Transforming to the biggest change in healthcare since decades is essential to stay competitive. Value based care introduces analysis and data as the most important unique selling propositions.
Navigating complex development projects through various stages from early research to production requires a broad knowledge and experience, specifically when working with external R&D and manufacturing resources.
Market access in the US and Europe is closely linked to regulatory approval frameworks set by the FDA and the European commission. We support you to plan the best path to market in early stages of your development.
Time series analysis, Statistics, Big Data in real world environments, requiring artifact robust methods. And even more important: How to interpret results in a clinical context?
We are coaching Start-ups, get engaged in interim management positions and board positions to actively help launching the rocket in the right direction.
Most promising new products and methods are invented in Universities and Research Institutions. Getting involved early saves you a pole position.
New Business Models
With the change to value based care the business models change to service based and personalized approaches. You want to explore how your business can evolve and change?
Today, medical devices focus on function and quality. Design and the emotional side of the products are secondary. With the move to the digital era and the merge of Consumer with Medical this is quickly changing. Don’t miss the opportunity!
Smartphones are an enabling technology that allows to bring diagnosis and monitoring to the masses. Combining low cost sensors with Smartphone applications opens new business opportunities. How can you participate?
A broad and knowledgeable overview and the resulting realistic evaluation and control of all decisive elements are the basis for goal-oriented innovation when introducing a new product or business sector.
We assist in solving questions involving all aspects of innovations, new products and the development of new areas and markets in the Life Sciences, especially in the medical technology sector.
This includes providing advisory opinions, reports, research and education, participation in individual discussions or planning processes, up to complete project control and interim management.
Our focus lies on the Life Science markets that are still by far the most important: Europe and the USA. Almost 70% of all Life-science revenue is generated in European countries and the United States.
Profit from a proven, extensive network of competent and strong partners!
Dr. Michael Lauk
Good consultation performance lives solely from those who do it.
Interdisciplinary activities characterize my personal background right from the start of my education. As a matter of course, I work cooperatively and in teams with the most diverse specialists and disciplines to find the optimal solution.
The real value of all the Tera-bytes of data we gather in life sciences is still hidden: the interpretation in a clinical context.
Experienced serial start-up entrepreneur and manager in the healthcare field, focused on technology, products, and services in life science, healthcare and medical devices, especially in Pulmonary medicine, Sleep, and Neurology.
I am focused to homecare and consumer healthcare. With a rare combination of knowledge in data analysis, statistics, and IT on the one side and traditional medical device design on the other side I am perfectly positioned to enter the new fields of Medical Apps, mobile health, and digital health.
Within 16 years of experience in start-up companies, 9 of them in a medical device contract R&D and manufacturing company, I enjoyed working with dozens of new technologies, services, and products in every aspect. From research, engineering, regulatory, and manufacturing up to the build of a sales force.
Dr. Lauk Management Consultants 2009 – Today
- Support in the planning of a R&D project with cost and time estimation, evaluation of R&D projects, outsourcing in R&D, identification of risks and alternatives, questions of production transfer.
- Support clients in the transformation to the Transform Digital health and Mobile health era.
- Technology transfer: creation of possible licensing scenarios, negotiations with licensors or licensees, successful implementation of transfer projects.
- Support of foreign companies for market launches in the healthcare markets of Europe, especially in Germany.
- Strategic FDA and European regulatory consulting.
- Strategies for investor search and coaching of start-ups.
CTO, Co-Founder, inSleep Technologies 2009 – Today Weston, FL
Our breakthrough therapy device will be on the market soon. We’ve applied high-tech design common in today’s most appealing smart devices and brought sophistication and high styling to our devices treating sleep disordered breathing.
Founder StudyMyHealth 2011 – Today
The StudyMyHealth suite allows users to track their health data simply through their iPhone, either for their own purposes or to share with their doctors.
For more information please visit StudyMyHealth.com
CEO, Founder TNI medical AG 2007 – 2009 Freiburg (Germany), Baltimore
Design, manufacturing and introduction of a new therapy and a new trademark in the medical device home-care market.
CEO, Founder seleon GmbH 1998 – 2007 Freiburg, Dessau (Germany)
- Responsibility for and execution of more than 50 development and manufacturing projects of diverse sizes for customers from medium-sized businesses to large-scale industries, primarily in the Life Sciences sector.
- Formation of the company in 9 years from the ground up, from nothing to over 100 employees.
- Extensive experience with patents, licenses and trademarks.
- Several successfully completed structural adjustments (merger and also corporation splitting).
- Creation of reliable dynamic models for fiscal planning and control in rapidly growing companies.