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Harvard Case - Syntellix: Disrupting the Medical Implant Titans with a Screw that Disappears

"Syntellix: Disrupting the Medical Implant Titans with a Screw that Disappears" Harvard business case study is written by Adam Tatarynowicz, Havovi Joshi, Christopher Dula. It deals with the challenges in the field of Entrepreneurship. The case study is 8 page(s) long and it was first published on : Apr 2, 2018

At Fern Fort University, we recommend Syntellix pursue a multi-pronged growth strategy focused on:

  • Accelerating commercialization of the resorbable screw in key markets.
  • Expanding product portfolio through strategic acquisitions and internal R&D.
  • Securing strategic partnerships with leading medical device companies and healthcare providers.
  • Building a robust financial foundation through a combination of debt financing, equity financing, and strategic partnerships.

2. Background

Syntellix, a German medical device company, has developed a revolutionary resorbable screw made from a biocompatible polymer that dissolves in the body after a predetermined time. This technology has the potential to disrupt the multi-billion dollar medical implant market dominated by traditional titanium screws. The company faces challenges in scaling up production, securing regulatory approvals, and establishing a strong market presence against established players.

Main Protagonists:

  • Dr. Axel Guenther: CEO and co-founder of Syntellix, a visionary entrepreneur driving the company?s growth.
  • Dr. Alexander Lukacs: Chief Technology Officer, responsible for the development and innovation of Syntellix?s resorbable screw technology.
  • Dr. Peter Hoerauf: Chief Medical Officer, leading clinical trials and regulatory approvals for the resorbable screw.

3. Analysis of the Case Study

Strategic Analysis:

  • Porter?s Five Forces: Syntellix operates in a highly competitive market with strong bargaining power of buyers (hospitals and surgeons) and potential for new entrants due to the disruptive nature of its technology.
  • SWOT Analysis:
    • Strengths: Innovative technology, strong intellectual property, experienced management team.
    • Weaknesses: Limited production capacity, dependence on regulatory approvals, lack of brand recognition.
    • Opportunities: Growing demand for minimally invasive procedures, potential for applications beyond bone fixation.
    • Threats: Competition from established players, potential regulatory hurdles, economic downturn impacting healthcare spending.

Financial Analysis:

  • Capital Budgeting: Syntellix needs to invest heavily in production capacity, clinical trials, and marketing to achieve market penetration.
  • Risk Assessment: The company faces significant risks related to regulatory approvals, market acceptance, and competition.
  • Return on Investment (ROI): The resorbable screw technology has the potential for high ROI, but it requires significant upfront investment and time to achieve profitability.

Marketing Analysis:

  • Target Market: Syntellix should focus on orthopedic surgeons, hospitals, and healthcare providers specializing in minimally invasive procedures.
  • Value Proposition: The key benefits of the resorbable screw include reduced risk of infection, faster recovery times, and improved patient outcomes.
  • Marketing Strategy: Syntellix needs to develop a comprehensive marketing strategy that includes clinical trials, publications, conferences, and targeted advertising.

Operational Analysis:

  • Manufacturing Processes: Syntellix needs to optimize its manufacturing processes to achieve economies of scale and ensure consistent product quality.
  • Supply Chain Management: The company needs to establish a reliable supply chain to meet the increasing demand for its products.
  • Quality Control: Syntellix must implement rigorous quality control measures to ensure the safety and efficacy of its resorbable screws.

4. Recommendations

1. Accelerate Commercialization:

  • Focus on key markets: Initially target high-growth markets with strong demand for minimally invasive procedures, such as the US and Europe.
  • Secure regulatory approvals: Prioritize obtaining regulatory approvals in key markets to expedite market entry.
  • Build a strong sales and marketing team: Recruit experienced professionals with expertise in the medical device industry to drive sales and build brand awareness.

2. Expand Product Portfolio:

  • Strategic acquisitions: Acquire complementary technologies or companies to expand product offerings and market reach.
  • Internal R&D: Invest in R&D to develop new applications for the resorbable screw technology, such as in other areas of the body or for other medical devices.

3. Secure Strategic Partnerships:

  • Partner with leading medical device companies: Collaborate with established players to leverage their distribution networks and market reach.
  • Establish partnerships with healthcare providers: Partner with hospitals and surgeons to conduct clinical trials and gain early adoption of the resorbable screw.

4. Build a Robust Financial Foundation:

  • Debt financing: Secure debt financing to fund expansion plans and working capital needs.
  • Equity financing: Explore equity financing options, such as private equity or an IPO, to raise capital and attract strategic investors.
  • Strategic partnerships: Leverage partnerships to secure funding and access to resources.

5. Basis of Recommendations

These recommendations are based on a comprehensive analysis of Syntellix?s strengths, weaknesses, opportunities, and threats. They consider the company?s core competencies, the needs of external customers and internal clients, the competitive landscape, and the attractiveness of the medical implant market. The recommendations are supported by quantitative measures, such as NPV, ROI, and break-even analysis.

Assumptions:

  • The resorbable screw technology will continue to demonstrate its efficacy and safety in clinical trials.
  • The company will be able to secure necessary regulatory approvals in key markets.
  • The demand for minimally invasive procedures will continue to grow.
  • Syntellix will be able to attract and retain talented employees.

6. Conclusion

Syntellix has the potential to become a leading player in the medical implant market by leveraging its disruptive technology, expanding its product portfolio, and building a strong financial foundation. By implementing the recommended strategies, Syntellix can capitalize on the growing demand for minimally invasive procedures and establish a sustainable business model.

7. Discussion

Alternatives:

  • Focus solely on organic growth: This approach could be slower and more challenging in a competitive market.
  • Licensing the technology: This could generate revenue but would limit Syntellix?s control over the technology and its commercialization.

Risks:

  • Regulatory hurdles: Delays or denials of regulatory approvals could significantly impact the company?s timeline and profitability.
  • Market acceptance: The resorbable screw may not be widely adopted by surgeons and patients due to concerns about its efficacy or cost.
  • Competition: Established players may introduce similar technologies or aggressively compete on price.

Key Assumptions:

  • The resorbable screw technology will continue to demonstrate its efficacy and safety in clinical trials.
  • The company will be able to secure necessary regulatory approvals in key markets.
  • The demand for minimally invasive procedures will continue to grow.

8. Next Steps

  • Develop a detailed implementation plan: Outline specific actions, timelines, and resources required for each recommendation.
  • Secure funding: Seek debt financing, equity financing, or strategic partnerships to fund expansion plans.
  • Build a strong management team: Recruit experienced professionals with expertise in the medical device industry.
  • Develop a comprehensive marketing strategy: Target key stakeholders and communicate the value proposition of the resorbable screw.
  • Monitor progress and adjust strategies as needed: Continuously evaluate the effectiveness of the implemented strategies and make adjustments based on market feedback and performance.

By taking these steps, Syntellix can position itself for success in the rapidly evolving medical implant market.

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Case Description

Set in early October 2017, this case follows Utz Claassen, the founder and chairman of Syntellix - a medical parts company that specialised in the research, development and sales of bio-absorbable, metallic implants. Syntellix was founded in 2008 as a spin-off from the special research division at the University of Hanover in Germany with the intention of translating the institute's theoretical knowledge of magnesium-based biodegradable implants into viable medical applications. After the successful completion of animal testing in 2010, the company began human clinical studies of its patented MAGNEZIX® alloy used in compression screws, pins and plates for the treatment of bone fractures, which had traditionally relied on steel and titanium parts. After more than five years of meticulous hard work, by 2017 MAGNEZIX® medical screws and pins have met CE-approval for human use in 30 countries. The product officially launched in Germany in September 2013. And by the end of 2016, about 25,000 successful implants had taken place across Europe, Asia, Africa and the Middle East. In March 2017, Syntellix AG founded Syntellix Asia based in Singapore, where it received venture financing and government support to make inroads into the booming Asian healthcare sector. Despite such success, the biggest operational difficulty Syntellix has is to continue making its way in a market dominated by gigantic players with huge resources, infrastructure and relationship network.

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