Great diagnostics
don’t sell themselves.
We help them travel.

Tusinski MedTech Partners is an independent business development and market-access partner for IVD and medtech manufacturers. We plan the regulatory route, build the commercial case and connect you with the right partners in each market.

Who we work with

Companies with a test or device that works, with aspirations and markets it has not reached yet.

  • Manufacturers entering Europe

    IVD and medtech makers from outside the EU who need an IVDR route, a notified-body plan and reliable European partners.

  • European companies going global

    Diagnostics companies with a CE-marked portfolio looking for distributors and registrations in the Middle East, Africa, Latin America and Asia.

  • Service providers in diagnostics

    CROs, laboratories and regulatory firms that need an external business development partner to find manufacturer clients and look after them.

  • Longevity and healthspan diagnostics

    Companies developing or launching biomarker, epigenetic or home-sampling tests for clinics and consumers.

Services

Four areas that follow how a diagnostic product actually reaches the market. Most engagements combine two or three of them.

Diagnostics & IVD

Make the product ready to sell.

Product and portfolio strategy
Which assays, formats and claims to take forward, and in what order. Lifecycle, pricing and return-on-investment analysis for CLIA, ELISA, lateral flow (colloidal gold, latex, TR-FIA) and point-of-care readers.
R&D and technical support
Experienced input on assay design, reader integration, specimen and matrix questions, and instructions for use, from the first prototype to transfer into production.
Validation and evaluation studies
Analytical studies such as precision, linearity, matrix comparison and interference, designed with partner CROs and run in validation laboratories, so the results can go straight into technical documentation.

Commercialisation & growth

Build the case and the plan.

Market-entry feasibility
A written assessment of target markets, regulatory requirements, pricing and channel options, with named target partners for each region.
Launch, pricing and positioning
Intended-use positioning, price architecture, a launch plan and sales materials that distributors can actually use.
External business development partner
We act as your business development lead on a monthly retainer: finding and qualifying partners, running first meetings and looking after the accounts afterwards.

Partnerships & market access

Open the right doors.

Regulatory route
IVDR and CE strategy, from intended purpose and risk class to notified-body submission, prepared with trusted regulatory partners and CROs. FDA pre-submissions through the same network.
Distributor and partner introductions
Selection, introductions and first negotiations with distributors and laboratories in Europe, the Middle East, Africa, Latin America and Asia.
Sourcing and manufacturing partners
Access to raw-material, consumables and contract manufacturers worldwide, for a new product or a second source.

Longevity & healthspan diagnostics

Bring healthspan testing to market on solid evidence.

Test development and validation
Biomarker panels, epigenetic and miRNA tests, and dried-blood-spot home sampling: choosing the assay, running analytical validation and finding the right laboratory partners.
Market access
Which regulatory category applies (professional use, self-test or research use only), claims that hold up under IVDR, and routes to market through clinics, laboratories and direct to consumers.
Evidence review
An independent check of what a test measures and how reliably it measures it, before it reaches doctors or consumers.

How we work

Every engagement starts with a short call and a written scope, so both sides know what will be delivered and when.

  1. Discovery call

    Fifteen minutes, complimentary. You describe the product, its status and your target markets. We tell you plainly whether we can help.

  2. Assessment and scope

    We review the documents you share under NDA and propose a written scope: deliverables, timeline and monthly hours.

  3. Route plan

    Regulatory pathway, commercial plan and target partners, agreed with your team.

  4. Open doors

    Introductions, meetings and follow-up until the first partners are signed, then ongoing care of those accounts.

Where we can take your product

Distributor and laboratory contacts built over years of running a global diagnostics portfolio.

  • Europe

    EU markets and the United Kingdom

  • Middle East

    United Arab Emirates, Saudi Arabia, Türkiye

  • Africa

    Nigeria, Kenya, Tanzania, Uganda, South Africa

  • Latin America

    Argentina, Mexico

  • Asia

    India, the Philippines, Taiwan, Thailand, Indonesia, Vietnam

Behind the network

  • Validation laboratories
  • CROs preparing IVDR and FDA dossiers
  • Notified-body and regulatory partners
  • Raw-material and consumables suppliers
  • Contract manufacturers
  • Distributors and laboratory networks

A scientist who helps make deserving diagnostics fly

Rafał Tusiński is an immunologist moving from the lab bench to the commercial world of in-vitro diagnostics, first launching CLIA immunoassays across European markets, then managing a global CLIA, ELISA, immunohistochemistry and point-of-care portfolio for a multinational IVD group.

In that role he worked with sixteen regional sales directors and R&D sites on three continents, led registration work from IVDD to IVDR, and owned pricing, return-on-investment analysis and launch plans.

Today he works with manufacturers who already have a good product and need it to reach the right markets.

What colleagues say

Recommendations from people who have worked directly with Raf across global product management, R&D, clinical adoption and commercial teams.

Esther Hidalgo, PhD

Strategic Partnerships Manager at Abbott

October 8, 2026 · Worked with Raf on the same team

I worked with Raf at Erba Mannheim, where he ran the global product portfolio across CLIA, ELISA, immunohistochemistry and point-of-care testing. As a global product manager for urinalysis I worked with him on multiple projects worldwide.

What stood out was how he connected the parts of a diagnostics business that usually don't talk to each other. He took what our regional sales teams were hearing from customers, turned it into clear requirements for R&D sites on three continents, and made sure regulatory, pricing and launch plans were ready when the product was. Through the move from IVDD to IVDR he worked closely with regulatory affairs without losing sight of the commercial picture.

He is an immunologist by training, and it shows: he could question an assay's performance data with R&D and then build the business case for senior management, in the same week and with the same clarity.

If you have a strong diagnostic product that isn't reaching its market, Raf is the person I'd call.

Saqib Ashraf

Product Specialist at DiaSorin

October 16, 2026 · Reported to Raf directly

Some of the most useful lessons of my career happened in hospital labs around the UK, standing next to Raf in front of an analyser that wasn't behaving.

He hired me as a Product Specialist at DiaSorin and took me through training and induction himself. Then we hit the road. Watching him troubleshoot was a lesson in method: rule out the obvious first, isolate the cause, explain it to the lab team in plain words, and leave them confident in the system.

He taught with real patience and never made a new starter feel out of his depth.

And he's great company on a long drive between labs.

He was always patient an attentive to detail and always finding a solution that worked best for the customer and DiaSorin

It was truley a wonderful learning period and also educational to see how a commercial world looks like outside of the lab.

Thanks Raf for making the transition from a lab into the commercial world

Carlos Ávila García

International Marketing Manager at Erba Mannheim

October 8, 2026 · Worked with Raf on the same team

When Raf and I worked together at Erba Mannheim, I was Global Product Manager for Clinical Chemistry, and we ran our portfolios side by side for almost 3 years.

As a peer, I valued how rigorous he was on the business side of product management. His business cases, pricing and ROI analyses were built on real market data, and he was as comfortable presenting them to our CEO as defending them with the regional sales directors. He also brought new products and partners into the group, taking them from first evaluation through negotiation to launch.

Raf is generous with his knowledge and easy to work with across portfolios. Our immunoassay and clinical chemistry offers often went to the same laboratories, and he always thought about the customer's whole lab, not only his own assays.

Any diagnostics company that needs someone to shape a portfolio and take products to market internationally would be in good hands with him.

Shaun Wake

National Sales Manager UK and Ireland at DiaSorin Ltd

October 8, 2026 · Worked with Raf on the same team

When Raf and I worked together at DiaSorin UK, I was Business Development Manager and, in many ways, his mentor. It was a pleasure to watch him grow quickly into a confident and very effective product specialist and manager.

We worked closely on building our stool testing business, particularly calprotectin and faecal elastase. Raf coordinated the validations at our key opinion leader sites, and the quality of that evidence, together with the trust he built with the clinicians and laboratory scientists involved, made our conversations with customers far easier.

During the pandemic he played a central role in introducing our COVID-19 antibody assay to the UK market, including the Public Health England evaluation, under enormous time pressure. He stayed calm, precise and always available.

I would recommend Raf to any diagnostics company that needs clinical evidence and market adoption to move forward together.

Daniele Cunha

Healthcare · Medical Devices · IVD · Business Development · Interim Head – Erba Brazil

October 13, 2026 · Worked with Raf on the same team

I had the pleasure of working with Raf at Erba, and he’s one of those people you’re really glad to have on the other end of the line. He knows his stuff, he’s quick to respond, and when something needed solving he took care of it himself instead of passing it along.

What I appreciated most was how easy he was to work with across regions and time zones. With me in Latin America and the team spread all over, that mattered a lot. Raf was always clear, reliable and patient, and he made the collaboration feel like real teamwork.

Any team would be lucky to have him. I’d happily work with Raf again and recommend him without hesitation.

Rajendra Margam

Sr. Product Manager · Transasia Bio-Medicals Ltd.

October 8, 2026 · Worked with Raf on the same team

I worked closely with Raf during my time as Technical Services Manager and Senior Product Manager at Transasia, part of the Erba Mannheim group. He visited Mumbai several times to work directly with our teams on research and product development.

We collaborated on several projects, including LisaM, an all-in-one mini ELISA workstation, Lisa XL, an fully automated 6 plate ELISA processor and Lisa XY, a high-end ELISA reader. Raf worked with our R&D team on the specifications for the global market, and the products that resulted were of truly global standard, with performance that could stand against any international manufacturer.

Raf does not manage product development from a distance. He sat down with our technical and R&D teams, went through the performance data in detail, and explained clearly what laboratories in Europe and other markets required from the product, and why. This made our specifications sharper and our trade-off decisions far easier.

As an immunologist, he has a strong command of both assay chemistry and the analyser platform, which allowed him to hold substantive technical discussions while keeping commercial goals and regulatory requirements firmly in view.

For any company developing diagnostic products for international markets, Raf is a valuable bridge between R&D and the market.

Start a conversation

Book a 15-minute discovery call

A short video call to see whether we are the right partner for your product and company.

  • What to have readyThe product, its regulatory status and the markets you have in mind.
  • What you getA straight answer on whether we can help, and what a first project would look like.
  • Working internationallyCalls can be arranged across time zones.
15 minutes · video call

Request a call by email

Send two or three times that suit you, with your time zone, and Raf will confirm one with a video-call link.

Based in Poland, working with manufacturers and partners worldwide.