From clinical and real-world evidence programmes to technology assessment, portfolio strategy and organisational transformation, our work helps healthcare leaders turn uncertainty into informed decisions and implementable action.
International evidence programmes connecting consistent study design with local clinical practice, investigator networks and market context, turning diverse real-world experience into comparable evidence for clinical, medical and commercial decisions.
Post-market evidence programmes identifying evidence gaps and translating clinical use into structured data for regulatory documentation, clinical evaluation, risk management and product-lifecycle decisions.
Medical aesthetics · Seven countries · Two evidence programmes
A premium, innovation-led medical-aesthetics manufacturer needed evidence for two different starting points: launching a hyaluronic-acid dermal-filler portfolio in a saturated European market, and strengthening longer-term post-market evidence for a collagen-stimulating injectable used to improve skin laxity and quality.
The decisions concerned priority indications, credible differentiation, investigator advocacy, safety and effectiveness evidence, and the claims and publications the data could responsibly support.
theSKINBOX designed and coordinated two complementary programmes. The filler study covered seven countries, 23 dermatologists and plastic surgeons, 153 patients, 246 procedures and 385 treated facial regions, with assessments at injection, one week and four weeks.
The longer-term programme followed 73 patients treated by six experienced aesthetic physicians across five countries, five anatomical areas and seven visits over 25 months. We developed protocols, investigator guidance, questionnaires, validated indication-specific scales, standardised photography, consent and anonymisation processes, data-quality controls and reporting. External statistical expertise was integrated into questionnaire design, analysis planning and consolidated interpretation.
Fragmented clinical experience became comparable European evidence.
The filler programme quantified treatment patterns, handling, performance, adverse events, satisfaction, competitive perception and intention to use, revealing strong acceptance alongside an important need for expectation management at later follow-up.
The collagen-stimulator programme produced interim safety evidence across all five treatment areas. Outputs supported PMCF and PMS documentation, launch strategy, claim refinement, KOL development, professional education, sales training and white-paper or publication development.
Medical devices · Five UK sites · Class IIa MDR transition
An established professional phototherapy brand needed to determine how a Class IIa, multi-wavelength LED system could build indication-specific evidence for MDR transition.
The challenge was broader than demonstrating device performance: evidence had to cover acne, psoriasis, inflammatory skin conditions and skin rejuvenation, work in routine UK clinics, and withstand clinical-evaluation and Notified Body scrutiny.
theSKINBOX designed and operationalised a prospective, open, multicentre programme across five UK sites, with 10 to 15 patients per site and a target of ten completed cases per indication. Dermatologists assessed the medical indications, while appropriately qualified nurses, aestheticians and skin therapists contributed to non-medical indications.
Eight treatment sessions over four weeks were linked to investigator and patient assessments, electronic case-report forms and standardised photography. Endpoints included indication-specific clinical scales, patient self-assessment, adverse events, satisfaction and dermatology quality of life.
We implemented consent, eligibility criteria, treatment protocols, digital collection, patient-unique-code anonymisation and data-quality requirements. External regulatory and medical-writing specialists were integrated for gap mapping, Clinical Evaluation Plan and Report revisions, and indication-level claim review.
A broad legacy indication set became a structured evidence pathway linking clinical practice to regulatory decisions. The programme created consistent, auditable data capture across heterogeneous clinics and clarified which endpoints could support each indication.
It also established the bridge from post-market evidence to PMCF and CER updates, Notified Body responses, defensible marketing claims and future reports or publications, without treating planned outputs as completed clinical results.
Executive advisory and interim leadership across R&D, Regulatory, Medical, Product Development and commercial priorities.
Across four global mandates between 2021 and 2026, theSKINBOX supported established healthcare, MedTech, skin-care and advanced-materials businesses at critical points of innovation and portfolio transformation. The work ranged from research and strategic evaluation to evidence planning, organisational redesign and operational implementation, including the leadership of international R&D organisations of up to 50 people across three manufacturing sites.
Across all four mandates, theSKINBOX provided the link between intelligence and execution: researching the opportunity, evaluating what deserved investment, designing the scientific and organisational pathway, and leading the transformation required to move it forward.
Global dermocosmetics company · Global mandate, 2021–2025
Which innovation opportunities were scientifically credible, commercially relevant and sufficiently differentiated to justify further investment? What evidence and claims would be required to move selected concepts towards development and market activation?
theSKINBOX worked across R&D, Medical Affairs and Marketing to generate, assess and pre-select innovation opportunities. We translated selected ideas into product and scientific concepts, defined their scientific rationale and claims architecture, and designed the associated clinical, in-vitro and ex-vivo evidence plans. The mandate also included KOL engagement, publication planning and scientific visibility.
A broad innovation space became a more focused, evidence-led development pipeline. Selected concepts moved forward with clearer differentiation, defined claims and decision-ready evidence pathways, allowing scientific, regulatory and commercial considerations to be addressed earlier in development.
International ophthalmic MedTech · Interim global mandate, 2021–2023
How should the company prepare the first major relaunch of an established refractive-laser platform in more than a decade?
The upgraded technology required more than a conventional product launch. The company needed to determine how the relaunch should be prioritised across regions, how adoption could be secured among existing customers and expanded to new users, and how a significant price increase could be communicated through a credible clinical and commercial value proposition.
This required international market and customer intelligence, differentiated B2B and B2B2C positioning, and closer coordination between an isolated headquarters function and regional and national teams.
With no Strategic Marketing Director in place, theSKINBOX assumed interim leadership of the internal strategic marketing team. We provided structure and direction to the function while developing the strategic foundations for the relaunch.
In parallel, we developed the team structure and working model required to support the relaunch and prepared the function for transition to a newly appointed permanent director.
A temporary leadership gap was stabilised, and the strategic marketing team gained clearer priorities, responsibilities and ways of working.
The relaunch evolved from a predominantly headquarters-led product initiative into a more internationally informed and regionally connected programme. Regional perspectives became part of launch planning, customer adoption was addressed as a strategic challenge, and the price increase was supported by a more coherent clinical and commercial value narrative.
B2B, B2B2C, scientific and KOL activities were brought into a common launch architecture. When the permanent director joined, the company had a more structured strategic marketing function, an advanced relaunch programme and a clearer platform from which to continue global execution.
Family-owned dermatological skin-care manufacturer · Interim global R&D mandate, 2024–2025
How could a newly acquired manufacturing site be integrated into the company's R&D and quality organisation without compromising product quality or operational continuity? How should an underperforming R&D function be rebuilt when responsibilities, specialist expertise and effective collaboration were missing?
At the same time, what regulatory capabilities would the company need to support its planned expansion into Asian markets, particularly China?
As Interim Global Director R&D, theSKINBOX led a 35-person organisation spanning Regulatory Affairs, Product Development and Packaging, Microbiology and Quality Systems.
The mandate combined post-acquisition integration with organisational and operational transformation. We integrated the acquired site and its previously separate quality function into the wider organisation, oversaw quality during the transition and assessed structural, capability and leadership gaps across the R&D function.
We also redesigned the leadership structure and supported the recruitment of key Quality Systems and Regulatory Affairs positions, alongside the appointment of a new Head of Product Development. In parallel, Regulatory Affairs was strengthened as a strategic capability, with future registration and market-access requirements for Asia connected more closely to product development, quality and portfolio decisions.
A fragmented post-acquisition setup was transformed into a more integrated R&D and quality organisation, with clearer accountability, stronger functional leadership and closer integration between Product Development, Regulatory Affairs, Quality Systems, Microbiology and laboratory operations.
The organisation became better equipped to address the structural causes behind quality and innovation weaknesses, and better prepared to support future international growth.
Global advanced-materials manufacturer · Global mandate, 2025–2026
Which parts of the existing technology portfolio offered the strongest potential for growth, margin improvement and differentiation? Where should the company improve current products, and where should it invest in new platforms for hygiene categories, including baby care, adult incontinence and feminine care, and for medical applications?
theSKINBOX combined strategic advisory with interim R&D leadership. We assessed markets, competitors and the existing portfolio, connected unmet customer and skin-health needs with technical and manufacturing capabilities, and identified priorities for product improvement and future offerings.
In parallel, we led a 50-person global R&D organisation across Regulatory Affairs, Product Development, Intellectual Property, pilot operations and laboratories at three manufacturing sites in Germany and Türkiye.
A predominantly technology-led portfolio was reframed around clearer market needs, business value and strategic time horizons. Near-term product opportunities and longer-term innovation platforms became more explicitly prioritised, while cross-site R&D governance was strengthened around commercial relevance, sustainability, regulatory requirements and defensible intellectual property.
Independent market and portfolio intelligence clarifying where to compete, what to prioritise and how products, channels, pricing, capabilities and business models must work together.
Skin-care start-up · Eczema-prone skin
Could an early-stage skin-care concept for eczema-prone skin become a credible, differentiated and commercially viable proposition? The founders needed to determine which audience to prioritise, how to position the offer and which channel and pricing model could support market entry.
theSKINBOX combined category and competitor intelligence with an independent evaluation of consumer needs, positioning opportunities and channel requirements. We assessed the relationship between product concept, credibility, target audience and commercial model, then developed recommendations for positioning, channel selection and pricing strategy.
The project moved from a broad product idea to a more focused, decision-ready proposition. The founders gained clearer parameters for whom the offer should serve, where it could compete and how its positioning, pricing and distribution needed to work together. This created a stronger basis for a go, redirect or pause decision before further investment in product development and launch.
Digital health and beauty retail · Skin of colour and diverse skin needs
How could a proposed online platform for specialised skin care become more than another product-led web shop? The client needed to define its target market, select a credible brand portfolio and determine which digital functions could help customers navigate the specific needs of skin of colour.
theSKINBOX researched the category, evaluated potential brands and developed criteria for a focused, relevant assortment. We advised on platform functionality, including skin-diagnostic and guided product-selection tools, and supported early negotiations with manufacturers. Our work connected consumer needs, portfolio strategy, digital experience and commercial feasibility.
The concept evolved from an assortment-led retail idea into a differentiated specialist platform with a clearer value proposition. Brand selection became more systematic, diagnostic functionality was linked to real customer decisions, and manufacturer discussions were supported by a more credible commercial concept. The result was a launch-ready platform blueprint rather than simply a list of products and technical features.
Consumer health · Non-prescription vitamin supplements
Should an international vitamin-supplement portfolio enter the German pharmacy channel, and if so, how could it establish relevance in a crowded and highly trust-dependent market? The client needed to clarify positioning, competitive advantage, channel fit and the role of professional advocates.
theSKINBOX assessed the German pharmacy landscape, competitor propositions and the expectations of pharmacists and consumers. We translated this intelligence into market-entry and positioning recommendations, identified potential advocates and tested key assumptions through interviews with pharmacist key opinion leaders.
The client gained a more realistic view of the opportunity, the barriers to entry and the differentiation required to compete. Positioning and channel priorities became sharper, while direct professional feedback exposed which messages were credible and which required refinement. This provided a stronger basis for the market-entry decision, partner engagement and the development of a pharmacy-specific launch model.
Professional education · Aesthetic practices and clinics
How could a physician network translate its expertise into a structured, scalable education offer that helped aesthetic practices make better business and investment decisions? The programme needed to move beyond individual training sessions and address the interconnected realities of building and operating a successful clinic.
theSKINBOX designed a complete ten-module business curriculum and developed the accompanying video content for online delivery. The programme integrated practice positioning, service and treatment portfolio design, patient recruitment, team development, and the evaluation and selection of technologies and services.
A broad field of expertise became a coherent, repeatable educational product. The network gained a launch-ready online programme with a clear structure, consistent content and direct relevance to clinical business decisions. For participating practices, technology and service choices were placed within a wider operating model, connecting investment decisions with positioning, patient demand, team capability and sustainable growth.