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Therapeutic Areas Aesthetics & Dermatology

Aesthetics & Dermatology

The aesthetics market continues to expand rapidly as technologies evolve to enhance form, function, and confidence.

Success in this dynamic space requires more than clinical precision; it demands a partner who understands the nuances of aesthetic device development, regulatory expectations, and patient experience.

Avania brings a MedTech focus and decades of specialized expertise in the design, testing, and commercialization of aesthetic technologies. From injectables and implants to energy-based systems and reconstructive innovations, we provide the operational excellence, scientific insight, and global reach to bring your innovation to market safely and efficiently.

Connect with Our Aesthetics Experts
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Navigating the Unique Challenges of

Aesthetics Device Development

Aesthetic technologies are unlike any other category in MedTech. Every procedure carries variability in anatomy, technique, and outcome expectations, and every study demands meticulous control to demonstrate both safety and measurable aesthetic improvement.

Avania understands these complexities and tailors every engagement to the specific demands of the product and indication.

  • Regulatory Nuance: Deep familiarity with PMA and IDE requirements for aesthetic products, including HA fillers, implants, and combination devices
  • Procedural Variability: Study designs account for wide inter- and intra-site technique differences and operator skill
  • Imaging-Driven Outcomes: High-resolution imaging, calibration, and standardized acquisition workflows ensure consistent endpoint assessment
  • Healthy Populations: Long-term registries and proactive PMCF studies demonstrate sustained safety and durability in non-therapeutic populations
  • Non-Pharma Expertise: As a MedTech-focused CRO, Avania brings device-centric study design, execution, and analysis, unlike pharma-first organizations less attuned to procedural studies

Unparalleled Expertise:

Meet Our Aesthetics MedTech Veterans

dr benjamin caughlin

Principal Consultant, Aesthetics SME

Dr. Benjamin P. Caughlin, MD, FACS

  • Board-certified facial plastic and reconstructive surgeon, recognized among the nation’s top specialists
  • Dr. Caughlin advises on endpoint selection, procedural variability, and trial design for device-based and surgical aesthetics
amber salomons

Principal Medical Writer, Medical Writing

Amber Salomons, PhD

  • 14+ years in cosmetic and aesthetic research
  • ISO 14155- and GCP-certified
  • Experienced across pre-market and post-market aesthetic device studies in both the U.S. and EU
Technology background

The Avania Team Advantage

Avania’s aesthetic specialists are recognized leaders in device and procedural innovation, combining regulatory foresight, operational precision, and a collaborative mindset. Every client engagement provides direct access to senior leadership and subject matter experts, ensuring transparency, agility, and shared purpose.

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Deep Therapeutic & Industry Insight

Our team has supported the full range of aesthetic technologies — from dermatologic lasers and injectables to implantable scaffolds and reconstructive devices — bringing insight into study design, blinding feasibility, and endpoint selection. We partner with sponsors from feasibility through post-market, aligning regulatory, engineering, and clinical strategy every step of the way.

With extensive experience across FDA, EU MDR, and regional frameworks, we help clients anticipate reviewer expectations, avoid delays, and secure approval efficiently.

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Consistent, Dedicated & Flexible Teams

Low turnover, hands-on leadership, and proactive communication ensure true partnership and continuity. Our teams adapt to each client’s workflow and culture, functioning as an extension of your internal team.

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Integrated Solutions for Aesthetics Innovation

Avania’s end-to-end service model connects every stage of aesthetic device development — from feasibility and prototype evaluation through pivotal trials, approval, and post-market evidence generation — under one coordinated global team. This integrated structure minimizes handoffs, accelerates timelines, and preserves strategic continuity.

Strategic Consulting & Regulatory Pathways

Aesthetic innovations often combine modalities such as device-drug-biologic systems or novel mechanisms without predicate devices. Avania’s regulatory experts have guided numerous sponsors through De Novo, PMA, and combination-product submissions.

We provide early planning and pre-submission support to ensure strong alignment with evolving FDA and EU expectations, including evidence requirements for biocompatibility, human factors, sterility, software validation, and labeling.

Clinical Development & Execution

Our operational teams design and manage trials that account for aesthetic-specific challenges: short enrollment windows, outpatient sites, and subjective endpoints. We mentor and train less experienced site teams, promote enrollment efficiency, and maintain consistency across global programs.

  • Dedicated site mentorship during investigator meetings and SIVs
  • Strong vendor network for high-resolution imaging and analysis
  • Expertise in scale-based endpoint measurement and statistical validation
  • Experience with PMA, IDE, De Novo, and post-market follow-up programs
  • Agile project management to sustain engagement and accelerate timelines

Our Track Record

Demonstrated Success in Aesthetics

Avania’s aesthetics portfolio demonstrates both clinical and commercial success across reconstructive, cosmetic, and combination-product studies. We have supported more than 20 projects in oncology, medical device, and aesthetic applications, including pivotal U.S. and EU programs for breast reconstruction and soft-tissue reinforcement technologies.

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Cosmetic Procedure Experience

  • Facial contouring, dermal fillers, and wrinkle reduction
  • Breast prosthesis and augmentation
  • Breast reconstruction for soft tissue support and repair
  • Tummy tuck (abdominoplasty) and body contouring
  • Cellulite procedures for buttocks and thighs
  • Lip and chin augmentation
  • Nasolabial folds and facial volume correction
  • Hair restoration and skin rejuvenation
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Aesthetic Surgery Experience

  • Facial fillers and augmentation
  • Skin and soft tissue repair
  • Abdominoplasty
  • Breast augmentation and reconstruction
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Client

Successes

Avania’s leadership in reconstructive and cosmetic studies has been proven across multiple continents, with trial footprints spanning North America, Europe, and Asia–Pacific.

With more than 900 MedTech projects, 500+ regulatory submissions, and 25+ Breakthrough Device designations supported globally, Avania offers unmatched experience translating innovation into approved, market-ready solutions.

“Clinical research is booming in aesthetics, and the market demand is driving the need for fast, efficient trial execution. With Avania, we’re able to move quickly — their team is always prepared, responsive, and thorough. Whether I’m working with them as a site investigator or in a consulting capacity, they bring the same level of professionalism and agility. We’ve been able to enroll trials rapidly without compromising quality, thanks to their deep expertise and collaborative approach. Avania truly understands the pace and precision this field requires.”

Dr. Benjamin Caughlin, MD, FACS
Facial Plastic Surgery Expert

Case Study

Accelerated Market Path for Resilient HA Fillers

Product and Indication:

Resilient hyaluronic acid (HA) fillers

Solution:

Avania partnered with the sponsor on a comprehensive project plan and exceeded enrollment targets by 30%, allowing the filing of the regulatory submission ahead of timelines

Problem:

Get to market in an expedited manner

Outcome:

FDA submission went in ahead of schedule

Case Study

Leveraging Real-World Evidence to Drive Strategic Acquisition

Device:

FDA approved mesh scaffold used in plastic and reconstructive surgery

Solution:

Avania partnered on a retrospective, multi-center study collecting RWE across >1,600 procedures and follow-up visits

Problem:

Early adopter of FDA guidance on real-world evidence (RWE) use cases for label expansion

Outcome:

Sponsor leveraged RWE in sales process to large, strategic medical device manufacturer, which closed in a successful acquisition

Case Study

Navigating FDA Scrutiny to Establish a Novel Path to Market

Device:

Mesh for tissue reinforcement

Solution:

Avania partnered with the sponsor on study design and FDA strategy, resulting in an IDE approval and novel clinical, regulatory path to market which blends prospective non-randomized data as a comparison to retrospectively collected historic control

Problem:

Disease state (breast reconstruction post mastectomy) under heavy scrutiny at FDA following a long history of device failures and public panel meetings challenging the state of care

Outcome:

Avania and sponsor operating within robust study project plan and timelines, managing the dynamic study within budget and target timelines

Partner with Avania’s

Aesthetics Experts Today

Aesthetic innovation blends artistry and science. With Avania, you gain a global MedTech partner who understands both, offering the regulatory clarity, clinical precision, and operational strength to bring your vision to life.

Connect with Our Aesthetics Experts