SolarisRTC Insights
SolarisRTC Blog Posts
With this blog, we like to give insights into industry trends, regulatory and clinical science, commercialization and market access.
No more side effects
No more side effects A quick search with key words “side effect definition” resulted in a list with multiple definitions, of which I picked the three (3) references Google displayed at the top: NCI dictionary of cancer terms* “An effect of a drug or other type of treatment that is in addition to or beyond its desired effect. Side effects can be harmful or beneficial, and most go away on their own over time. Others may last past treatment or appear long after treatment has ended. Some common
One size does not fit all
One size does not fit all As many of you, I was participating in the annual American Society of Clinical Oncology (ASCO) event. It always impresses me the amount of individuals participating in this event and working in this space. I am grateful to be one of them, to be a cog in this continuum called health care, a part of the community dedicated and devoted to improve health care. I am grateful to collaborate and contribute to define a new path to better manage cancer which affects
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
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.
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
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
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
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
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
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
…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
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
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
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
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
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,
