EXPERTISE

Experience that comes with stories and scars.

We lean heavily into a specific market niche. We like it here.

Within that niche, we excel at helping teams across a handful of industries working on the development of regulated products with the kinds of budgets you’d expect of a younger company.

INDUSTRIES WE SUPPORT

We're particularly focused. We're ok with that.

Medical Devices
In Vitro Diagnostics (IVD)
Cell and Gene Therapies (CGT)
Biomarker Detection
Life Science Tools
General Wellness Devices

REGULATORY PATHWAYS

510(k)? PMA? CE?
Research Use Only?

While most of our clients are following traditional regulated pathways like 510(k), De Novo, PMA, and CE Marking - we also have deep experience with Life Science tools and Research Use Only (RUO) devices, Laboratory Developed Tests (LDTs) in CLIA labs, and products requiring current Good Laboratory and Manufacturing Practices (cGLP and cGMP).

TYPICAL FUNDING LEVEL

Grants and seeds through IPO.

We work almost exclusively with startups and young companies. Often our teams have first-time engineer or scientist founders and resources with little to no regulated product launch experience. Sometimes our teams have very experienced leadership but need peer support and extra help supplementing their internal teams.

You can't do everything at once and expect it to all be perfect. We develop infrastructure, processes, and tools to build only what you need, right when you need it. We call it "right-sizing" your processes and we're careful to not overwhelm you with too much too quickly. Plus, if this is your first time... we'll go out of our way to mentor and guide you through truly understanding why and how so you can feel confident doing it yourself next time.

Think of our specialized expertise as an adaptable toolset to help you scale your impact & business

Product Development

Product Development is tricky business. Anyone that thinks otherwise is fooling themselves. What's most important? Embracing fast failures with humility and giving yourself time to react. We love product development so much that we feel our URL prodct.dev is pretty much perfect. What we help with:

ISO 13485:2016 + 21 CFR 820:1996 savvy development processes
IEC 62304:2006+Amd1:2015 and IEC 82304-1:2016 for software projects
Requirements management
Product Realization planning and management
Verification & validation strategies and execution
Safety certification testing
Cyber security (e.g. IEC 81001-5-1:2021)
DHF, DMR, and CE Mark Technical File development
Total lifecycle product roadmapping

Risk Management

Critical to Product Development is the early adoption of a growth mindset rooted in modern Risk Management practices. In practice, Product Development and Risk Management are so intertwined that it's difficult to talk about one without the other. We're exceptional at blending the two, especially:

ISO 14971:2019 & ISO/TR 24971:2020 compliant processes
Risk Management training
Risk Analysis
Preliminary Hazard Analysis (PHA)
FMEA: dFMEA, pFMEA, sFMEA
Use Related Risk Analysis (URRA)
Fault Tree Analysis (FTA)

Operations

We'll help build and implement ISO 13485:2016 compliant infrastructure to scale as you grow. Use us as your flywheel. When things get busy, we'll show up.

CMO + Supplier selection & management
Design transfer to production
Production scale-up
Field Service process development + tool implementation
Service Manual creation and validation

Quality Management Systems

A robust Quality Management System (QMS) is the glue that holds everything together. We hear all the time, "Ugh. I hate QMS. It just slows me down and gets in the way." We hear you. We've been there too but QMS doesn't have to be like that. Let us show you how nimble and flexible a right-sized QMS can feel while still maintaining full compliance.

QMSR gap analysis, migration planning
Complete QMS development aligned with ISO 13485:2016 and secondarily with 21 CFR 820
Lean and light-weight QMS + efficient tools based on company maturity
QMS training
Leading Management Reviews
Internal auditing + gap assessments
External regulator interaction and audit support

Small Scale Manufacturing

Teams often need to build alpha or beta prototypes in relatively small numbers that don't warrant the attention of large Contract Manufacturing Organizations (CMOs), so they build the prototypes themselves. If you're a small team, your engineers are a precious commodity and tying them up building and troubleshooting systems isn't the best use of their skills. We use experienced engineering technicians to build your prototypes for you after learning from your team.

Small lot prototype manufacturing
Manufacturing work instruction development
Test fixture development + system qualification
Design for manufacture (DFM) assessment and feedback to design teams
Complete and fully traceable device (or lot) build history

Investor Support

Institutional VCs and angel investors rely on Prodct to dive deep technically and evaluate investments with unabashedly honest and straight-forward assessments of target portfolio companies. This might be for (1) diligence purposes before investment, (2) to help a portfolio company (already invested in) have a better chance of succeeding, or (3) to help a portfolio company work through challenging times.

Our evaluations are always hands-on. We meet the team in person, we spend time in their labs, we actually try the products ourselves. We've been known to even bring tools with us to disassemble devices to get a better look inside.
Focus is on detailed gap analyses on the product maturity, realistic plan from today through launch, and appropriate team + resources to deliver on that plan.

Our Philosophy

Our experience is hard-earned through decades of successes and failures. Through these experiences, we've learned three fundamental truths that guide how we share our expertise with you.

People build tech,
not the other way

We're a little different than other advisory organizations. Actually, very different. You'll be surprised by how intimately we get to know you, your team, and your project right from the start.

Mentors
matter

Experienced mentors and teachers are important to fuel growth. We invest as much time as it takes to make sure you understand why we do these things so you can do it on your own next time. We value our roles as guides on your journey.

Startup life
can be lonely

We get it. Many people struggle to really understand what you're going through. We're here for you now but we're also here for you long-term through launch. We'll authentically cheer you along the entire time, with full appreciation of how hard it is.