Research and Market Development
- Clinical picture
- Market analysis
- Product development / final design
- Cost of goods vs. market pricing
Nice to meet you!
Our mission
To get proven medical devices and diagnostics into the hands of clinicians faster by giving manufacturers one experienced partner, from first concept to first revenue.
Who we are, and what we do
101 Communications is a one-stop shop for diagnostics companies taking a product to market. Our team brings more than 100 years of combined experience in commercial leadership, clinical development and marketing, gained in blue-chip companies and refined in start-ups around the world. We are European-based and work across Europe, the Middle East, Africa and Asia, tailoring our support to where you are in your product’s life cycle.
Strategy and launch planning
From concept and pre-registration market analysis to a launch plan built around your budget and designed for maximum impact. We know from experience what works, what doesn’t and how to reach your first revenue sooner.
Clinical evidence
Our clinical team and network generate evidence that meets the requirements of journals, regulators and payers without breaking the bank or taking years.
Regulatory and quality
Partners who know the latest IVDR, FDA and MHRA requirements and can audit your quality system to make sure it is fit for purpose.
Technical and operational
Specialists who can reduce your cost of goods and make your scale-up robust.
Marketing and communications
Brand, positioning and launch campaigns for international audiences, from scientific materials and key opinion leader programmes to congress presence and digital.
Route to market
A complete package covering logistics, cold-chain storage and a network of specialist distributors, managed on your behalf so your product gets the focus it deserves.
Services
Pre-Launch
- Regulatory data
- Pre-launch clinical studies
- Brand development
- Distribution strategy
- KOL relationship development
Launch
- Point-of-sale literature
- Website
- Product videos
- Congress planning
- Regulatory filing
Post Launch
- Post-market surveillance
- KOL roundtables
- Concordance papers
- Post-market studies
- Distributor management
Our Approach
Assess
IVDR / MDR classification, a gap analysis of your technical file and clinical data, and a market and reimbursement review for target countries.
Launch
Notified body route, EU authorised representative, import and cold-chain logistics, post-market surveillance, key opinion leader engagement and first reference sites.
Scale
Direct rollout, a single major distribution partner or specialist distributors, whichever best fits the product. Supported by publications and ongoing clinical evidence.
Study, analyse, produce and roll out all marketing and sales tools specific to each stage.
Team
Commercial medtech executive with extensive experience in international market development, product launches and building high-performing multidisciplinary teams.
Commercial diagnostics leader with three decades of experience in IVD, specializing in European market development, distributor networks and successful product launches.
Life sciences executive with a master’s degree in biology and extensive international experience in molecular diagnostics, global product strategy and clinical market development.
Communications strategist and creative director focused on brand positioning, integrated campaigns and translating complex ideas into clear, effective narratives.
Some clients we’ve worked with
