by delivering high-quality and efficient regulatory affairs solutions to my clients.
Do you have any insights you can share related to maintaining high team morale?
I treat my team like family. We have a few things we have implemented at LRA Consulting:
1. Clear Communication amongst everyone
2. Recognition and appreciation often
3. Empowerment around tasks and responsibilities
4. Professional and Personal development
5. Work-life balance and promoting wellness
6. Lead by example
7. Feedback and support in all areas
How do you keep in touch with clients and foster brand loyalty?
We prioritize regular communication, personalization, excellent service, collect feedback, and build/foster relationships with our clientele from beginning to end.
Contact Info:
- Website: https://www.lracs.com/
- Instagram: https://www.instagram.com/lra_consulting/
- Facebook: https://www.facebook.com/LRAConsulting/
- Linkedin: https://www.linkedin.com/company/lraconsultingllc/?viewAsMember=true
- Twitter: https://twitter.com/regulatoryllc?lang=en
Image Credits
New Depth Creations, LLC – Jared Caldwell