Let's discuss

I help MedTech companies scale with my 5-step method

I’m Ela — PhD biochemist with 15 years’ R&D experience bridging regulatory, technical, and market insights.

Let's discuss

Challanges

Your medtech is market-ready,
but scaling is too slow ?

As a medical device company with 10-50 employees. You have a promising product, but you're facing:

Generic market reports that can't tell you if you succeed

Without proper market analysis, you're betting millions on assumptions instead of knowing your real chances of success.

Generic market reports that can't tell you if you succeed

Without proper market analysis, you're betting millions on assumptions instead of knowing your real chances of success.

Generic market reports that can't tell you if you succeed

Without proper market analysis, you're betting millions on assumptions instead of knowing your real chances of success.

Teams working in silos and months of wasted work

When teams work separately, small missteps cause months of wasted work.

Teams working in silos and months of wasted work

When teams work separately, small missteps cause months of wasted work.

Teams working in silos and months of wasted work

When teams work separately, small missteps cause months of wasted work.

Stuck for too long with confusing regulatory requirements

Navigating MDR, 510(k), and CDSCO at once feels impossible with differing evidence and documentation

Stuck for too long with confusing regulatory requirements

Navigating MDR, 510(k), and CDSCO at once feels impossible with differing evidence and documentation

Stuck for too long with confusing regulatory requirements

Navigating MDR, 510(k), and CDSCO at once feels impossible with differing evidence and documentation

Success

What success looks like in medtech?

Clear probability of success

you know your chances before major investments

Aligned teams

R&D, regulatory and business working as one

Regulatory confidence

Approved pathways for EU, US and India

Market clarity

Pricing, positioning and access strategies that work

My solution

5 step methodology

I’m providing integrated analysis across five critical domains, using a proven methodology that quantifies success probability and eliminates costly team coordination failures.

Market readiness score

quantified assessment of market entry potential

Market readiness score

quantified assessment of market entry potential

Regulatory roadmap

coordinated strategy across all target markets

Team alignment

processes that eliminate costly silos

Team alignment

processes that eliminate costly silos

Investment criteria

clear metrics for funding decisions

Investment criteria

clear metrics for funding decisions

Market entry timeline

realistic milestones with buffer for unknowns

Market entry timeline

realistic milestones with buffer for unknowns

Working process

How do I guide the working process?

01. Deep dive analysis

Examinining your product data, market assumptions, and strategic goals across five critical domains.

02. Integrated assessment

My proprietary 5 step methodology reveals success probability by connecting product viability, regulatory requirements, and market dynamics.

03. Actionable roadmap

You get clear next steps, team alignment processes, and go/no-go criteria for smart investment decisions.

Your contribution:

2-3 hours initially, then weekly check-ins and document access.

Benefits

Complete picture to move forward

You'll know exactly whether your product will succeed before you invest more time and money.

Your teams will work together smoothly instead of against each other, making everything faster.

You'll get a complete picture of what it takes to enter EU, US, and India markets - no gaps or surprises.

CONTACT ME

How to start ?

Stop guessing your market potential. Every month of uncertainty costs you market position and investor confidence.

Initial consultation

30 minutes to understand your situation and give you best possible scenarios.

Fit assessment

Togather we determine if my approach matches your needs.

Project scoping

If we fit each other we will define success metrics and timeline.

reach me via e-mail: contact (at) empconsulting.pl

Expertise

Why companies work with me?

PhD biochemist turned medtech, I've been in the lab, dealt with regulators and launched products internationally, saved countless hours for my clients.

Boutique
approach

Working with max 3 clients at a time. You get my full attention, not junior analysts learning on the way.

Cross-functional integration

I speak the language of R&D, regulatory and business teams - bridging gaps that cause delays.

Milestone
billing

Pay as we progress, with clear KPIs at each stage.

Startups

Special support   for early-stage companies

Flexible engagement models for pre-revenue medtech startups. Let's discuss milestone-based arrangements that align with your funding stages.

I help MedTech companies scale with my 5-step method

Your medtech is market-ready,
but scaling is too slow ?