As a Start-Up discovering and assessing the potential of your innovation, it is important that you are or become aware of the critical success factors and requirements to bring your MedTech innovation successfully to the market. Your Medical Device journey requires a multidisciplinary approach in which various inter-connected aspects need to be looked at. Critical choices have to be made as early as possible and have considerable implications on and how successful your company will become.
This is exactly where the strength of MD squared team comes in. Our team of content matter experts is able to help you to see through the complexity and inter-disciplinary dependencies and guide your start-up from the beginning through the different phases of growth
The four step approach to build your proposition
For Start-Ups we have developed a systematic approach, which helps you to understand exactly where you are in your journey to the MedTech market, and where your biggest gaps and your most important next steps are.
MD squared supports Start-Ups to make informed choices. This support usually starts with the execution of a QuickExam™, a fast and structured way to look at and evaluate the core of the proposition from different angles. The focus and activities during the QuickExam™ are tailored to the needs and specific questions of the client. A QuickExam™ typically has a 2 months throughput time.
Depending on the type of request for support, the following areas of expertise can be offered:
- Product: product definition, intended use and classification
- Clinical data: Clinical Evaluation, Clinical Data collection and Post-Market Clinical Follow-Up
- Regulatory: Regulatory requirements and applicable standards (MDR/IVDR, FDA and SFDA)
- Quality: Risk based Quality Management System according ISO13485:2016
- Technology Development & Manufacturing: Technical Documentation, Adequate Product Design and Validation
- Market: Addressable market and barriers, Standard of Care and treatment alternatives
- Business Strategy: viability of business case
It is important that all areas line up equally during development of the company and any gaps are timely identified and filled in. For each segment, the level of maturity is defined, showing the gap to reach compliance with the requirements and identify the necessary steps to reach the next milestone(s).
Targeted Venture Support
Based on the outcome of the QuickExam™ and the needs of the Start-Up, MD squared is able to offer Venture Support. Venture Support is designed and targeted to support and guide the Start-Up towards Market Acces and Market Acceptance.
In the first phase of targeted venture support, experts of MD squared support the Start-Up in updating the business plan, developing scenarios/options and recommendations on prioritization, detailing subsequent steps, deliverables and planning to reach the next level of maturity. All activities need to be coordinated and aligned to prepare for a successful market access. Coaching of team members by seasoned experts of MD squared happens automatically during this phase.
The final phase of support is towards market acceptance, building the company. Content matter experts of MD squared can support in daily activities in agreed areas of interest or can be involved on an ad-hoc basis in strategic and/or operational decision phases.
Key reasons for failure
Too much focus on Technology
Usually, Start-Ups focus on technical development of a product or application first, but clinical development as well as customer and market development are certain stumbling blocks if not taken care off properly. Applying an integral approach from the start is important and desired.
Regulatory compliance too difficult
With the introduction of the Medical Device Regulation (MDR) in Europe, it becomes even more challenging for Start-Ups to meet all requirements for a new product or application, and at the same time maintain your competitive edge and the viability of your business case.
No differentiating product
Having a differentiating product is key for the existence and growth of a Start-Up. It is an absolute must. Becoming successful with a new product in an existing market is not obvious. A new product needs to provide unique features and demonstrate superior performance compared to existing products.
Business model does not match market demand
Getting a clear view on the viability of the business model for a new propositon is crucial. Applying and filling in a business model canvas will raise the right questions that need to be answered. There needs to be a clear market demand for the new product, otherwise it will be difficult to get traction in the market.
Liquidity problems & investment needed
Having a sound cash position is key for continuity of the Start-Up. Because of the amount of uncertainties and risks, many times companies run out of cash too quickly and need to spend significant efforts in finding new investors while at the same time they should be working on developing the product and mitigation the risks.