Digital Health Consulting

As a consultant, the digital health industry has always fascinated me.

From one born and raised in the pharma and medical industry, I saw the complete cycles from conventional drug development, through the more sophisticated biological drugs and medical combination products, to the fascinated technology era, big data, AI, and AR.

The hi-end digitalization technology is fused into the medical science world. It makes its way into our conservative science and health world, becoming a great promise to health and well-being and will change the health perspective forever.

With more than 20 years of experience in the science, biotechnology, and Bio-Medical industry, I have led many Bio-Med and E-Health companies in different aspects throughout their journey.


What consulting services a digital health company may need?

The E-Health industry is diverse. I have consulted for many kinds of E-Health companies. It can be clients using data analysis, process imaging, with or without a medical device (SaMD Vs. SiMD), G5 mobile, wearables, Big data analysis tools, artificial intelligence, augmented reality, deep learning, and more.

This high-technology has to meet strict regulatory requirements in order to be a “real medical device” that it’s claim can be clinically proven in order to have it’s CE mark and FDA approval for being able to sell worldwide.


So- what are the consulting services that digital health companies usually need?

  • Market analysis
  • E-Health strategy
  • Development
  • Good practices
  • Clinical evaluation
  • Risk Assessment
  • Regulatory strategy
  • Information security and confidentiality
  • Quality management system
  • Verification & Validation
  •  510K and CE certification
  • and sales


Besides bringing a new technology that eases patients’ pain and making medical treatment available for and affordable for everyone, part of my clients also had impressive “EXITS”, being bought by big pharma and Bio-Med players.

I was lucky to be based in Israel and exposed to two technological hubs, global leaders, the Hi-Tech and the Biotech ones, gaining precious knowledge and experience that I can share with new E-Health companies.

My philosophy in the digital health world is- “every side of the deal should do what he is good at”, or in other words, you will do your hi-tech things the best you can, and I will be your consultant to make it happen in our E-Health world.

Let me know what you want it to be, and I will advise you on how to do it.


What should you ask yourself before hiring E-Health consulting services?

Based on hundreds of Bio-Med companies I have consulted to, in most cases, digital health companies employed the wrong team members and spent specious time and money on them, which could have been invested better.

There is no digital health company that can succeed without professional support and consultancy (in particular critical  stages) from health industry experts who have the know-how from both the conservative Bio-Med world and the software, And technology.

There are many consultants in the BioMed industry, so choosing the right one for your needs to be done thoughtfully and cautiously.

Here are some expert questions you should ask when considering different options that will assist you in carefully choosing the right consulting services for your digital health ideas.


How to choose the best digital health consultancy

  • Does your consultant have the right experience?
  • Has your consultant worked with many global and multinational clients?
  • Does your consultant have combined health, medical technology, and information
  • Does your consultant have practical regulatory know-how?
  • Does your consultants’ track record include regulation-related positions?
  • Does your consultant “see the whole picture” and are they experienced with the clinical, development, and commercialization stages?
  • Is your consultant multi-skilled, and can they support your specific needs every step of the way?
  • Does your consultant have a broad professional Bio-Med network that can benefit you?


The digital health industry’s most significant innovations and success stories started from small R&D companies relying on professional and reliable long-term consulting services and support.

E-Health consultancy usually begins in the early medical software development stages, proof of concept, and moves to the clinical trials and evaluation until the marketing approval is in place.


Digital health development consultancy

A successful digital health product/service development process is a unique combination of innovation, safety, security quality, and regulatory compliance.


Digital health products and services categories

The E-Health industry has made some huge steps over the past decade, including:

  • Software as a Medical Device (SaMD)
  • Software is a Medical Device (SiMD)
  • Decision supportive tools
  • Surgery robotics and automation
  • Telecare
  • Telemedicine
  • Mobile health apps and wearable
  • Health-related data analysis and monitoring
  • Early diagnostics
  • Digitized health system
  • AR and telesurgery
  • Preventive medicine
  • Personalized medicine
  • Precise medicine


Indeed, technology is a significant factor, but as part of my digital health consultancy, I tend to integrate clinical, quality, and information security considerations alongside long-term thinking and concern for the later stages of the project.

At the end of the day, all digital health products and E-health solutions need marketing approval from the FDA and the CE or at least due diligence, and we need to set those foundational stepping stones early on in the development phase.

All my Bio-Med and E-Health consulting projects have involved innovative orientation alongside setting the boundaries when needed to comply with the various CE, ISO and FDA regulations fully.


Digital health strategy consultancy

With the advent of digitalization, big data, and AI developments, similar changes are taking place in the health sector as well.

In this day and age, the global digital health market is an eclectic mix of heterogeneous, innovative, dynamic, and fascinating. This sector demonstrates high growth rates and endless potential in the larger context of the global economy and health systems. The Covid-19 pandemic in 2020, did indeed give the E-health industry a boost that is becoming increasingly clear.

The global E-Health industry offers various solutions, services, and products for the good of humanity to improve the quality of life.

Although the global E-Health industry is not very competitive, the correct approach and strategy need to be in place to convert potential into a success story. Defining a clear plan to find the best niche for your innovative Digital health solution and implementing your tactic accordingly is mandatory.

I have consulted many skilled software developers and data scientists from various fields of expertise, including Big Data, Data Analysis, Machine Learning, automation, and Artificial Intelligence, who bring brilliant and unique ideas to the budding E-Health industry.


Strategic consulting milestones for E-health companies

Strategies for E-health companies need to be built based on well-defined methodologies. This includes landmarks such as:

  • Risk Analysis
  • Market analysis
  • Competitors
  • Clinical strategy
  • Regulatory strategy
  • Target market Local regulation and Insurance coverage policies


I always advise my digital health clients to think creatively and find the best way to dominate a larger market share with less regulatory complexities.


Digital health regulatory consultancy

The regulatory requirements for E-health solutions are stringent compared to other industries.

As part of my digital health consultancy, I’m working closely with my clients, primarily concerning the risk, safety, and effectiveness aspects to be integrated into the technical file before submission to the FDA, CE, and have the proper Information Security certifications in hand.


Digital health pre-submission consulting outcomes

It goes without saying that many tests need to be carried out on digital health products before they can be approved, regulated, and brought to market.

Here are some important milestones for consideration:

  • Proof of concept
  • Development & Commercialization strategy
  • Clinical strategy
  • Market analysis strategy
  • Risk assessment
  • Design control
  • Clinical evaluation
  • Verification
  • Validation
  • Global regulatory strategy
  • Data integrity
  • HIPAA & GDPR compliance
  • Preparations towards regulatory inspections
  • ISO 13485 & 21 CFR 820 QMS
  • ISO 27001/17 certification
  • Technical file establishment
  • CE marking
  • FDA approval
  • Post marketing


Usually, there is no second chance when it comes to gaining approval from the various global regulatory bodies, so it’s vital to get things right the first time around.

My recommendation is that you employ consultants with a holistic approach, have multi-areas of expertise, as well as broad and robust experience to assist you from ‘concept to sale.’


Digital health quality management consultancy

To bring a safe and effective E-Health solution to market, you must be aligned with industry-standard regulatory requirements and good practices.

In parallel to the digital health product or service development phase, you need professional quality and GxP consulting to establish your company’s quality management system to ensure it is set up right for the short and long term.

Firstly, with your Digital health QMS consultant, you need to define what kind of quality management system will support your business goals best.


What type of Quality System will serve you best?

The quality management system you should adopt in your E-Health company depends on several factors, including:

Factor Examples
Technology type
  • Decision supportive tools
  • Surgery robotics and automation
  • Telecare
  • Telemedicine
  • Mobile health apps and wearable
  • Health parameters analysis and monitoring
  • Early diagnostics
  • Digitized health system
  • AR and telesurgery
  • Preventive medicine
  • Personalized medicine
  • Precise medicine
Digital health product type
  • Decision supportive tool
  • SaaD
  • SaMD
  • SiMD
  • IVD
  • Treat/diagnose
  • Clinical management
Associated health condition
  • Critical
  • Serious
  • Non-Serious
Risk level
  • High risk
  • Mid risk
  • Minor risk
  • No risk
E-health solution classification
  • Self-declaration
  • Class I
  • Class IIA
  • Class IIB
  • Class III
  • De-Novo
  • PMA
E-health solution categorization
  • 510K
  • De-Novo
  • IVD
Target markets
  • US
  • Eu
  • Canada
  • Japan
  • Australia
  • UK
  • Rest of the world
Regulatory requirements
  • ISO 13485:2016
  • 21CFR part 820
  • ISO 14971
  • IEC 62304
  • IEC 62366
  • IEC 60601
Territory/local regulations Based on the specific territory
Potential business partners and clients
  • Big pharma
  • VCs
  • Governmental bodies
  • Academy
Potential end-users
  • Physicians
  • Clinics
  • Pharmacies
  • Home/ personal use

Global regulations, including those set and stipulated by the FDA, CE, and others, require an effective quality management system to ensure that E-Health services were tested on users as part of the clinical evaluation and for commercial use are safe and effective.


What are the main pillars of a Quality Management System?

A Quality Management System is a methodology that needs to be implemented and assimilated into an organization correctly. The main quality management system pillars are detailed below:

  • Risk-based approach
  • Criticality
  • Control
  • Electronic Medical records security
  • Documentation
  • Consistency
  • Traceability
  • Data integrity
  • User’s feedbacks
  • Continuous improvement


As part of the digital health quality management system consulting phase, I analyze any gaps in quality, establish an SOP template for you and write all your policies and procedures tailored to your company’s needs from your E-Health development phase, business goals and beyond.

After documents have been approved, I will train all relevant employees, and we will begin to assimilate the procedures into your company’s day-to-day activities or enterprise.

As part of the E-Health QMS consulting process, I always tell my clients that all activities in the company have to be correctly and specifically defined and documented accordingly.

At the conclusion of the digital health quality management consulting phase, I will conduct a mock audit ahead of the third-party external audit to maximize the quality certification’s chances as soon as possible.


Digital health Information security consultancy

We are all aware that the company’s business information, clinical data, and patient’s health records must be secured and guarded. In case of a breach, there is no way to go back in time, and you are exposed to very high business and regulatory risks.

We need to establish proper safeguard mechanisms, procedures, and technologies to secure critical information and prevent data leakage.


Information security management systems can comply with regulatory standards such as:

  • GDPR
  • ISO 27001
  • ISO 27799
  • ISO 27017
  • SOC-2
  • NIS Directive
  • Hi-Trust


What are the main pillars of an Information Security Management System?

An Information Security Management System is a methodology that needs to be implemented and assimilated into an organization correctly.

The main ISMS pillar:

  • Data base management
  • Risk Management
  • Human resources
  • Supplier qualification
  • Data integrity
  • Authorization and password management
  • Information encryption
  • Physical security
  • Communication and network
  • Monitoring
  • Security incidents management
  • Business continuity
  • Electronic Medical records security
  • Documentation
  • Continuous improvement


As part of the digital health information security management system consulting phase, I analyze any gaps in the security, establish an SOP template for you and write all your policies, procedures, and agreements tailored to your company’s needs.

After documents have been approved, I will train all relevant employees, and we will begin to assimilate the procedures into your company’s day-to-day activities or enterprise.

As part of the E-Health ISMS consulting process, I always tell my clients that all necessary safety precautions implemented in the company must be correctly, precisely defined, and documented accordingly.

At the conclusion of the digital health information security management consulting phase, I will conduct a mock audit ahead of the third-party external audit to maximize the chances of having the relevant certification as soon as possible.


Digital health QMS and ISMS lead auditor

What type of auditor services is right for you?

Second and third-party audits are a common practice in the digital health industry.

On the one hand, you will need to be audited by regulatory agencies and business partners, while on the other, you need to audit your partners, service providers, and suppliers.

Here are some audit types that should be performed:

  • Service providers’ audits
  • Information security audits
  • Quality management audits


To ensure you choose the best partners along the way to meet your requirements, you need auditing capabilities, professional consultancy, and proper guidance.

Moreover, the QMS regulations require you to qualify and approve your suppliers before authorizing them.

I’m a certified ISO 13485 and ISO 27001 lead auditor, recognized and accredited by the global NSF, IRCA, and CQI, with a proven track record of many first and second-party audits worldwide.

I offer my clients my lead auditor capabilities as required.


Digital health consulting Summary

When it comes to the Digital health industry, a few things are more important than choosing the right business partner to suit your own specific needs.

The journey of a novel E-Health technology, from the development phase until your medical claim was clinically proven and a compliant end product in line with regulations has received marketing approval, is a long one. It requires patience, sufficient budget, multidisciplinary skills, in-house professionalism, and professional consulting.

You have two options before you achieve your goals. One is to possess all the relevant technological, health, and medical skills, knowledge, and practical experience yourself; the second is to use digital health consulting experts with the right know-how and expertise.

To reach your goals effectively, you will need E-Health consulting services at several points in the process. Hiring the right digital health and BioMed consultant will surely save you precious time and money every step of the way.

A highly experienced consultant from both the Bio-Med and E-Health worlds will add value from start to finish, especially if they possess the relevant regulatory requirements know-how and have consulted for hundreds of different Medical and digital health clients over the years.

I have 20 years of experience in Bio-Med and E-Health consulting and supporting novel medical software and services development and startups. I proudly assist them along their journey, all the way through to gaining regulatory marketing approval.

I’m here to support and consult  Hi-Tech technologies entering the Bio-Med industries, committing to a high standard of consultancy.

I invite you to contact me today for a full consultation. It will be my pleasure to meet you. 

Contact me today
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