References

Projects we managed in the past

ACTIONS SPEAK LOUDER THAN WORDS

In the past, we have already realized many challenging projects – both with established companies and with ambitious start-ups. In doing so, we have also worked together with investors and developed high-yield concepts.

In our many years of work, we have been active for many companies in a wide variety of functions and projects.

Our work for medical device companies

Projects

Medical technology is our home. Below you will find an overview of some of our implemented projects with established medical device companies.

Project management development of a class IIb/ III product

The company: Berlin Heart GmbH – an internationally active medical technology company in the field of mechanical cardiac support.

The task: Project management for the development of a class IIb/ III medical device, intended for worldwide approval.

Our Activity: We restructured the project and took over the multi-year project management with about 70 internal and external project members.

Customer benefit: The client was able to rely on our many years of experience in product development in collaboration with external partners and our professional management expertise, and benefited from a sustainable internal know-how build-up.

Specifically, this was achieved:

  1. Successful completion of product development
  2. Compliance with the development budget
  3. Manufacturing transfer incl. manufacturing, maintenance and logistics contract
  4. Life Cycle Management
  5. Completion of approval documents for CE & FDA
Product portfolio recertification and MDR gap analysis

The company: Internationally active medical technology company with resorbable bone substitute materials.

The task: Planning and execution of the recertification of the product portfolio according to the European Directive as well as gap analysis regarding MDR requirements.

Our activity: We reviewed the technical documentation for the Class III product portfolio and created a new design dossier as part of the recertification. The new MDR requirements and requirements from technical standards were defined and implemented in consultation with the Notified Body.

The customer benefit: Our client’s product portfolio was recertified on time and within budget. New regulated requirements were reviewed and comprehensive remediation measures were initiated to further improve the documentation of the established product portfolio.

MDR analysis and technical documentation update

The company: Various medical device manufacturers.

The task: Reviewing the quality of technical documentation, gap analysis and remediation of deficiencies if necessary.

Our activity: we analyzed the scope and quality of technical documentation and initiated remediation programs. This included:

  • Review and documentation of technical standards
  • Scope and quality of verification and validation tests
  • Creation of design history files
  • Evaluation of clinical data, equivalence considerations and PMCF measures
  • Review of risk analyses and integrated risk management
  • Post-market surveillance, complaint and reporting processes
  • Re-creation of technical documentation and design dossiers.

Customer benefits: Together with the manufacturers, we improved the status of the technical documentation by updating individual chapters through to a complete redesign. The company’s own resources were relieved and a sustainable build-up of know-how was achieved.

Process development for CE marking and product registration

The company: Internationally active medical technology company in the field of orthopedic implants and instruments.

The task: Review and set-up of processes for CE marking and product registration of medical devices.

Our activity: We evaluated the status quo of processes for CE marking and product registration of Class I, IIa, and IIb medical devices and implemented additional processes to ensure that regulatory requirements for conformity assessment of both national and international registrations are met. This involved optimizing Regulatory Affairs’ interfaces with other departments and taking steps to integrate the new processes and structures into the company’s quality management system.

Customer benefits: Targeted measures created structures and processes that enabled our customer to optimize its internal processes for CE marking and improve communication with Notified Bodies and national registration authorities. The sustainability of our measures was confirmed in audits.

Consideration of an investment in a medical start-up

The company: Internationally active plastics manufacturer.

The task: Examination of a possible investment in a medical technology start-up.

Our activity: we analyzed the know-how of the start-up team as well as the technical risks of the class III product to be developed for cardiac interventions and compared them with the product portfolio and the strategic orientation of the manufacturer.

Customer value: Together with the manufacturer, we developed a strategy as well as concrete measures to minimize the risks of the project. By estimating the development effort and costs as well as the market opportunities, we provided our client with a decision-making basis for this investment.

Buy-out for a diagnostic system

The Company: Leading global medical technology company

The task: A concept for a buy-out of a diagnostic system for intensive care units was to be prepared.

Our activity: We performed the technical and economic review of the concept and the implementation plan including the risk analysis.

Client benefits: The client understood the market requirements and hurdles of market entry. He was able to rank the value of his USP in this market. A marketing plan and a profitability analysis gave him the information for his business decision.

Technical evaluation of an immunological method

The Company: World leading company in the field of dialysis.

The task: The technical evaluation of an immunological method and the applicability for the customer was to be carried out.

Our Activity: We conducted interviews with the vendor, analysis of the technical documentation, markets, and existing products, and evaluated the feasibility options, providing an independent assessment of the feasibility and chances of success of this project.

Client Benefits: The customer received a comprehensive understanding of the technology, the IP situation, and the implementation risks. This formed the basis for the decision to start a development project.

Our work for startups

Projects

Below you will find an overview of some of our implemented projects with innovative start-ups.

Preparation of a business plan and search for investors

The company: Start-up with innovative inhalation technology.

The task: The company founder approached us to evaluate his business idea. Furthermore, 3R LifeScience was to review the business plan and assist in the search for suitable investors.

Our activity: Together with the founder, we tested the technology for feasibility up to the functional model, worked out possible application potentials and business areas, and optimized the business plan. This was presented to several potential investors and strategic partners.

Client benefit: The start-up was co-financed and continues to develop its technology for mobile inhalers.

Strategic further development of a start-up company

The Company: A successful start-up company in the field of drug delivery.

The task: The start-up is evolving into a new phase. Processes, management tools, and structures were no longer adapted to the new phase. This led to significant internal conflicts.

Our activity: Target processes and an effective reporting and review system were introduced. Intensive conflict and change management accompanied this process.

Customer benefits: The management was relieved by the new tools and could concentrate on product and company development again. The working atmosphere was significantly improved.

Operational interim management for medical technology certification

The Company: A start-up company with innovative product developments in ophthalmology.

The task: The medical device certification had to be prepared.

Our activity: We structured the polymer selection for the product according to functional and regulatory aspects. We developed certification strategies for the development product, defined product requirements, and prepared an expert opinion on the certifiability of the development product, as well as performed comprehensive business and project risk analyses.

Client benefits: Our work was the basis for creating the business plan and the next strategic and operational milestones. Through our professional support during the presentations and in negotiations with potential investors, further financing was achieved.

Financing and restructuring of a start-up company

The Company: A German start-up company developing innovative synthetic materials.

The task: The task was to find an equity investor for the financing of the medical device development.

Our activity: We searched worldwide for suitable investors, prepared the company presentation, performed the due diligence, and supported the negotiations with the investors. After financing, we led the restructuring of the company and designed a development portfolio.

Client benefits: The start-up was funded and is now valued in the double-digit million (euro) range. The company was able to focus on the development of high-value medical technology products.

Our work for investors

Projects

The following is an overview of some of the projects we have implemented for investors in medical device companies.

Support for the financing decision of a European venture capital group

The Company: A European venture capital group

The task: An independent evaluation of an endoscope technology manufactured by a company in southern Germany was commissioned. It was to assist the VC group in making a decision for follow-on financing.

Our activity: We talked to the company management and scientists to understand the status of the development, the remaining risks and the technical implementation potential. Analysis of the production process with the endoscope manufacturer clarified the planned and potential cost savings.

Customer benefits: Our analysis results encouraged the VC group to finance the company with 4.5 million Euros in September 2008.

The result of our successful cooperation with invendo medical’s investors can also be read in the press release.

Due diligence of a dialysis system

The Company: An international venture capital group

The task: to perform technical due diligence on a novel dialysis system to support a multi-million dollar investment.

What we did: We interviewed the company’s management and developers, analyzed and evaluated technical documentation and literature, interviewed competitors and users, and assessed potential key suppliers.

Client benefits: This gave investors an understanding of the remaining development and go-to-market risks. They were able to make their investment decision as well as take corrective action on the development focus

Financing, restructuring and further development of a start-up company

The Company: A German start-up company developing innovative synthetic materials.

The task: The task was to find an equity investor for the financing of the medical device development.

Our activity: We searched worldwide for suitable investors, prepared the company presentation, performed the due diligence, and supported the negotiations with the investors. After financing, we led the restructuring of the company and designed a development portfolio.

Client benefits: The start-up was funded and is now valued in the double-digit million (euro) range. The company was able to focus on the development of high-value medical technology products.

These companies ensured their successful future in the MedTech world through our cooperation:

Pulsion Logo
Berlin Heart Logo
Life Systems Logo
Getinge Logo

– Case Study –

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