SolarisRTC Insights

SolarisRTC Blog Posts

With this blog, we like to give insights into industry trends, regulatory and clinical science, commercialization and market access.

Science talks. Collaborative partnerships make it happen.

Science talks. Collaborative partnerships make it happen. The LDT rule. It is here, it has been announced. There are many comments, blogs, websites, articles, webinars, panel sessions and posts published about it and it affects many. Therefore, I am grateful to notice that all affected stakeholders, have been, are and keep partnering in development of AI tools, independently whether it is an LDT or IVD. Two weeks ago I participated in an Medical Imaging and Data Resource Center (MIDRC) workshop taking place at the National Institute of Health

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Look backward to move forward

This can’t be it, there has to be more than this!

Today Mar 24, 2024 a year ago I founded SolarisRTC LLC with the mindset to serve and help patients. Being in the healthcare industry for over 25 years, I identified many mistakes, many impediments which all create opportunities to improve. Over the years, I noticed and realized more and more that industry is for its rightfully so and understandable reasons led by their capital investors and as result might divert from its original aspiration.

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Combining medical with business

Why this blog today? To emphasize what lab medicine needs, i.e., a holistic approach from a holistic viewpoint to solve the current problems we are facing. Using technology, with a business mindset to help patients.  The other week I was honored to present my use case, a holistic approach from a holistic viewpoint “AI tools in healthcare, a path to implementation” at the seminar “Innovation in medical technology and entrepreneurship cross Harvard”. Not only did I enjoy and felt grateful to be amongst entrepreneurs like myself, I felt driving energy vibrating

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A road with 2024 displayed

Hello 2024!

May 2024 be wonderful!  Wow, 2023 has been quite a year personally and professionally. Just like most of us, I use this last week of 2023 to reflect, personally and professionally. This year professionally includes my own business, focusing on precision medicine, digital pathology and regulatory science. Having our SolarisRTC team grown and evolve, we are daily collaborating on regulatory documents, bookkeeping, clinical study designs, test designs, regulatory science, webdesign, strategizing, coaching, mentoring and much more. Collaborating with partners and clients to optimize the product life cycle, services

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Sunshine rays that are red and pink over a batch of water

Tell me, why again?

Why do we do what we do? Last week I attended the Personalized Medicine Coalition (PMC) conference. I ENJOYED it. The line up of presenters, panels and contents was perfect. Discussions about politics, investments, return on investment, latest device and treatment developments and their trends, and its influence on current and future healthcare AND how this affects THE PATIENT. Patients, who regarded themselves in remission or survivors, shared their own personal stories and experiences. Absolutely inspiring! If you need inspiration, go read about Bonnie Addario what a beautiful

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A ball on a beach at sunset.

We Build A Strong Foundation

When you say Orlando, you think Disney, Universal…I think Pathology Visions! Last week it was Halloween weekend, and it didn’t go unnoticed at the Pathology Visions conference…walking to the conference, we had to pass a spooky event. Many spooky costumes, masks, puppets,…People invested a lot of efforts in dressing up and it was impressive to observe. But more impressive was Pathology Visions. As always, it was well organized by the Digital Pathology Association (DPA) and there were ~800 attendees. The atmosphere was “SHARING”. Knowledge sharing, innovation sharing, experience

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Two females looking in the same direction

Proposed LDT Rule and Patient Considerations

The LDT rule. I am going to keep this blog brief, because there are many posts on several media already, all with many thoughts and considerations. What I blog about today, is looking at it from patient perspective. As FDA points out in their proposed rule (PR), “an LDT to be an IVD that is intended for clinical use and that is designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)… “ and “at the time of

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digital pathology microscope, computer keyboard, data blocks, medicine capsules.

Digital Pathology is here to stay

Before start reading my blog, answer this question please:What drives patient management? Before providing my response to this question, let me start with sharing my statement, then with explaining the reasons behind my statement, providing my perspective response to the question and conclude with next steps. Statement:Digital pathology (DP) is here to stay.I am stating this, as I believe in digital health and digital pathology. Here is why:When attending conferences, reading and researching articles, having interpersonal, interconnected, engaging and insightful conversations with you, I have been observing that

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The word Interoperability on top of a white puzzle pieces.

…High on the agenda? Difficult? Important? Necessary? 

… High on the agenda? Difficult? Important? Necessary? These are some examples of the unpublished words of the question “Why is interoperability so…?” of my previous blog. The answer to all these? Because it brings value to whom needs it! Yes, unfortunately it is also the answer to the question why interoperability is so difficult. As industry, as government, as health care provider, as human being, we all want the best for our people, we all want to bring value to whom needs it. We also want to

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Medical person holding a tablet with a light shining up with a ring of icons

Why is interoperability so…?

Since I started in digital pathology in 2011, I noticed that interoperability has been on the agenda. It has always been prioritized because it is a high need to advance health care. And yet, here we are: still on the agenda, still being prioritized. Are we making progress? Today I would like to address interoperability in digital pathology.About the needs of interoperability and to serve the people who we are supposed to serve, to truly bring precision medicine to the ones in need. First, I address the definition

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Doctor holding icons that present a value based healthcare model

From Volume Based to Value Based Care

From volume based to value based care. This is what we hear. This is what we wish for our patients, this is what we want for our loved ones, for ourselves. Why then is it not happening? Today I am going to blog about reimbursement of diagnostic tests in the USA. I believe reimbursement can accelerate adoption of precision medicine.First I am going to discuss what is out there, then how we can get there.Molecular, Digital utilization is making personal healthcare possible, bringing benefits to patients.Personal healthcare is

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Laboratory Research with data graphics

FDA Pilot Program Lab Developed Companion Diagnostics

Today the FDA published a pilot program using minimal performance criteria for companion diagnostics. When reading it, I regard this could benefit patients and labs. FDA seems to be looking into no more one-drug-one test using minimal performance criteria. I certainly applaud this; it’s about care and well-being of patients. Reading the guidance, it seems that any test that meets these criteria could be used as CDx, rather than having to use only one specific test. This is coming ca. 2 years after the publication of FDA’s group

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A title that reads What Are You Waiting? with a clock on the right.

Grow Strong Through Teamship

ASCO, what a great conference (https://conferences.asco.org/am/attend). I am grateful to be among so many people working to fight against cancer. Can you imagine, what it would be like, when the collaboration in the pre-competitive space would grow stronger? I can. With this blog I want to take the opportunity to share that it’s no longer one size fits all in patient management, but it is one size fits all methodology how to enable precision medicine. I am convinced that when we identify one size fits all methodology, we

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Believe written on a beach at sunset.

When Following Your Inspiration Anything Is Possible

With my first blog on my own company’s website, I am sharing why I believe when following your aspiration anything is possible! These words sound too good to be true and usually when you read something that is too good to be true, it’s not. This is true. With today’s blog I am sharing my aspiration. I believe when we focus on what is strongly present in ourselves and focus on it, we can accomplish anything. Wow, that’s a big statement and I hear you saying and thinking,

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