Skip to main content
QMSQMS
QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
    • GP-001 Documents and records control
    • GP-002 Quality planning
      • Deprecated
      • R-002-001 Quality objectives list_2024_001
      • R-002-001 Quality objectives list_2025
      • R-002-002 Quality objectives_2024_001
      • R-002-002 Quality objectives_2024_002
      • R-002-002 Quality objectives_2024_003
      • R-002-002 Quality objectives_2024_004
      • R-002-002 Quality objectives_2024_005
      • R-002-002 Quality objectives_2025_001
      • R-002-002 Quality objectives_2025_002
      • R-002-002 Quality objectives_2025_003
      • R-002-002 Quality objectives_2025_004
      • R-002-002 Quality objectives_2025_005
      • R-002-003 Quality indicators_2024
      • R-002-004 Annual management review report
      • R-002-005 Quality Calendar_2025
      • R-002-006 SWOT and CAME analysis
      • R-002-007
      • R-002-008 Quality and regulatory roadmap
      • R-002-009 Regulatory requirements review report
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 HR and training
    • GP-007 Post-market surveillance
    • GP-009 Sales
    • GP-010 Suppliers
    • GP-012 Design, Redesign and Development
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation
    • GP-023 Change control management
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-011 Provision of service
    • GP-110 Esquema Nacional de Seguridad
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Grants
  • Pricing
  • Public tenders
  • Records
  • GP-002 Quality planning
  • R-002-006 SWOT and CAME analysis

R-002-006 SWOT and CAME analysis

Definitions​

SWOT

SWOT analysis is a framework for identifying and analyzing an organization's strengths, weaknesses, opportunities and threats.

CAME

CAME (Correct; Address; Maintain; Explore) is the tool that will help us put into practice what was obtained in the SWOT analysis. We are going to correct weaknesses, to address threats, to maintain the strengths and finally we are going to explore the opportunities.

Threats

External risks that we do not have direct control over.

SWOT analysis​

Weakness
  • W1. The company is very young.
  • W2. Low awareness of potential customers in key segments in international markets about the company's existence.
  • W3. Immature strategy for implementing pilots in care providers.
  • W4. Insufficient marketing materials to effectively engage at various sales funnel stages, particularly:
    • W4.1. At the post-sales phase.
  • W8. Few people leading many areas and tasks.
  • W9. Reduced team to cover all developments and constant newly generated market demand.
  • W10. Limited track records in the clinical trials segment.
  • W11. Price points for each segment not thoroughly validated.
Threats
  • T1. The market is saturated with competing companies that have greater positioning and longer trajectories, presenting a significant hurdle.
  • T2. The possibility that competitors could replicate our value proposition necessitates swift action to capture market share before they do.
  • T3. The risk of facing penalties due to regulatory limits on product claims underscores the importance of careful compliance.
  • T4. Delays in achieving necessary certifications could hinder the commercialization timeline
    • T4.1 ISO/IEC 27001
    • T4.2 Regulatory certification such as MDR in Europe
  • T5. The threat of being copied by larger companies with more resources, particularly in the pharmaceutical sector, looms large.
  • T6. A general lack of understanding and interest in regulatory aspects by clients regarding new solutions could slow market adoption.
  • T7. Insufficient clinical evidence to back up product claims could critically impact market trust and acceptance.
  • T9. Diverse regulatory requirements across international markets pose significant barriers to entry
    • T9.1 USA
    • T9.2 Brazil
    • T9.3 Mexico
    • T9.4 Japan
    • T9.5 Saudi Arabia
  • T10. The new AI Act could delay product launches and increase the complexity and costs of product development.
Strengths
  • S1. The product has been co-developed and validated in collaboration with specialists and end users, ensuring it meets genuine needs.
  • S2. The leadership team possesses in-depth knowledge of the competitive landscape and has strategically positioned the company to stand out.
  • S3. The company offers a distinct and validated value proposition that sets it apart in the marketplace.
  • S4. The technology for tracking diseases or classifying their severity is groundbreaking, establishing the company as a pioneer and leader in this technological domain.
  • S5. Unlike its competitors, who focus on patient-centric solutions, the company prioritizes both patients and physicians, offering a more holistic approach.
  • S6. The competition primarily focuses on diagnosis without considering the severity of conditions, whereas the company emphasizes both aspects, providing a more comprehensive solution.
  • S7. The founder team boasts extensive market knowledge, understanding the intricate needs and challenges within their sector.
  • S8. The team includes a prominent expert in technology development, leading its team to innovative breakthroughs.
  • S9. The company is committed to documenting knowledge and automating numerous processes, which enhances learning, compliance and accelerates progress.
  • S10. The company emphasizes the creation and documentation of best practices, aiming to refine work processes across all departments for continuous improvement and compliance.
  • S11. The company counts with an experienced sales leadership with thorough knowledge of the healthcare market and the company’s target segments.
  • S12. The company has established itself in Spain as one of the most prominent and appealing players in its sector and is actively expanding into other markets.
  • S13. The company has secured significant partnership agreements with leading pharmaceutical companies in the sector, which can help expand the product into various markets.
Opportunities
  • O1. There is a notable lack of specialists to meet the growing demand for healthcare, creating a gap in necessary medical services.
  • O2. Dermatologists tend to focus more on aesthetic procedures than on fundamental medical care, worsening accessibility to appropriate healthcare.
  • O3. The increasing incidence of skin diseases urgently requires innovative digital solutions.
  • O4. The constant growth in market needs and issues opens broad growth opportunities for the company.
  • O5. In response to the trend of focusing on aesthetic treatments, there emerges a demand for comprehensive solutions that allow non-specialist professionals to meet the growing medical need.
  • O6. Digital transformation and automation become essential to improve the efficiency of healthcare providers.
  • O7. Minimizing errors in medical referrals is established as a critical goal to optimize healthcare.
  • O8. Encouraging greater adherence to treatment by patients is fundamental for the success of health outcomes.
  • O9. Value-oriented medicine supported by solid data is presented as a pressing need in the sector.
  • O10. Pharmaceutical companies face the challenge of accelerating their development processes to respond to market demand with a very clear need, to be the first to launch their product to the market, therefore, they bet on solutions that allow them to make this possible.
  • O11. Pharmaceutical companies seek to sponsor digital solutions in the medical sector to promote their brand and products.
  • O12. There is a shortage of scientific publications in dermatology and artificial intelligence that drive innovation in the area.
  • O13. Public health systems in Spain started to launch public tenders to procure digital solutions for dermatology.
  • O14. Growing demand for innovative healthcare solutions in international markets, such as Nordics and Asian countries.
  • O15. Showcasing the company’s solutions at industry summits and trade shows increases brand visibility and generates high-quality leads.
  • O16. Increased focus on teledermatology creates an opportunity to position the company’s solution as essential for remote healthcare delivery.

CAME analysis​

Correct
  • C1. Implement mechanisms for regular customer feedback to improve business development operations.
  • C2. Leverage SEO and a targeted content strategy to enhance the company's online visibility, including multilingual content to reach diverse markets.
  • C3. Create a diverse range of marketing materials tailored to various stages of the sales funnel, supporting both lead generation and sales conversion processes.
  • C4. Collaborate with early adopters to document and develop use cases, showcasing the product's application and advantages to facilitate better customer understanding and sales negotiations.
  • C5. Refine the company's strategy to enhance its presence in the industry, utilizing a multi-channel approach including digital marketing, PR campaigns, and active participation in industry events for increased brand visibility and recognition.
  • C6. Recruit people with more experience to independently lead departments and implement leadership development programs, reducing the strain on key personnel and improving departmental management.
  • C7. Conduct regular training and market analysis sessions for key decision-makers to ensure they fully understand the company's value proposition and competitive advantages.
  • C9. Explore new funding avenues to ensure sufficient financial resources are available for business development and large-scale projects, aiming to meet market demand and stay ahead of competitors.
  • C10. Improve sales team expertise and capacity by providing coaching and mentoring for continuous improvement.
Address
  • A1. Continuously innovate and differentiate product offerings to stand out in a saturated market, focusing on unique features or services.
  • A2. Rapidly develop and launch new features or products to capture market share and implement IP protection strategies to safeguard unique value propositions.
  • A3. Enhance compliance measures by staying updated with regulatory changes, conducting regular audits, and training staff on compliance requirements.
  • A4. Allocate dedicated resources to expedite the process of obtaining critical certifications, engaging with certification bodies early.
    • A4.1 Obtain ISO 27001 certification
    • A4.2 Obtain MDR certification
  • A5. Develop a strategic legal approach to protect against copying by larger entities, including proactive intellectual property registration.
  • A6. Provide comprehensive educational materials and workshops for clients about the regulatory aspects of new solutions to increase understanding.
  • A7. Invest in clinical studies to generate robust evidence supporting product claims, partnering with reputable institutions.
  • A8. Develop specific regulatory and market entry strategies for each target international market:
    • A8.1 Obtain FDA approval in USA
    • A8.2 Obtain ANVISA approval in Brazil
    • A8.3 Obtain COFEPRIS approval in Mexico
    • A8.4 Obtain regulatory approval in Japan
    • A8.5 Obtain SFDA approval in Saudi Arabia
  • A9. Strengthen market awareness and demand generation efforts by engaging in outbound sales activities and participating in industry conferences, congresses and trade shows.
Maintain
  • M1. Enhance key partnerships with customers, suppliers, medical and patient associations, and seek new alliances with prestigious universities, governmental institutions to co-create value-added services, leverage collaborative innovation, and enhance research, development capabilities and brand positioning.
  • M2. Keep abreast of market changes and competitor movements with a proactive and strategic approach.
  • M3. Utilize the vast amount of data collected of the company operations for strategic insights to inform product development and marketing strategies.
  • M4. Develop new functionalities incorporating AI and machine learning for more sophisticated automations in proposing interventions, ensuring the platform remains adaptable and ahead of market needs.
  • M5. Develop a strategic communication plan that highlights the company’s strengths, innovations, and value proposition, leveraging social media, professional networks, and industry events to enhance brand visibility and thought leadership.
  • M6. Foster a customer-centric sales culture to strengthen long-term relationships and market presence, by continuing regular engagement with existing clients to identify new needs and upsell opportunities.
  • M7. Continue with ongoing training and technology watch, focusing on emerging technologies and trends in disease tracking and severity classification, while investing in specialized training for the team to maintain technological leadership.
  • M8. Prioritize good practices, know-how documentation, and process automation, integrating feedback loops from all stakeholders into documentation and process improvement for continuous operational improvement.
  • M9. Encourage a company-wide culture that values innovation, collaboration, and continuous learning.
  • M10. Maintain a diverse sales team with members specialised in specific phases of the sales process and specialised in specific customer segments.
  • M11. Maintain the strategic partnerships with key pharmaceutical companies established during the year.
  • M12. Participate in scientific research and contribute to publications in dermatology and AI fields to solidify the brand's authority.
Explore
  • E1. Establish partnerships with leading healthcare institutions to introduce alternative care solutions addressing dermatology specialists shortage.
  • E2. Given the trend of dermatology specialists focusing on aesthetic treatments, develop comprehensive solutions that empower non-specialist professionals to meet the growing medical demand.
  • E3. Launch comprehensive training programs for non-specialist professionals, enabling them to deliver medical care effectively.
  • E4. Commit to research and development to create innovative, tailored solutions for various skin conditions.
  • E5. Enhance digital platforms with advanced automation, digitalization, and remote care features.
  • E6. Develop and perfect intelligent referral systems to minimize errors and improve patient navigation in the healthcare system.
  • E7. Implement strategies to improve patient adherence to treatments, enhancing health outcomes.
  • E8. Introduce tools for collecting, analyzing, and interpreting real-world data, bolstering evidence-based and value-based healthcare practices.
  • E9. Forge stronger partnerships with pharmaceutical firms to facilitate the use of digital solutions in clinical trials and hospital endorsements.
  • E10. Formulate marketing and outreach strategies that highlight the advantages of healthcare digitalization.
  • E11. Promote the integration of new technologies in healthcare through informative webinars and live demonstrations.
  • E12. Perform market analysis to pinpoint under-saturated markets ripe for strategic entry.
  • E13. Investigate emerging markets for viable investment opportunities, with an eye on long-term viability.
  • E14. Assess the potential for extending the product range into new areas and specialties, like allergy.
  • E15. Participate in scientific research and contribute to publications in dermatology and AI fields to solidify the brand's authority.
  • E16. Expand sales strategies to capture new market segments and unexplored territories to identify untapped markets.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: JD-004
  • Reviewer: JD-001
  • Approver: JD-001
Previous
R-002-005 Quality Calendar_2025
Next
R-002-007 Process validation card 2023_001
  • Definitions
  • SWOT analysis
  • CAME analysis
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)