SolarisRTC
Company Mission Statement
SolarisRTC LLC is a digital health advisory company specialized in digital pathology and supports activities in the entire product development life cycle using translational medicine to expedite early market access to improve personal healthcare.
Company Vision and Philosophy
Our Vision:
SolarisRTC LLC, based in Silver Spring, Maryland, is a global company that helps to optimize the use of digital health in precision medicine, particularly in the field of digital pathology. Our vision is to make innovation and emerging products accessible to all patients across the globe
This is realized through providing our expert knowledge addressing specific needs and problems.
Our Values:
Trust:
We will work together to accomplish our goals and overcome challenges and solve problems.
Respect:
Respect everyone, treat each other with dignity, and be your own example.
Loyalty:
Value all contributors, challenge each other and collaborate to fiercely execute accomplishing our mission.
Innovation:
Challenge the status quo and be creative to overcome challenges to prosper and succeed.
Quality:
Quality over quantity.
Our Story
The company was founded in March 2023 by Esther Abels and is based in Silver Spring, MD, USA. Esther believes in challenging the status quo to accelerate bringing innovative, emerging products to patients, globally. She showed this by spearheading that Whole Slide Imaging devices were granted a de novo in USA, as well as getting the first digital pathology algorithms certified under IVDR in Europe. She believes she can do this by sharing her knowledge, expertise, experience gained over the last 25 years when working in pharma and biotech industry collaborating with biopharma, health care providers, government and payers since 1998. She transfers her skill set consisting of Clinical, Regulatory, Pharma, IVDs and Quality, as well as her reputation and network into being an architect. An architect who is laying the foundation to create synergy and expand brainpower to serve the common good.
This inspired Esther to come up with the name SolarisRTC, which stands for:
- Solaris: the universe, equality, all inclusive
- RTC: Research Trials Clinic: applying our skill set and knowledge in the total product lifecycle, being all inclusive with data equity globally.
- Circle of the logo: represents the total product lifecycle, as well as being all inclusive, providing global access to care for every human in the universe, using equality data from Research, Trials and Clinic to optimize processes, tools and devices to provide better diagnosis, right therapy and optimize care.
- The color of the logo: a warm color representing well being, a smile on the face of each human being in the universe.
Esther Abels
CEO and Founder SolarisRTC LLC
Precision Medicine | Biomedical Regulatory Health Science Expert
After having been a management team and C suite member responsible for contribution to the overall business strategy and leading pharma services Esther Abels started her own advisory company SolarisRTC in 2023. Esther has a background in business strategy, commercialization, bridging R&D, proof of concept, socio / health economics and pivotal clinical validation studies used for registration purposes in different geographies, for both pharma and biotech products. She has over 25 years of regulatory, clinical and quality experience specializing in bringing products to clinical utility. She played a crucial role in getting a De Novo for Whole Slide Imaging devices, i.e., reclassified these devices from the highest risk class III to a moderate risk class II device in USA and getting the first digital pathology algorithms certified under IVDR in Europe.
Esther drives efforts for reimbursement in digital pathology and collaborations with different Pathology Associations. She was the president for the Digital Pathology Association (DPA) in 2022, chaired the DPA Regulatory and Standards Taskforce and facilitates FDA collaborations to drive regulatory and standard clarifications for interoperability and computational pathology in the field of digital pathology. Currently she is the chair of the DPA Pharma Taskforce to find general principles around implementing digital pathology to discover and develop new drugs, biomarkers and other tools to accelerate the development pipeline.
She is also a co-founder of the Alliance for Digital Pathology, now named Pathology Innovation Collaborative Community where she was co-leading the reimbursement workgroup.
Esther holds an MSc in Biomedical Health Science from Radboud University Nijmegen, The Netherlands.
Our SolarisRTC Expert Team
SolarisRTC is proud to work with Regulatory & Clinical Affairs specialists. Our specialists have an in-depth expertise in obtaining IVDR certification for Medical Device Software (MDSW) / Software as a Medical Device (SaMD) in the field of Digital Pathology, such as but not limited to:
- Authoring and executing Performance Evaluation Plans and reports,
- Authoring requirements and related test plans and reports,
- Developing intended use and labeling documents,
- Contributing to successful IVDR audits and
- Engineering of Digital Pathology algorithms.
Our Value Proposition
Customer Problem
Bringing emerging and innovative products from its conception to the clinic, that is to discover, develop, validate, implement and apply them, requires commitment and investment. It requires a holistic approach which is orchestrated by an architect. An architect with a unique skill set which combines business acumen with
regulations, quality, science, clinical need, clinical and economic utility, including reimbursements, as well as
With a deep understanding of FDA’s and Competent Authority’s thinking and concerns.
Building this skill set and / or getting access to this, demands considerable efforts and resources (both capabilities and $), plus it consumes valuable time bringing the resources together. Often this easily results in prolonged lead time, delays in time to market and has a serious negative impact on revenue and profits.
Customer Need
An architect who:
- builds trust with FDA/Competent Authority (CA),
- can challenge status quo,
- can understand and challenge FDA/CAs,
- navigates this path AND
- at the same time can link this to the business strategy, i.e., someone who recognizes risks and consequences to prevent these risks become issues.
- is creative to solve problems and find solutions.
- understands the business and the consumer, and can guide the business to success, having knowledge readily available saving months of research, to accelerate time to market.
We can create an analogy to an architect who can build an innovative, different and customized house every single time as she understands the network, building blocks, stakeholders and regulatory pathways to get there, while being and remaining compliant.
Gain For The Customer
We pride ourselves as a company who delivers and is transparent about related costs, timelines, and risks. SolarisRTC is strong in expediting, automating, seeking and supporting optimization of drug- and device development, for which we can advise on business model, pricing model, product, service, platform, data and management:
- Potential for shorten time to market,
- Identify quick wins, such as instead of letting a customer build a villa, letting them build a scalable product using a step based approach,
- Potential for higher revenue using value based care leveraging knowledge of clinical and economic utility, and
- Penetrating new markets and in parallel expanding products.
Differentiation From Competition
A unique combination of five (5) skills and expert knowledge in Regulatory, Clinical, Quality, Pharma and IVD.
Having a large network in Regulatory, Clinical, Quality, Pharma and IVD, as well as HEMA
(Health Economics Market Access including reimbursement for Return on Investment)
Benefits of Working with SolarisRTC LLC
SolarisRTC supports activities in the entire product life cycle using translational medicine to expedite early market access to improve personal healthcare.
This is realized through providing our expert knowledge addressing specific needs and problems by offering our unique capabilities:
- Providing expert knowledge in regulatory, clinical, quality, commercialization and business strategy, gained since 1998 when working in pharma and biotech industry collaborating with biopharma, health care providers, government and payers, to address specific needs and problems.
- Transferring skill set of Clinical, Regulatory, Quality, Pharma and IVDs to optimize collaborations with our and your network.
- Being an architect laying the foundation which enables creating synergy and, expands brainpower to serve the common good.
- Challenging the status quo to accelerate bringing innovative, emerging products to patients, globally.
Through collaborations we build a strong foundation to connect all crucial elements in digital health to deliver precision medicine to patients.
Digital health, including digital pathology creates a new way to interact, and that will benefit everybody. Bringing innovation and emerging products, and specifically companion diagnostics to patients, can be considered a “maze” with many stakeholders, all with different thinking and goals, involved. The solution is, instead of the typical linear approach, to have a vision, a holistic view and systemic approach to work as a collective with a cohesive value story.
The various assets and stakeholders have to be aligned to optimize the value proposition of the innovation early in time. Typically industry, health care providers, government, don’t have this unique combination of skillsets being at the center of that.
An architect with a strategic holistic view, including regulatory science1 is the solution. SolarisRTC provides this through its unique features combining its capabilities, ensuring innovation can be implemented by identification of how all is interwoven in standard of care.
1, according definitions of the FDA “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science .“
SolarisRTC has the relevant network, understands the stakeholders and has the required knowledge, i.e., Regulatory, Clinical, Quality in both In Vitro Diagnostic Devices and Pharma, and can deliver the global strategy for the business, including product architecture in line with regulations and reimbursement optimization, and strategic partnerships. A sample of work packages where we provide our support:
- Research
- Clinical affairs, validation and utility
- Regulatory affairs
- Technologies / Platforms
- Reimbursement
- Commercialization
- Marketing
- Due diligence
- Business models.
SolarisRTC is strong in expediting, automating, optimizing drug- and device development, for which we can advice on platform, data and management.
SolarisRTC makes a difference immediately by providingsupport to increase footprint through applying expert knowledge in commercialization and business models.
SolarisRTC can help you bring new and / or emerging products to patients faster
For Whom Are We Creating Value
Biotech in digital pathology to bring regulated products to market.
Pharma to discover, develop and commercialize using digital pathology.
Clinical Research Organizations interested in using digital pathology tools to optimize clinical study execution workflow to be or become the preferred partner for pharma.
Laboratories to enhance laboratory medicine to bring their products to market, faster.
Venture Capitalists to gain more insights and better predict their return on investment.
Take the First Step
We want to hear about your unique business needs.
Schedule time to learn how SolarisRTC can support you in achieving your mission and successes. We are excited to partner with companies growing their revenue, accelerating their product pipeline and expediting early market access to improve personal healthcare.
