MedTech is a very challenging sector, with regulations so tough and expensive that innovation is made almost impossible
as product prices accepted are low compared to ever increasing development regulatory and purchasing complexity, cost, and investments in healthcare. A tragic combination that leaves many low-risk healthcare Quality of Life projects undone.
In the CBO-Initiative we manage entire projects within our coordinated and experienced teams, in close alignment with the Technology Owner. We screen for Grand Ideas with stakeholders, manage all functions of the Go-To-Market process, and have an establish network of distributors and MedTech investors. Our focus is on concept preparation and execution.
You can choose to engage with us for individual functions or the full concept.
*) Note: Various statistics confirm that about 95% of MedTech and Pharma start-ups fail. In Denmark, 95% of MedTech and Pharma startups were discontinued when measured as a 10, 20 or 30-year average from company register (CVR-data). But only until the Coronavirus hit us as state funding program during the Corona pandemic kept many companies alive. You can discuss what success is, but only 2% made it to a level of more than 100 employees.*
A natural CBO organizational structure for cooperation with us could be the one outlined below, but variations are welcome and depend entirely on the functions a potential partner would like to contract for.
Potential structure
The CBO Initiative is a coordinated team effort to reduce burn-rate.
CONTRACT BUSINESS ORGANISATION
Product Development & Prototypes
• The ability to Develop concepts, prototypes, and Products for Manufacture (CDO)
Clinical Affairs & Reimbursement
• To liaise with and potentially manage the clinical studies
Regulatory Affairs
• To handle MDR/FDA approval and all Regulatory Assurance processes (RA)
Manufacturing & Quality Assurance
• To Manufacture finished goods (CMO)
• To offer Quality Assurance and necessary ISO and GMP certificates (QA)
Legal & Intellectual Property Rights
• To support legal and Intellectual Property Rights with a focus on process patents (IPR)
• To liaise with Distributors during the development process and negotiated Sales contracts.
Product Launch & Market Penetration
• To involve and potentially negotiate Commercial contracts with distributors (CCO)
• Potentially manage the supply chain
INNOVATORS IDEAS - Technology Owners
Only Grand Ideas make it, Grand enough for that single idea to carry the cost of an entire business organization. We offer a screening process with Voice of Distributors to identify the best options.
The CBO concept allows the Technology Owner to avoid having to build and invest in a new and inexperienced organization by offering to be the Legal Manufacturer. This will reduce the cost, the risk of expensive failures, and consequently the burn-rate.
INVESTORS CAPITAL – Shareholders
By having an international MedTech investor network who believes in the screening processes and
CBO concept – offering them risk mitigation.
REDUCING RISK
As 95% of MedTech startups stumble*, there is an obvious need to reduce risk!
The development process right to launch and market penetration is complex, involving a variety of functions that must not fail – if the burn-rate is to be kept under
control. Mistakes can cost years of burn-rate. In Medtech success comes with penetrating the market and showing proof of sales at a reasonable level, therefore
success requires a complete organization.
Product Development (CDO)
Working with an experienced team reduces risk, as:
• Understanding the need through “Voice of Customer” processes is only partly introduced in the concept development, as it is often translated to “Voice of User”, not involving Voice of Distributor or Sick Fund (the paying customer), leading to restricted sales routes and no reimbursement. Products risks not to fulfill the needs of the payer.
Marketers are often involved too late in Value Proposition and concept discussions.
• Concept development never finishes, designs are not frozen, and clinical work is done on an early-stage product, leading to expensive re-work and loss of time.
• Product development, prototyping, and Value Proposition discussions take place in all phases right to the launch, leading to slow expensive processes, poor outcomes, and a sub-optimal clinical study and consequently product at launch.
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Regulatory Assurance (RA)
Working with an experienced team reduces risk, as:
• RA exhausts any inexperienced organization – and years are normally lost. These complex QA systems can only wisely be built by companies already in the game and are often one important cause of unnecessary high burn-rate as years are lost.
• A CMO already has the QA systems Regulatory Assurance is based on but requires a decision on who is the Legal Manufacturer – not the Technology Owner.
If you are interested in the CBO Initiative – click here
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Manufacturing and Quality Assurance (CMO)
• Manufacturing is a complex process and rework from design for prototypes, to Design for Manufacturing, pilot and scale-up is expensive – mistakes are costly.
• Quality Assurance starts with the design freeze (moving target) and detailed Standard Operation Procedures (SOPs) need to be described and built into a certified Quality System (EN13485/GMP). Only an experienced CMO can do that efficiently, having control over the production site.
• A CDMO team is required to reduce time and costs.
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Legal & Intellectual Property (IPR)
You have only 20 years of patent protection
• Product IP is often unnecessarily diluted by years of delays,
• Process-IP is less in focus.
• Contract negotiations along the entire value chain are not done by MedTech specialists, who know the critical business segment elements.
If you are interested in the CBO Initiative – click here
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Clinical Studies & Reimbursement
• Technology and product ownership obviously lies with the Inventor organization, therefore Clinical studies and Reimbursement Assurance is part of their responsibility – it is the PRODUCT. However, the CBO can help and, in some cases, manage the studies, as they have to be aligned with the Design specifications and Value Propositions aimed for.
• Reimbursement is a national matter and in the EU we have 27 countries and 24 different languages. The US is easier. The price reality check comes into play too late (lack of distributor contact), which risks undermining the often-overoptimistic price setting and business cases.
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Launch & Market Penetration
• Investors often think the job is done when a CE mark is obtained – but it is only half the MedTech journey – through the valley of death.
• Prevalence data are often used to estimate market opportunities, painting an unrealistic optimistic picture, and neglecting the competitor displacement struggle that lies ahead. often think the job is done when a CE mark is obtained – but it is only half the MedTech journey – through the valley of death.
If you are interested in the CBO Initiative – click here
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