Considering legal and regulatory aspects early in product development is crucial for streamlining time-to-market and enhancing business strategy. Legal issues can become obstacles during due diligence or serve as valuable assets for investors. Proper planning avoids delays, facilitates a robust business model, and aligns with long-term goals. 

Why Regulation is Critical for Business Strategy: In digital health, the line between regulated medical devices (e.g., “software as medical device”) and non-regulated software can be thin. Regulatory status influences the business model, time-to-market, and sales strategies. Adhering to regulatory requirements during development prevents costly last-minute changes and accelerates market readiness. 

When to Consider Regulatory Requirements: Regulatory assessments should begin during the initial stages of product planning and development. A detailed understanding of your product’s features, intended use, and indications ensures the viability of the business model and mitigates future hurdles. 

Highly Regulated Environment: The U.S. healthcare sector is extensively regulated, with federal and state laws governing healthcare provision, institutions, professions, and medical data. Tailored regulatory evaluations are essential for compliance and should account for product-specific requirements. 

What to Check 

• Privacy Protection: Privacy compliance is mandatory, especially in healthcare. In the U.S., HIPAA compliance is essential for products involving “covered entities” (e.g., hospital, physicians, clinics) or “business associates” (e.g., a supplier to a covered entity). For business-to-client models, and when HIPAA does not apply, federal and state privacy laws can be relevant. This legislation varies by state, necessitating a thorough review. DNA & biometric data may trigger  specific legislation as they usually attract regulatory attention.  

• Regulatory Authorization: Determining whether your product qualifies as a medical device can impact timelines and costs. Regulatory frameworks for “software as medical device” are evolving, with significant FDA guidance on mobile medical apps, clinical decision-support tools, and AI-enabled devices. Regulatory compliance spans the product’s lifecycle, covering quality control, design, risk management, and labeling. 

• Artificial Intelligence: AI regulation is rapidly developing. While no federal AI law exists in the U.S., hospitals (and other medical institutions) are required by federal law to implement measures aimed at mitigating bias in clinical decision-making tools, and the FDA has issued draft guidance on AI in medical devices and clinical trials. In addition, several states have enacted AI specific state laws that might be relevant. In this period of regulatory uncertainty, adopting AI risk management plans is strongly encouraged to align with emerging standards and best practices, mitigate exposure, meet the expectations of major companies, and attract investor interest. 

• Apps, Websites, and Patient Interfaces: Legal aspects such as terms of use, privacy policies, and informed consent must comply with privacy laws, consumer protection laws, advertising regulations, and disability legislation. Special care is needed for claims about medical benefits and products targeting healthcare professionals. 

• Reimbursement/Insurance: U.S. insurance coverage, known as reimbursement, affects pricing, sales potential, and clinical data requirements. Regulatory approval alone does not guarantee reimbursement, making reimbursement/Insurance expert consultation vital for market entry. 

Additional Considerations: Regulatory choices influence tax planning and Intellectual Property (IP) strategies. For instance, claiming regulatory similarity to existing devices for approval may expose your product to IP challenges. Strategic alignment with regulatory requirements can assist with smoother market integration and long-term success. 

This newsletter is provided for educational purposes only and does not constitute legal advice or legal opinion. Do not act on the information presented without appropriate professional advice after a comprehensive and thorough examination of the specific situation. 

An “orphan designation” is granted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a drug/biologic to create financial incentives for developing therapies for rare diseases.  

This article focuses on the FDA orphan designation program in respect to the incentives offered, the prevalence that defines an orphan disease, as well as the procedural process of obtaining the designation. 

Keywords 

ODD, OMPD, orphan, prevalence, rare  

Introduction 

A rare disease is, as implied, a disease that affects a relatively low number of patients in the population. Many (over 6,000) rare diseases have been identified to date, and it is estimated that 3.5% – 5.9% of the worldwide population is affected by these diseases. 72% of rare diseases are genetic, while others result from infections, allergies, and environmental causes. Due to the low prevalence of each disease, medical expertise is rare, and knowledge and effective care are extensively lacking. In the past, drug manufacturers would not invest in therapies for rare diseases as they could not cover the vast costs of drug development and profit from marketing drugs to such small groups of patients. Despite the urgent need for rare disease¹ medicines, they came to be known as orphans of health systems, as companies would not develop these medicines, and the patient was often denied proper diagnosis and treatment² of therapies for orphan diseases.   

In order to encourage the development, the US Food and Drug Administration (FDA)  launched programs to create financial incentives for developing these therapies. An “orphan designation” is granted for a drug/biologic developed to treat an orphan disease.  

Since their inception, orphan designation programs have successfully created incentives for developing orphan drugs. For example, in 1983, the US Congress passed the Orphan Drug Act (ODA) laid down in 21 Code of Federal Regulations (CFR) §316³ to create financial incentives for orphan drug developers. Since 1983, the Act has resulted in the development of more than 250 orphan drugs, which are available to treat a potential patient population of more than 13 million Americans². 

Orphan Drug Designation in the US 

To be eligible for Orphan Drug Designation (ODD) granted by the FDA, a drug or biologic product should be intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders. To be defined as a rare disease in the US, the disease should affect fewer than 200,000 people in the US (prevalence is <200,000 persons) or affect more than 200,000 persons but not expected to recover the costs of developing and marketing a treatment drug (drugs that will not be profitable within 7 years following approval by the FDA).  

How to Submit a Request for ODD Designation  

An application⁴ of ~30 pages is submitted to the Office of Orphan Products Development (OOPD) by a US representative⁵.  

The basic elements in US FDA orphan designation⁴ application  

• Administrative information 

• Information on the disease or condition: Pathophysiology, etiology, treatment options and prognosis 

• Scientific rationale that demonstrates the drug’s “promise” to treat, diagnose or prevent the disease/condition, e.g., drug description and mode of action relevant to disease/condition; proof of concept studies, in vitro and in vivo data, clinical studies relevant to drug and disease/condition (if available) 

• Regulatory status 

• Determining the population estimate to support that the disease is rare: calculate the number of patients in the US based on established literature references and current US population estimates to show prevalence is < 200,000  

The evaluation process takes a maximum of 90 days from application submission. The application can be submitted on any date.   

The benefits of a US FDA orphan designation  

• Potential 7-year marketing exclusivity after approval 

• Exemption from user fees (waiver of NDA/BLA user fees) 

• Tax credits for qualified clinical testing  

Annual report  

An annual summary of information on the status of orphan drug development should be submitted. These are short documents (~10 pages) submitted between 12 and 14 months from the date of initial designation acceptance annually. The summaries include a review of preclinical and clinical studies performed and planned, a short description of the investigation plan for the coming year, and any anticipated or current problems/difficulties in testing/potential changes that may impact orphan designation.  

Acronyms and abbreviations 

BLA, Biologics License Application; CARs, Cumulative Abnormal Returns; CFR, Code of Federal Regulations; FDA, [US] Food and Drug Administration; NDA, New Drug Application; ODA, Orphan Drug Act; ODD, Orphan Drug Designation; OMPD, Orphan Medicinal Product Designation; OOPD, Office of Orphan Products Development;  

References 

(1) EURORDIS Rare Diseases Europe. What is a rare disease? www.eurordis.org/information-support/what-is-a-rare-disease/ (accessed). 

 
(2) US FDA. Orphan Products: Hope for People With Rare Diseases. 2018. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/orphan-products-hope-people-rare-diseases (accessed). 

(3) US FDA. 21 CFR §316. 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=316 (accessed. 

4) US FDA. Recommended Tips for Creating an Orphan Drug Designation Application. 2018. https://www.fda.gov/media/111762/download (accessed. 

(5) ADRES Ltd. Guiding you through regulatory processes. https://adres.co.il/regulatory-affairs/ (accessed). 

About the authors 

Liron Gibbs-Bar, PhD, is an associate senior regulatory and scientific consultant at ADRES and ADRES EU. She has more than eight years of experience in regulatory affairs, including regulatory strategy, briefing packages, and clinical trial applications writing, as well as interactions with regulatory authorities.  
Dr. Gibbs-Bar has a PhD in developmental biology from the Weizmann Institute of Science. She can be reached at liron@adres.bio 

In May 2024, the FDA finalized a rule that will bring significant changes to the regulation of Laboratory Developed Tests (LDTs)*, marking an end to decades of enforcement discretion. Under this new framework, laboratories that manufacture nonexempt LDTs will be required to comply with medical device regulations, phased in gradually over the next four years. Stage One of compliance is fast approaching, with key deadlines and requirements set for May 6, 2025. 

*LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing. 

Here’s what laboratories need to know and do to stay compliant with Stage One: 

🔹 Medical Device Reporting (MDR) Requirements: 
By May 6, 2025, laboratories must comply with MDR regulations, which require reporting to the FDA any adverse events where an LDT may have caused or contributed to a death or serious injury, or if an LDT malfunctions in a way that could lead to harm. Even potential issues (e.g., design flaws or user errors) must be reported. Once a laboratory becomes aware of such an event, a report must be submitted within 30 days (or 5 days for urgent public health risks). Make sure your team establishes robust processes to identify, document, and report these events on time via the FDA’s Electronic Submissions Gateway. 

🔹 Correction and Removal Reporting Requirements: 
Labs will also need to comply with the FDA’s correction and removal requirements. Any corrective actions (such as repairs, modifications, or removals) taken to address health risks or unlawful activities related to an LDT must be reported to the FDA within 10 working days. Even if no report is necessary, detailed records must still be kept of all corrections and removals for FDA inspection. Now is the time to set up your system for tracking, documenting, and reporting these activities. 

🔹 Quality System Complaint Files: 
The FDA also requires that laboratories maintain formal Quality System complaint files. This means you must have a designated unit to manage and review complaints about your LDTs, ensuring that all complaints—both oral and written—are properly documented and evaluated. If a complaint relates to a potential adverse event, it may trigger additional MDR reporting. Make sure your complaint-handling procedures are solid, with thorough documentation and trend analysis capabilities to ensure compliance during FDA inspections. 

Who Needs to Comply? 

The FDA’s rule applies to most laboratories offering nonexempt LDTs. Some exceptions exist, such as: 

1. LDTs similar to those used in 1976, performed manually in a single CLIA-certified laboratory. 

2. LDTs used for human leukocyte antigen (HLA) testing in transplant activities. 

3. Forensic tests for law enforcement purposes. 

4. LDTs manufactured and used within the Department of Defense or Veterans Health Administration. 

However, if your laboratory offers any LDTs outside of these categories, it’s time to ensure compliance with the FDA’s Stage One requirements. 

Why Prepare Now? 

While there are ongoing legal challenges to the FDA’s authority over LDTs, including lawsuits from the American Clinical Laboratory Association (ACLA) and other groups, labs should not wait for these cases to be resolved before acting. It is unclear if the courts will rule before the May 2025 deadline, and waiting could lead to last-minute infrastructure investments and rushed compliance efforts. 

Setting up the necessary infrastructure for adverse event reporting, correction and removal systems, and complaint handling processes will take time. Start assessing your laboratory’s current capabilities now and develop an action plan to ensure you’re ready to meet these new regulatory obligations. 

Next Steps: 

1. Assess compliance needs: Evaluate whether your LDTs are exempt or subject to Stage One requirements. 

2. Implement reporting systems: Set up the processes and technology needed to meet MDR, correction, and removal obligations. 

3. Establish complaint procedures: Designate and train a formal complaint unit, and develop comprehensive documentation practices. 

4. Stay informed: Keep an eye on the evolving legal landscape and any updates from the FDA or courts that could impact your compliance timeline. 

The FDA’s rule represents a major shift for the industry, and the deadlines are approaching fast. Now is the time to get ahead of the curve and ensure your laboratory is fully compliant by May 6, 2025.  

The ADRES team is here to support you in ensuring your laboratory achieves full compliance with the latest FDA regulations.

While watching this movie might not be very helpful to a medical device company that wants to launch its product in the US, it will make you laugh. However, there are some truths in the movie that are worth noting. Coming to America with little preparation and knowledge can wind up in some precarious situations. The culture is different, and many of the rules, processes, and things that make the transition easier may not come naturally. 

For a medical device company contemplating launching in the US there are some things that are obvious. Regulatory compliance with the FDA is essential to sell any medical device in the US and this includes having an appropriate QMS (Quality Management System). There are numerous resources on this topic, and this of course is one area that we focus on. 

Many companies look at this hurdle as the first one to overcome in preparing to launch in the US. While it is necessary, it’s rarely the first step. 

Let us consider what the end goal is. In 100% of all our clients, the primary goal is to sell their product in the US. Gaining regulatory approval does not mean success in the market. So, what are the questions that need to be answered and how should we consider accomplishing that? 

First question: Is there a market? 

Just because the device might have been successful in other markets, or even because the device has a benefit to the patient, does not necessarily mean it will be purchased in the US market. There are multiple aspects to consider. It’s not as simple as “the surgeon will want this.” That could be true, and it’s important to have a champion that wants the product. This is usually a physician, nurse, or, in some cases, administration that makes their life easier. But it’s unlikely the champion is paying for the device. So, one has to always look at the economics of a purchasing decision. What value does it bring to the purchaser? Is it replacing something else?  

Customer discovery should always be at the forefront of the process. We generally put together a group of all stakeholders and determine who wants the product, who doesn’t want the product, and possibly most importantly, what are the healthcare economics around the utilization of the product.  

Second question: How big is the market? 

There’s also the question of how big the market is. Is it an existing market or an emerging market? Emerging markets take much longer to penetrate usually, but it also means the market hasn’t been penetrated. In existing markets, one has always to consider the possibility that while there might be a big market, it’s already saturated, and the available market is only a replacement market. This can happen when there’s good reimbursement and replacing a device that may only be a few years old offers no return on investment to the hospital. This goes back to understanding the economics of the purchase. 

Always evaluate the market thoroughly before going through the expense of getting cleared by the FDA. If there is no market or the market opportunity is very limited, it may not be wise to pursue it. 

Third question: Is there reimbursement? 

This is usually key to being able to scale sales in the US. There are often early adopters without reimbursement, but this usually doesn’t amount enough to establish stability in the market. Reimbursement is paramount, and if reimbursement does not exist, it’s likely that it will need to be pursued. There’s an article on the Reimbursement Strategies here (https://www.rivesconsult.com/post/reimbursement-strategies-for-early-stage-medical-devices) 

Reimbursement often has some very specific language on what qualifies for reimbursement, and this can be important for any regulatory filings. The regulatory claims need to be aligned with any reimbursement that will be pursued.  

We had one client come to us with claims of “prevention.” Prevention is not reimbursable, but early detection is. For this reason, we recommended changing their marketing stance to “early detection.” No changes were necessary for the device, only how it was positioned in the marketplace and the language that would be used for filing with the FDA. 

Fourth question: Who are the leaders in the field? 

Particularly for early-stage innovative devices, we always recommend working with leaders (KOLs) in the field. These leaders can often help with everything from reimbursement to clinical trials, but they can also be part of a medical advisory board. This is a good article on the importance of a medical advisory board. (https://tincture.io/how-to-build-an-effective-medical-advisory-board-in-seven-steps-59eb92e794ce) 

We always recommend embracing these leaders. They’ve spent their career in the area where your device is relevant, and they can be of tremendous value in not only helping you launch your product but also in advising on the ongoing development of the product. They can also help point out pitfalls and obstacles you may have in successfully gaining market share. 

Fifth question: What are the indications for use and intended use? 

This will be a primary part of an FDA application. If there is reimbursement, this must be aligned with how likely it is to get reimbursed. We always stress the importance of considering this very carefully, including the possibility of limiting the indications for use and intended use beyond what one may consider the broadest market. Let’s say, for example, the device tends to have a bigger effect on more older adults, perhaps 65 and older, but there is also some evidence that it can have a good effect on anyone over the age of 40. A study to include the whole potential patient population may be significantly larger and more expensive and must be weighed against the market sizes. In some cases, it makes sense to enter the market with narrower indications for use and intended use and then add additional studies and do a subsequent filing with the FDA to expand these later.  

When working with the FDA, it is important to have someone with experience and a good relationship with the FDA. Many people see the FDA as a barrier to entry, and while to some degree that’s true, the FDA is not trying to keep companies and devices from entering the market. They are only ensuring that they are safe and effective, with an emphasis on safety. If a device has an additional risk to patients, those risks will need to be outweighed by the potential benefits to the patient. In our experience, the FDA has been very open and easy to work with, particularly with early-stage innovative companies.  

Another aspect of working with the FDA is understanding some of the subtleties in the language used. Two phrases may appear to have the same meaning, such as being cleared or approved by the FDA. However, being cleared and approved are two different things to the FDA. A 510(k) application is cleared to market, and a PMA application is approved by the FDA. Another often misunderstood word is labeling. Many think this is the label that goes on the device, but to the FDA, labeling is everything about the device, including instructions for use, the operator’s manual, safety requirements, storage requirements, training materials, etc. Subtle wording in indications for use and intended use can make significant differences not only in reimbursement but also how one can market the product.  

Sixth question: Do you need a clinical trial or usability study? 

Oftentimes, one of these is necessary for FDA clearance. Usually, the KOLs can assist with this, or in some cases, if there is the need for a large clinical study, such as a PMA application, employing a CRO can help. One thing to note, though, with CROs is they are not working to build a relationship with KOLs. Their job is to get a clinical study accomplished. So, it’s important to understand this and manage expectations. Another very important aspect of working with a CRO is being sure you have the right CRO and staying on top of monitoring or overseeing their process. A CRO that’s too big for a company or set up for therapeutic trials is probably not the right fit for an early-stage innovative medical device company. We recommend interviewing and getting quotes from multiple CROs and interviewing them before making a decision on who to work with. Our company decided to hire an expert who had run a CRO previously to do this for our clients. 

Seventh question: How are you going to get your first five sales? 

You will never scale a business if you can’t get the first five sales. So, what does it take to get those sales? Who is your champion? Who or what are the obstacles to getting the sale? Selling into hospitals is complex, and the bigger the hospital system, the more complex it tends to be. On top of that, you’re a new vendor, and purchasing is not thrilled about qualifying and adding vendors. Are you connected to the hospital network? Is patient information part of the data connected to the network? Another hurdle with IT in the hospital to address.  

One of the biggest challenges for new innovative device companies can be a change in workflow. If the device is truly unique and is not replacing another device, there is almost definitely a change in workflow. This can be a barrier to entry and has to be handled appropriately. We often use the analogy of changing workflow in a healthcare setting, which is a little like steering an iceberg. It can be done, but it isn’t easy, and it takes time. Change in workflow almost always comes with some resistance, and one must understand what that is and how to overcome it.  

We generally recommend getting these first sales directly. You need firsthand knowledge from some different institutions about what it’s going to take to achieve sales. Channel distribution can be effective down the road once you have the formula for a successful sales transaction. 

Eighth question: What are the resources necessary to launch? 

What kind of personnel will you need in the US initially to sell, train, and support the product? Most clients from Europe that have been successfully selling in the EU have a pretty good handle on this. But if one has not been selling or is selling very early in selling in another location, then it can be more difficult. The sales side is fairly simple, particularly if a soft launch is the plan. The service side can sometimes be more daunting as it often needs the expertise of engineers within the company. How will service calls be handled initially and ultimately resolved? How much additional staff is needed to accomplish this?  

What are the hours of needing to have customer service support? In use, we generally recommend from 8 am Eastern time to 5 pm Pacific time Monday through Friday for devices that are not used in emergency situations. For devices used in emergency situations, support may need to be available 24/7.  

Once these questions can be answered at least to a reasonable level of certainty, a financial proforma can be refined for resource planning. 

Ninth question: What did I not think about? 

This is one of the most important questions. The first eight questions will probably seem somewhat obvious and necessary to launch a medical device in the US, but what are the things needed to execute it that have been overlooked? These are often the details that can be critical if not addressed. Many of the details have to do with some basic aspects of selling medical devices in the US. First, there is the issue of having an Initial Importer by the FDA. This is similar to the function of a EU representative in the European Union. One solution is to set up a subsidiary for the parent company, but there are other solutions involving outsourcing this to companies based in the US. What is optimal in terms of manufacturing? Importing in the US can be expensive and needs to be considered.  

Also, there are HR (human resource) requirements and compliance for HR. These can include certain legal requirements, such as having appropriate workers comp insurance to paying and withholding required taxes. 

Some other items that must be considered are liability insurance, which protects the company should anything go wrong. Hospitals are also generally required to purchase the product. They want to be sure they are protected should anything malfunction. Logistics and planning on how to ship, receive, and install the technology, as well as have timely training. Other taxes and registrations are required for both sales tax, medical device tax, and possibly import taxes and duties. 

Summary: 

I’d love to say this is a full, comprehensive list of everything that needs to be considered when planning to launch a medical device in the US, but it’s not even close. It is a good high-level overview of the main areas that need to be considered and hopefully is helpful to anyone on the journey of Coming to America! 

In January 2025 Donald Trump was sworn as the next US President for the 2nd time. We are looking closely to check how it will affect the U.S. biotech market as it could experience both opportunities and challenges, influenced by his administration’s policies and priorities.  

Our analysis provides a balanced perspective on potential scenarios that are based on our knowledge of his policy during his first term in office. 

1. Continued Support for Israel 

* Strong US-Israel Relations: Trump has been a strong advocate for Israel, and a second term would likely continue this trend. The U.S. government might offer increased support for Israel’s biotech sector, especially through R&D collaborations, funding, or government-backed initiatives. 

2. Regulatory Environment  

* Reduced Regulations: Trump’s administration has been known for deregulation, which may positively affect biotech companies by easing approval processes for new drugs, treatments, and technologies. A second term could encourage similar regulatory relaxations that may benefit biotech companies in Israel, especially those looking to market their products in the U.S. 

* Drug Pricing Pressure: However, Trump previously expressed support for lowering drug prices, which could create uncertainty for biotech firms reliant on high margins from innovative therapies. Policies targeting drug price transparency or Medicare reforms could pressure profits.  

3. Trade and Global Collaborations  

* China Relations: Trump’s tough stance on China might further impact biotech partnerships, supply chains, and R&D collaborations, given the strong ties between U.S. biotech firms and Chinese investors or manufacturing.  

* “America First” Policies: Increased incentives for domestic biotech manufacturing and innovation could benefit U.S.-based firms but might strain global biotech integration.  

4. Government Investment and Public Health  

* Pandemic Aftermath: The biotech industry saw a surge in funding and innovation during the COVID-19 pandemic. If Trump’s administration prioritizes pandemic preparedness or biomedical innovation as part of a broader health policy, this could mean sustained investment in key areas like vaccines, gene therapies, and precision medicine.  

* NIH and R&D Funding: Federal funding levels for research institutions like the NIH may depend on budgetary priorities. Trump’s historical focus on defense and tax cuts might limit these investments, but targeted programs like Operation Warp Speed demonstrate potential exceptions.  

5. Investor Confidence and Market Dynamics  

* Volatility: Political uncertainty or sudden policy shifts during a second term could create market volatility, affecting investor confidence in the biotech sector.  

* M&A Activity: Deregulatory policies could stimulate mergers and acquisitions within the biotech space, as larger players look to acquire innovative startups.  

* Private Investment: Trump’s administration has emphasized private sector-led growth. Israeli biotech firms might see more venture capital inflows from American investors who may be more comfortable under Trump’s policies compared to a more regulated environment. This could lead to increased investments in Israeli biotech firms, particularly those focusing on cutting-edge treatments, medical devices, or AI-related biotech. 

* Pharmaceutical and Biotech Collaborations: Israeli biotech companies might benefit from greater partnerships with U.S.-based pharmaceutical giants, particularly if Trump fosters environments favorable to industry collaboration. Israel’s reputation as a hub for innovation in fields like personalized medicine, cancer research, and digital health could make it an attractive partner for major U.S. pharmaceutical companies. 

6. Diplomatic and Security Considerations 

* Middle East Peace Initiatives: Trump’s peace initiatives, like the Abraham Accords, could indirectly benefit Israeli biotech companies by fostering regional stability. This might open up new opportunities for Israeli biotech collaborations with countries in the Middle East and North Africa. 

* Geopolitical Stability: A Trump presidency might emphasize security in the Middle East, which could positively impact the Israeli tech ecosystem by promoting a stable environment for innovation and foreign investments. 

Our overall outlook of the post-election biotech market under Trump’s second term could be a mixed bag. Deregulatory policies and domestic incentives might provide growth opportunities, but pressures on drug pricing and geopolitical tensions could dampen enthusiasm. For investors, the focus might shift toward companies with diversified portfolios, strong pipelines, and the ability to adapt to pricing and regulatory shifts. 

About: The California Israel Chamber of Commerce (CICC) is a nonprofit, industry-supported organization dedicated to promoting and strengthening the technology and trade relations between business communities, curating educational programs, and providing opportunities for industry stakeholders to network with like-minded. 

For 25 years, our activities have benefited the Israeli and Californian business communities and influenced thousands of founders, investors, researchers, and individuals. For more market insights and support, please contact info@ci-cc.org 

Startups, especially in the health tech sector, face an ever-evolving challenge: continuously attracting investors while engaging partners, customers, and stakeholders. To succeed, they need a marketing and communications infrastructure built on two foundational pillars: a well-defined communications strategy and exclusive branding. 

The Communications Strategy 
Grounded in Business and Differentiation “Storytelling is the most important skill a communicator can have,” notes Mike Nachshen, president and owner of Fortis Strategic Communications. Yet a solid communications strategy must rest on a robust understanding of your business model. This means knowing not just what you do, but why it matters to your audience, especially investors, and how it stands out in the competitive landscape. 

The process begins with an in-depth audit of your startup’s scientific, corporate, and product information, alongside a comprehensive analysis of the competitive landscape. It is crucial to examine competitors’ value propositions, taglines, and key terminology in order to develop a substantial differentiation in relation to your competition. These insights will help you position your offering when crafting your messaging framework. Your strategy should clearly articulate the unmet need, your solution, and your unique value proposition in the context of the market. Once you have your communication strategy or your branding roadmap, all other activities across the company should align. 

Exclusive Branding – Not Just a Logo  
With strategy defined, branding brings your story to life. In health tech, it’s not enough to rely on generic visuals like clinical settings or molecular diagrams. Focus on creating imagery that reinforces your strategy and values. Choose colors that symbolize trust and innovation, fonts that suggest clarity and professionalism, and images that inspire confidence. Your branding should be as distinct as your messaging. 

From Foundation to Execution  
Apply these elements consistently across all communication channels, such as websites, investor decks, one-pagers, and presentations. Every interaction should reflect your cohesive narrative. 

For startups navigating the complex demands of attracting investors and engaging stakeholders, strong marketing and communications infrastructure isn’t optional—it’s essential.