Medical Device Sales

24 Jul Medical Device Sales

A Comprehensive Guide to Medical Device Sales: From Development to Market

In today’s rapidly evolving healthcare landscape, the sale of medical devices represents a crucial aspect of the medical industry, contributing significantly to advancements in patient care and treatment. For startups entering this competitive market, understanding the intricacies of developing, certifying, and selling medical devices in the US and EU is vital. This guide provides an in-depth look at the essential steps and considerations for successfully navigating the journey from development to market.

Understanding the Medical Device Market:

Market Overview

The medical device market is a dynamic and highly regulated sector with substantial opportunities for innovation and growth. According to industry reports, the global medical device market is expected to reach $612.7 billion by 2025. The US and EU markets represent significant portions of this global market, driven by advanced healthcare infrastructure, increasing prevalence of chronic diseases, and growing demand for innovative medical technologies.

Key Players

The market comprises various key players, including multinational corporations, mid-sized companies, and startups. While established companies have the resources and experience to navigate the complex regulatory landscape, startups bring fresh perspectives and innovative solutions. Understanding the competitive landscape and identifying potential collaborators or competitors is essential for market entry.

Step 1: Concept and Feasibility

Identifying a Medical Need

The journey begins with identifying a significant medical need or problem that the device aims to address. Conduct thorough research to validate the clinical need and potential market demand. Engaging with healthcare professionals and potential users can provide valuable insights into the device’s practical applications and potential impact. On the other hand, also a very clear definition of the intended purpose of the devices is a very important step. The intended purpose of a medical device defines its specific function and application in healthcare, outlining what the device is designed to do, who will use it, and the conditions under which it will be used. This is a critical aspect of the device’s development and regulatory approval process, as it directly influences the device’s classification under both US and EU regulations.

Concept Development

Once a medical need is identified, focus on developing a concept for your medical device. This involves brainstorming sessions, prototyping, and initial design iterations. Consider factors such as user-friendliness, functionality, and cost-effectiveness during the concept development phase.

Feasibility Analysis

Conduct a feasibility analysis to assess the technical, clinical, and financial viability of your concept. This involves evaluating the technical challenges, regulatory requirements, market potential, and cost considerations. A comprehensive feasibility analysis helps in making informed decisions and refining the concept.

Step 2: Research and Development

Design and Development

The design and development phase is critical in transforming your concept into a tangible product. This involves detailed engineering, design validation, and iterative testing. Collaborate with experienced engineers and designers to ensure the device meets the required specifications and standards.

Prototyping and Testing

Develop prototypes of your medical device and conduct rigorous testing to evaluate its performance, safety, and usability. This includes bench testing, preclinical testing, and usability testing with end-users. Document all testing procedures and results meticulously to support regulatory submissions.

Risk Management

Implement a robust risk management process to identify, assess, and mitigate potential risks associated with the device. This involves conducting risk assessments, developing risk mitigation strategies, and continuously monitoring and managing risks throughout the development lifecycle. ISO 14971 and ISO/TR 24971 are helpful standards to document and proceed it in the correct way.

Step 3: Regulatory Compliance

Understanding Regulatory Requirements

Regulatory compliance is a critical aspect of medical device development and sale but also often one of the most challenging activities a medical device company has to do. Having a great understanding of the required laws and regulations with a regulation plan on how to certify and register the product on a specific market can speed up the process and save a lot of money. Therefore we recommend using the AI-driven Regulatory Affairs Assistant called Elly. Elly can support you in the first steps to figure out the regulations and standards that are potentially necessary and give you helpful advice on how to register products at the FDA or in Europe. To get a first understanding and overview here are the regulatory requirements in the US and EU that are essential for successful market entry.

US Regulatory Pathway

In the US, the Food and Drug Administration (FDA) regulates medical devices. The regulatory pathway depends on the device classification:

• Class I Devices: Low-risk devices requiring general controls.
• Class II Devices: Moderate-risk devices requiring general and special controls, including premarket notification (510(k)).
• Class III Devices: High-risk devices requiring premarket approval (PMA).

Conduct a thorough review of FDA guidelines and determine the appropriate regulatory pathway for your device. Prepare the necessary documentation, including device descriptions, risk analyses, and clinical data, to support your regulatory submissions.

EU Regulatory Pathway

In the EU, the European Medicines Agency (EMA) and national competent authorities regulate medical devices under the Medical Device Regulation 2017/745 (MDR). Devices are classified into four classes (Class I, Is, Im, Ir, IIa, IIb, and III) based on risk levels. Key steps include:

• CE Marking: Obtaining CE marking is mandatory for market entry in the EU. This involves demonstrating compliance with MDR requirements through clinical evaluation, risk management, and quality management systems.
• Notified Bodies: Engage with a notified body (class I products exempt) to assess conformity and issue the CE certificate.

Quality Management System (QMS)

Implementing a robust Quality Management System (QMS) is essential for regulatory compliance. Adhere to standards such as ISO 13485, which outlines the requirements for a comprehensive QMS for medical devices. Ensure your QMS covers all aspects of design, development, production, and post-market surveillance.

Step 4: Clinical Evaluation and Trials

Clinical Evaluation

Clinical evaluation involves assessing the clinical performance and safety of your medical device based on clinical data. This can be achieved through clinical investigations or by leveraging existing clinical data. Develop a clinical evaluation plan (CEP) outlining the objectives, methodology, and endpoints of the evaluation.

Clinical Trials

For high-risk devices, conducting clinical trials is often necessary to gather robust clinical evidence. This involves:

• Study Design: Designing the clinical study to address specific clinical questions and regulatory requirements.
• Ethics Approval: Obtaining ethics committee approval for conducting the study.
• Participant Recruitment: Recruiting and enrolling participants in the study.
• Data Collection and Analysis: Collecting and analyzing clinical data to demonstrate safety and effectiveness.

Step 5: Manufacturing and Supply Chain

Manufacturing Process

Establish a manufacturing process that ensures consistent quality and compliance with regulatory standards. This involves selecting suitable manufacturing partners, validating production processes, and implementing quality control measures.

Supply Chain Management

Develop a robust supply chain management strategy to ensure the timely availability of raw materials, components, and finished products. This includes supplier selection, inventory management, and logistics planning.

Scaling Up

As you prepare for market launch, plan for scaling up production to meet anticipated demand. This involves optimizing production processes, increasing capacity, and maintaining quality standards.

Step 6: Marketing and Sales Strategy

Market Entry Strategy

Develop a comprehensive market entry strategy to introduce your medical device to the target market. This involves:

• Market Segmentation: Identifying and targeting specific market segments based on clinical need and device application.
• Pricing Strategy: Develop a pricing strategy that reflects the device’s value proposition and market conditions.
• Distribution Channels: Select appropriate distribution channels, such as direct sales, distributors, or partnerships with healthcare providers.

Branding and Promotion

Create a strong brand identity and promotional strategy to raise awareness and generate demand for your medical device. This includes:

• Branding: Developing a compelling brand story and visual identity.
• Digital Marketing: Leveraging digital marketing channels, such as social media, search engine optimization (SEO), and content marketing, to reach potential customers.
• Trade Shows and Conferences: Participating in industry events to showcase your device and network with key stakeholders.

Sales Team

Build a knowledgeable and effective sales team to promote and sell your medical device. Provide comprehensive training on the device’s features, benefits, and clinical applications. Equip your sales team with the necessary tools and resources to engage with healthcare professionals and decision-makers.

Step 7: Post-Market Surveillance and Support

Post-Market Surveillance

Implement a post-market surveillance plan to monitor the performance and safety of your device after it is launched. This involves:

• Data Collection: Collecting and analyzing post-market data, including adverse events, customer feedback, and performance metrics.
• Regulatory Reporting: Reporting adverse events and significant performance issues to regulatory authorities.
• Continuous Improvement: Using post-market data to drive continuous improvement and address any identified issues.

Customer Support

Provide robust customer support to address user inquiries, technical issues, and training needs. Establish a customer support team and develop resources such as user manuals, training videos, and online support portals.

Conclusion:

The journey from concept to market for medical device startups is complex and challenging but immensely rewarding. By understanding the key steps and regulatory requirements in the US and EU, startups can navigate this journey successfully. This comprehensive guide aims to equip startups with the knowledge and insights needed to develop, certify, and sell their medical devices effectively, ultimately contributing to advancements in healthcare and patient outcomes.

Helpful Sources

AI-driven Regulatory Affairs Assistant – Elly

Regulatory Service – Regulatory Intelligence Paper

EU Medical Device Regulation – EU MDR 2017/745

US Medical Device – FDA

Regulatory Globe Newsletter