S7E22 Amelia Howe | Developing Medical Device Injectrodes for Pain Reduction, & Project Management Best Practices

Being an Engineer · 22 May 2026 · 52m · Episode 22

What this episode covers

Amelia Howe, a biomedical engineer and R&D project manager at COLTENE, discusses her career trajectory from nursing to biomedical engineering and her role as the first employee at Neuronoff, where she helped develop the Injectrode neuromodulation device. She details the technical challenges of creating a removable, injectable electrode for chronic pain relief, including validation testing in animal models and navigating FDA submissions. Howe also shares her project management philosophy, emphasizing the importance of clear communication, written records, and resource allocation using tools like Asana, while launching her own consulting firm, Chrysalis Business Consulting.

Mentioned

Companies
Neuronoff, COLTENE, Chrysalis Business Consulting, Pipeline Design & Engineering
Products
Injectrode
Tools
Asana, Google Chat, Wrike

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 49m

    Pros & Cons of Being a Physician turned MedTech Inventor

    Dr. Amy Baxter, CEO and founder of Pain Care Labs, discusses her journey from emergency physician to MedTech inventor, detailing the creation of Buzzy® and VibraCool® devices to manage pain without opioids. She explains how her clinical observations led to combining cold therapy with mechanical stimulation, navigating the rigorous ISO 13485 regulatory process and securing NIH SBIR funding to bring the products to market. Baxter advises physician inventors to fall in love with the problem rather than the solution, emphasizing the importance of understanding regulatory pathways, branding, and avoiding unnecessary NDAs. The episode highlights the specific challenges of developing pain management devices, including subjective efficacy metrics and the long timeline from prototype to commercial launch.

  • Embedded.fm · 1h 04m

    305: Humans Have a Terrible Spec Sheet

    Amanda Wozniak, a principal engineer at Amazon Robotics with a background at Analog Devices, the Wyss Institute at Harvard, and NxStage, discusses her career path from semiconductor design to biomedical engineering and robotics. She explains the critical gap between academic theory and practical engineering, highlighting how parasitics and non-ideal component behavior often cause circuit failures that textbooks ignore. Wozniak also details the challenges of navigating FDA regulatory processes for medical devices and the importance of establishing robust quality systems early to avoid bureaucratic busywork. Finally, she addresses the realities of being a woman in tech, offering advice on handling sexism, avoiding burnout, and recognizing that engineering is fundamentally a team sport rather than a solo endeavor.

  • Global Medical Device Podcast · 40m

    #355: Mastering the Pitch: MedTech Innovations from Concept to Market

    Blythe Karow, COO at Neurogeneces and former president/COO at Evren Technologies, shares her extensive experience pitching to investors, including securing an FDA breakthrough designation for Evren's spinal cord stimulation device. She emphasizes the importance of tailoring pitches to specific audiences, starting with the problem in the voice of the payer, and managing team dynamics during presentations. Karow also discusses the emotional aspects of pitching, such as handling nervousness and gender dynamics, while advising founders to practice extensively and utilize resources like Springboard Digital Health Innovation Program.

  • Global Medical Device Podcast · 43m

    #381: MedTech Advice from an Accidental Entrepreneur

    Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, explains how she transitioned from a biomedical engineering PhD to an accidental entrepreneur with vascular surgeon Dr. Adam Power. They developed the COBRA-OS, a bleeding control device used in trauma care, military settings, and Formula One race tracks. Parekh discusses the critical role of passion in overcoming challenges, the art of pitching to secure millions in funding, and the importance of founders remaining the ultimate experts on their device's regulatory pathway rather than relying blindly on consultants.

  • Let's Combinate · 1h 30m

    009 - “Cutting Through the Noise” with Charles Ventura

    Charles Ventura, CEO of Hemotek Medical and President of Ventura Solutions, discusses his career transition from biomedical engineering at Baxter Healthcare to founding his own companies. He details the development of the V Needle, a safety device for dialysis to prevent venous needle dislodgement, emphasizing the importance of systems engineering, risk management (ISO 14971), and user-centric design. Ventura also provides strategic advice for early-career engineers, highlighting the necessity of mastering regulatory frameworks like FDA 21 CFR Part 820 and ISO 13485, as well as practical skills in statistics and project management to secure their first roles.

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Being an Engineer. The episode itself belongs to its publisher.