From the Clinic to Diagnostics

Why I Made the Leap

When I stepped away from clinical practice, it wasn't because I had burnt out, or that I stopped caring about patients. If anything, it was the opposite. As physicians, our impact is oftentimes one-to-one -- the patient right in front of you at that point in time. There wasn't a way to meaningfully scale this as a working clinician, the impact had to be through working in industry.

Because of this, I made the intentional leap of faith to try two years in industry in the United States. After packing my bags in Sydney, Australia in 2017 and making the move to California, I told myself that if things didn't work out, I'd simply return back to clinical practice, knowing that I'd given it a shot.

Luckily, I landed a role as a Product Consultant at a CLIA lab in Southern California. I then graduated into commercial roles at the same firm. The rest is history.

The Shock of Leaving a Linear Path

Medicine offers one of the most structured career progressions in the modern workforce. You study, you train, you qualify, and you advance. Competence is measured in clearly defined milestones: exams passed, procedures mastered, years completed. There is a shared understanding of what excellence looks like, and you are graded against this established criterion.

The private sector, by contrast, is neither linear nor standardized. It's driven by variables that are rarely taught in medical school -narrative clarity, capital efficiency, negotiation, timing, and network effect. Success often depends less on technical brilliance and more on alignment, whether that be of incentives, stakeholders, or momentum.

That transition can be disorienting for physicians and goes completely outside of the mental model we have been trained on. Clinical authority is built on expertise and experience. In business, authority must be earned through persuasion, execution, and vibes (yes -- this is a thing). The metrics are fuzzier, the feedback loops are slower, and the rules are more fluid.

For example, physicians oftentimes treat networking as a soft skill. In industry, networking is infrastructure. Many physicians underestimate how central it is to success. Your first non-clinical opportunity is unlikely to come from a job board. If it is, chances are you're one of a hundred applicants. Instead, it will come from someone who understands how you think, trusts your judgment, and is willing to introduce you into a room you have (unfortunately) not yet earned entry into. It will be both a demoralizing and extremely humbling experience.

What I Learned About Commercializing Healthcare

After leaving clinical medicine, I spent several years in diagnostics and business development before spinning up my own company. That experience reshaped how I understand healthcare innovation.

In clinical environments, physicians are trained to believe that strong evidence wins. In reality, evidence is only one part of a much larger pie. A healthcare product must fit into workflow. It must fit into reimbursement logic, respect capacity constraints, and align with external forces such as new guidelines, new therapies, and shifting payer priorities. Furthermore, regulatory clearance doesn't always equal adoption. Just because the FDA approves doesn't guarantee a product will be adopted. Good science is necessary, but rarely is it sufficient.

Physician-operators - and especially physician-founders - often underestimate this complexity. I've heard horror stories from colleagues of ideas stalling because they were optimized for the clinic, but failed to fit within the bigger system. Science was there, but reimbursement was opaque. The product had amazing outcomes, but the COGS meant the gold standard remained.

Medicine teaches us to think clinically. Business requires us to think structurally.

What I'm Building and Why Now

Today, I am building Calaris Diagnostics as Founder/CEO. Calaris is a university spinout with a mandate to globally commercialize a portfolio of novel, patented saliva diagnostic technologies. Our lead asset is the first POC saliva-based screening tool for liver fibrosis secondary to MASLD. The scale of the problem is staggering. MASLD affects roughly one in three adults globally, and it's believed that 70-80% of cases are still undiagnosed. The progressive form, MASH, is now a leading indication for liver transplants.

Importantly, we are entering a new therapeutic era. Since 2024, a new category of disease-modifying liver therapies has altered the calculus. Screening high-risk populations is no longer an academic exercise, it has become economically and clinically rational. Health systems and payers are beginning to recognize that identifying clinically significant fibrosis earlier is both cost-effective and outcome-altering.

What has been missing is a tool that fits where patients receive care. Current screening approaches are largely blood-based composite scores (FIB-4) with imperfect performance. Imaging (TE), while useful, is resource-intensive and expensive to set up as a screening paradigm. A non-invasive, rapid, front-line screening tool embedded in point-of-care settings (PCP, community health, pharmacies) changes who gets appropriately referred to expensive diagnostics and advanced care.

When I describe what I'm building, I often say it sits at the intersection of three forces: a massive unmet need, imperfect existing tools, and a moment in time when new therapies make earlier detection meaningful. That alignment does not happen often and that is the reason I went all-in on Calaris.

Advice for Physicians Considering the Leap

If you are contemplating a move into biotech strategy, diagnostics, or business development, begin by reframing what your training has given you. Physicians possess translatable soft skills - pattern recognition, risk assessment discipline, and the ability to synthesize incomplete information under pressure. We've also been trained to be extremely resourceful.

Use these soft skills to learn the necessary business competencies. Examples include learning to read a cap table, understanding reimbursement pathways, and study how economic realities have shaped the system we see today. For the latter, it's important to not ask Does this work? but instead Who pays for this, and why?. After all, healthcare is a game of shuffling infinite needs in a resource-finite world.

Underpinning all this, be comfortable being early in something again. Transitioning from clinical practice into industry can feel like returning to residency (minus the structure) and can be extremely discomforting. Just know that this is a shared experience among all those that transitioned out.

Some concrete advice that's worked for me (caveat: this leans more towards physicians wanting to enter the early-stage/mid-market world):

  • Be willing to try an entry-level role but explicitly negotiate an accelerated progression

  • Offer to temporarily support a project for free to demonstrate ability and competence

  • Don't be afraid to take a temporary pay cut. I know that many of us have responsibilities like student loans, mortgages, families, but sometimes the offer must be so good that the employer can't refuse (I took a ~40% pay cut to land my first Product Consulting role. My offer: you can't find someone with my skills at this price point). This was my way in.

  • Network with the idea of bringing value first. The adage give and you shall receive is extremely true in industry

What Comes Next for Calaris

Over the next 12-24 months, the focus is disciplined and sequential: complete technology transfer, deliver a validated prototype, and engage the FDA through a formal pre-submission process with the hopes of Breakthrough Device Designation. Each milestone is designed not just to advance the science, but to meaningfully de-risk the company.

We are currently in the midst of that build phase - assembling the right technical partners, refining our development plan, and raising the capital required to carry the program through its next inflection point. For early-stage medtech companies, progress is completely milestone-driven, as revenue is gated by regulatory approval. The goal of this phase is to convert academic validation into product validation. Into a product that health systems, payers, and strategic partners can underwrite with confidence.

Beyond liver fibrosis lies a broader platform opportunity with our secondary assets, but we are deliberate in delaying that for when the time is right.

My Message to you all

As a physician who's successfully made that leap, I'm empathetic to those who are trying to do the same. It goes against the grain and requires substantial internal fortitude to push through. Because of this, my inbox is always open to those who want to hear my thoughts, get advice, or simply soundboard. I look forward to having these conversations because it's a reminder of how lucky I am, and I hope others can join me on this side too.

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Jim Chen, MD

About Jim Chen, MD

Jim Chen, MD, MPH is a physician-operator turned diagnostics entrepreneur. He is Founder & CEO of Calaris Diagnostics. Trained in Australia, he transitioned into US healthcare commercialization and previously served as Chief Business Development Officer at IHDLab, where he helped scale revenue 8x and launch Diagnostics-as-a-Service (DaaS) partnerships. He now focuses on building non-invasive screening tools that move high-value diagnostics into primary care and community settings.

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