Christie Johnson Email & Phone Number

Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors are deeply experienced medical device developers and manufacturers who provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments.Prodct creates bespoke development, risk management, manufacturing, and quality strategies aligned with 21 CFR part 820, ISO 13485:2016, IEC 62304:2006, and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary.

Boston, Ma, Us

myBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights.

Indianapolis, In, Us

I help startups and small firms navigate concept-to-launch Product Development and Quality. I create customized, ISO 13485:2016 and 21 CFR Part 820 compliant Quality Management Systems (QMS), remediate QMS-based regulatory notices, and author Design History Files (DHF) and ISO 14971:2019 compliant Risk Management Files (RMF). I often bridge the gap between engineering teams and executive management, helping to translate and communicate requirements to stakeholders. My coaching highlights risk-focused decision making and process implementation wherever possible.

Charlotte, North Carolina, Us

I led the design & development of three single-use kits for therapeutic ultrasound systems from concept origination through product verification, validation, creation of quality procedures, launch, and initial commercial use in the US. I managed multiple major, cross-functional projects requiring 10,000 hours each and a team of 12, including marketing, sales, engineering, quality, manufacturing, and supply chain. I also enjoyed coaching multiple young engineers new to medical devices. Through owning the risk management files compliant with ISO 14971, I kept user/patient safety at the forefront and instilled a patient-centric culture in my team.

Marlborough, Ma, Us

I led design and product quality for biopsy device ($50 MM annual revenue), including evaluating complaints, all project documentation, redesigning for DFM/cost reduction ($75k annual savings) & product transfer to Costa Rica. I provided technical support to regional sales specialists, clinical education specialists, and manufacturing. Working with the world-class team at Hologic, I learned what it looks like to keep a patient-centric focus throughout development and manufacturing-- and to keep my eyes on Risk Management as a guide in design, process development, and customer feedback.

Cincinnati, Oh, Us

In this role at GE, I analyzed the design, manufacturing, test, and integration required to define and support the development of the oil system for the F136 fighter engine used on the Joint Strike Fighter and coordinated multiple component rig tests at once, managing multiple locations, suppliers, and budgets. This role encouraged me to dive deep in my niche area, which led me to understand my strength of having a system-perspective and holistic view of problems.

I found my love of medical device development in my last project at Purdue University as a senior, designing, fabricating, fitting, a custom prosthetic leg for a 12-year-old with unusual leg geometry. The project was a simple four-bar linkage that extended his residual limb and allowed him to ride a bike for the first time ever. It was all over for me when he flashed the huge smile pedaling on the bike trainer the first day he put on his new leg. I learned some design skills, used a few machines and tools... but this project pulled my heart into the business of helping people and improving quality of life. It took a few years after graduation to get back to medical devices, but this is where the love affair started and I will be forever grateful to him and to Purdue for teaching me to use my skills for good.

As a Resident Assistant, I had the opportunity to live alongside and serve the women of Windsor Hall at Purdue University. We studied, formed healthy habits, learned about inclusivity, solved crises, talked about poor choices, celebrated good choices, cried, --but mostly laughed together.

B.S, Mechanical Engineering

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