Expanding into the Israeli market with Medical Devices and E-Health services holds great promise due to the thriving healthcare ecosystem. However, this endeavor is fraught with potential risks and challenges.
Many companies unwittingly fall into common pitfalls that can derail their efforts.
In this article, we will explore these risks in depth and offer insights on how to mitigate them.
Distributor as an Israeli Registration Holder
One of the most significant and perilous mistakes is appointing the distributor as the registration holder.
Distributors and local registration holders are distinct roles, each requiring unique skills, responsibilities, and objectivity.
Using the distributor as the registration holder may seem convenient at first, but it can lead to complications down the road.
Should disputes arise, business arrangements change, or you decide to switch distribution service providers or strategies, you risk losing control over your Medical Device/SaMD distribution in Israel.
To circumvent these risks, it is strongly advised to designate an independent, professional registration holder who will defend your business goals in the Israeli market.
This expert will represent your interests, providing objective and professional counsel. Their role is to ensure the stability and profitability of your business activity in the Israeli market while upholding compliance with Israeli Ministry of Health regulations.
Nonprofessional Israeli Bio-Med Consulting Company
Relying on an inexperienced or nonprofessional consulting company for device or service registration can be a burdensome mistake.
These consultants may lack the necessary expertise and years of experience in the global Medical Device and E-Health industries.
Their shortcomings can lead to significant delays and complications in the approval process, potentially putting your market entry in jeopardy.
Opt for a reputable consulting firm with a proven track record of successful registrations to streamline your registration process.
Nonprofessional Local Israeli Registration Holder (IRH)
Collaborating with an unprofessional local registration holder poses serious risks to your ability to sell medical devices and digital health services in Israel.
These individuals or entities play a pivotal role in maintaining compliance with the Israeli Ministry of Health (IMOH).
An inexperienced or non-compliant registration holder can expose your business to various risks.
To ensure your operations remain secure, prioritize reliability and expertise when selecting your registration holder.
Conflict of Interest
Choosing a distributor with conflicts of interest can significantly hinder your expansion efforts.
When a distributor simultaneously works with competing devices or services, it may not give your Medical Device or service the undivided focus it deserves.
To maximize your market potential, partner with a distributor dedicated exclusively to your offerings, thereby reducing potential conflicts and safeguarding your interests.
Upholding confidentiality is of paramount importance when working with a Medical Device distributor. During the device or E-Health service registration process and ongoing registration holder services, your company exposes sensitive business information.
This includes technical details, engineering specifications, technological features, and proprietary formulas.
Such confidential information should be shared exclusively with companies specializing in Device and Digital Health service registration and local registration holders.
These entities should have minimal conflicts of interest and provide professional services.
Implementing stringent confidentiality agreements and protocols and separating device/health service registration activities from distribution activities is crucial to safeguarding your proprietary information while collaborating with distributors.
Language barriers can impede communication and collaboration with your distributor, resulting in misunderstandings, misinterpretations, and communication gaps.
This is particularly concerning regarding ongoing registration holder activities conducted with multi-regions subject matters outside Israel and within the Israeli Ministry of Health.
To prevent errors and delays, ensure that your distributor’s team is proficient in your preferred language and well-versed in the specific terminology, knowledge, and proven professionalism in your industry.
Entrusting your medical devices or E-Health services to an unreliable distributor, consulting firm, or registration holder can lead to missed opportunities and damaged relationships. Reliability forms the bedrock of successful distribution.
Choose registration holders and distributors with proven records of dependability, timely deliveries, and excellent customer service.
Misallocated Marketing Budget
Inappropriately allocating your Medical Device and E-Health service marketing budget is a frequent blunder.
Each company possesses unique devices, technology, business goals, and target audiences. Deploying a generic or misaligned marketing strategy can squander resources and fail to generate desired results.
To optimize your marketing efforts, work closely with your distributor to create tailored marketing strategies that align with your specific business needs and objectives.
Neglecting Post-Market Surveillance
Neglecting to establish a robust post-market surveillance system can result in inadequate monitoring of Medical Device and Medical software performance, adverse events, and non-conformities.
A deficiency in post-market surveillance can lead to unnecessary product recalls and put your Israeli registration license at risk.
It is imperative to have a well-established, professional, and reliable Israeli registration holder to ensure smooth operations and business continuity in the Israeli market.
Ignoring Israel’s Medical/Health Market Research
Although the Medical and Health industry in Israel demonstrates high growth rates and accessibility to novel medical treatments, insufficient knowledge of the local market, including customer preferences and competitive landscapes, can lead to ill-informed strategic decisions.
Engage your local registration holder, who acts as an objective third party, to provide guidance on the opportunities, competitors, and risks present in the Israeli market.
Overlooking Regulatory Changes
As with health authorities worldwide, the Israeli regulatory landscape is subject to change, impacting your distribution process.
Staying informed about and promptly addressing regulatory changes is crucial for maintaining compliance with Israeli Ministry of Health regulations and laws.
Ensure that your Israeli registration holder possesses the regulatory capabilities to support your long-term compliance.
Inadequate Training and Support
Neglecting to provide comprehensive training and support to your local team can hinder effective product promotion and customer support.
Verify that all your service providers in the Israeli market, including distributors, marketing personnel, and registration holders, have received appropriate training and possess the knowledge required for effectively representing your device, service, or technology.
Misunderstanding Reimbursement Mechanisms
Inaccurate pricing and reimbursement strategies can significantly affect your market positioning.
Israel offers various subsidization plans for drug products, medical devices, and health services.
It is advisable to explore whether your device or service qualifies for any of these subsidization plans to maximize market penetration.
Collecting, analyzing, and acting upon feedback from customers and healthcare professionals is essential for improving your product or service’s performance.
Failure to do so not only risks regulatory compliance but also the opportunity for product enhancement and trust-building in the market.
Typically, this is performed as part of the Israeli registration holder’s services according to marketing surveillance plans and procedures.
Successful distribution of medical devices and E-Health services in the Israeli market demands meticulous planning and adherence to best practices.
Avoiding common mistakes, such as using a distributor as a registration holder and working with nonprofessional consulting companies, is pivotal for a smooth market entry.
In addition to these pitfalls, addressing challenges related to language barriers, reliability, marketing allocation, and embracing effective post-market surveillance is crucial to maximizing your chances of success.
By maintaining vigilance and proactivity, you can successfully navigate the complexities of the Israeli market, unlocking its full potential for your products and services.
For comprehensive guidance in establishing a robust presence in the Israeli market, reach out to our expert team.
We specialize in providing objective, professional, and reliable services to ensure your success in Israel.
Don’t let these risks hinder your expansion—take the first step towards a thriving presence in the Israeli healthcare ecosystem.