Ashmita Das, CEO of Kolabtree12.16.21
The medical device industry is no stranger to outsourcing. In the UK, U.S. and EU around 20,000 medical device organizations outsource $99 billion worth of work annually, of which $9 billion is related to regulatory and product development services. This article explores how the outsourcing model is changing for medical device companies.
According to PwC, the healthcare industry is set to become the largest spending sector on research and development (R&D) globally. Much of this comes from large players, who have both hefty teams in-house for everything from research to regulatory writing, and deep pockets for financing their product launches. The same is cannot always be said for start-ups and small and medium enterprises (SMEs), who must compete in a challenging environment.
However, the success of these smaller medical device businesses is vital. According to Eurostat, 14.3 per cent of all medical technology patents in Europe came from SMEs, and the medical device sector is one of the top five industries in Europe that benefits from the innovation of smaller businesses. To bring products to market and launch successfully, small medical device businesses therefore have difficult decisions to make on how best to allocate resources.
A difficult decision all medical device businesses must make when bringing products to market is how best to build their team. Recruitment can be a tricky thing to manage in an industry where demand is periodical — full-time staff may not always be a feasible option. Looking at jobs posted on Glassdoor, the average medical device consultant salary is around $60,000 per year.
Outsourcing can also help medical device organizations to be better equipped to face regulatory changes, such as the recent update to the EU Medical Device Regulations (MDR). As global regulations tighten, the new framework increases the demand for clinical evidence, reporting and clinical trial management. Consequently, medical device companies are outsourcing bigger chunks of their research and regulatory work to specialists.
To meet the needs of medical device manufacturing businesses, the contract research organization (CRO) pool stands strong. Medical device companies can outsource almost all parts of the process to CROs, from design, to manufacture, to packaging, to testing.
However, contracting a CRO doesn’t necessarily bridge all of a medical device company’s skills gap. There are different types of CRO available, varying in specialism. Many of them also do not have all the required skills in-house, especially for highly specialized projects. This means that CROs often consult third-party specialists or scientific freelancers to bolster the services they offer clients.
In this instance, medical device companies may be paying a premium to access skills through a CRO middleman that they could have targeted directly — an external consultant can cost up to $20,000 a week. It is always worth researching CROs in detail, as well as asking them for their credentials and case history of working in the specific niche, before committing to their services.
Working with multiple partners introduces several challenges. Firstly, a member of the medical device team, or multiple people, will have to co-ordinate agency and expert management, including service delivery, payments and compliance. Secondly, a wide pool of consultants can introduce intellectual property (IP) and confidentiality challenges, particularly as many small businesses do not have their own in-house patent attorneys.
A freelance medical device consultant can be a real benefit to SMEs and start-ups, offering highly specialized expertise quickly, even within 24 hours, without the medical device company committing to a long-term hire or partnership. On many platforms, the freelancer quotes upfront and the medical device company only pays for the work completed, with no extra retainer fees or minimum order values. This model provides access to high-quality talent, but in a more effective way than working with agencies — data from Kolabtree shows that hiring a freelance consultant can save up to 40 per cent.
Working with freelancers means manufacturers can access heavy regulatory support, as and when needed to achieve device certification or maintain annual documentation. For example, a manufacturer seeking to market their product in the EU could hire an experienced freelance clinical evaluation report (CER) writer, with prior experience of the legislation.
The same can be true of clinical trials, where demand is periodical, and most companies do not have the in-house team to run a study themselves. In this case, a freelance biostatistician could also help the company plan studies, interpret data, design experiments, perform research studies, compile datasheets or write algorithms for clinical trials. The biostatistician could establish sufficient sample sizes and appropriate methods to achieve meaningful data, while saving time and costs by not making them larger than necessary.
Naturally, medical device companies might be hesitant to involve freelancers for confidentiality reasons — sadly, small businesses can be particularly vulnerable to IP theft. A study from the International Society for Manufacturing, Service and Management Engineering (ISMSME) reports that EU start-ups have little to no access to patenting and legal expertise. As well as vulnerability, it adds a financial disadvantage, as these businesses will need to safely share information with potential investors to receive financial backing.
However, if companies are clear about the information they share with freelancers and invest time in confidentiality documentation, such as non-disclosure agreements (NDAs) and contracts, this concern can be addressed. Some online platforms facilitate confidentiality easily, by requiring freelancers to sign NDAs that mean IP is protected whether the company hires the freelancer or not. Kolabtree offers double protection by also assigning all IP rights to clients and enabling custom contracts and NDAs from the organization for added protection. It also provides secure online communication between freelancers and employers to prevent high-risk files from being shared offline or via personal emails, giving clients full control over their project’s privacy and visibility.
The medical device ecosystem is changing fast. By tapping into the growing global network of freelancers, medical device companies can benefit from easy access to talent that is flexible, cost effective and gives them choice, meaning they can create their dream team, while allocating resources effectively.
Ashmita Das is the CEO of scientific talent platform Kolabtree.
According to PwC, the healthcare industry is set to become the largest spending sector on research and development (R&D) globally. Much of this comes from large players, who have both hefty teams in-house for everything from research to regulatory writing, and deep pockets for financing their product launches. The same is cannot always be said for start-ups and small and medium enterprises (SMEs), who must compete in a challenging environment.
However, the success of these smaller medical device businesses is vital. According to Eurostat, 14.3 per cent of all medical technology patents in Europe came from SMEs, and the medical device sector is one of the top five industries in Europe that benefits from the innovation of smaller businesses. To bring products to market and launch successfully, small medical device businesses therefore have difficult decisions to make on how best to allocate resources.
A difficult decision all medical device businesses must make when bringing products to market is how best to build their team. Recruitment can be a tricky thing to manage in an industry where demand is periodical — full-time staff may not always be a feasible option. Looking at jobs posted on Glassdoor, the average medical device consultant salary is around $60,000 per year.
The Rise of Outsourcing
Outsourcing offers medical device companies a host of benefits — cost savings, faster time to market and reduced workloads, as well as reducing the financial risk, likelihood of recall and potential for harm to patients. One important benefit of outsourcing is that it enables access to highly-specialized skills, while avoiding the need to hire permanent staff to cover periodic demand — teams can be brought together as and when needed, offering increased flexibility. One of the most popular areas to outsource, for example, is data management, statistical analysis and data analysis, which is typically tied to clinical trial data and varies depending on the stage in the project.Outsourcing can also help medical device organizations to be better equipped to face regulatory changes, such as the recent update to the EU Medical Device Regulations (MDR). As global regulations tighten, the new framework increases the demand for clinical evidence, reporting and clinical trial management. Consequently, medical device companies are outsourcing bigger chunks of their research and regulatory work to specialists.
To meet the needs of medical device manufacturing businesses, the contract research organization (CRO) pool stands strong. Medical device companies can outsource almost all parts of the process to CROs, from design, to manufacture, to packaging, to testing.
However, contracting a CRO doesn’t necessarily bridge all of a medical device company’s skills gap. There are different types of CRO available, varying in specialism. Many of them also do not have all the required skills in-house, especially for highly specialized projects. This means that CROs often consult third-party specialists or scientific freelancers to bolster the services they offer clients.
In this instance, medical device companies may be paying a premium to access skills through a CRO middleman that they could have targeted directly — an external consultant can cost up to $20,000 a week. It is always worth researching CROs in detail, as well as asking them for their credentials and case history of working in the specific niche, before committing to their services.
Managing a Growing Pool of Specialists
The medical device skills space is a complex ecosystem — to access all the skills required, many medical device organizations work with several external agencies on different projects, including CROs, contract manufacturing organizations (CMOs) and more. According to a 2019 survey by Accenture Life Sciences, one in five manufacturers work with over 100 external partners! This can be challenging to manage, as well as costly for the medical device company.Working with multiple partners introduces several challenges. Firstly, a member of the medical device team, or multiple people, will have to co-ordinate agency and expert management, including service delivery, payments and compliance. Secondly, a wide pool of consultants can introduce intellectual property (IP) and confidentiality challenges, particularly as many small businesses do not have their own in-house patent attorneys.
Create Your Dream Team
One way to remove these pain points is to work with freelancers, contracting specialists for individual tasks, such as grant applications, regulatory documentation, clinical trial design or statistical analysis, for a defined project length. Depending on your requirements you may want to consider working with independent consultants, rather than hiring a CRO. This is a particularly suitable option for businesses that need help with a very specific aspect of their research, like desk research for a market survey or literature search, or manufacturer shortlisting.A freelance medical device consultant can be a real benefit to SMEs and start-ups, offering highly specialized expertise quickly, even within 24 hours, without the medical device company committing to a long-term hire or partnership. On many platforms, the freelancer quotes upfront and the medical device company only pays for the work completed, with no extra retainer fees or minimum order values. This model provides access to high-quality talent, but in a more effective way than working with agencies — data from Kolabtree shows that hiring a freelance consultant can save up to 40 per cent.
Working with freelancers means manufacturers can access heavy regulatory support, as and when needed to achieve device certification or maintain annual documentation. For example, a manufacturer seeking to market their product in the EU could hire an experienced freelance clinical evaluation report (CER) writer, with prior experience of the legislation.
The same can be true of clinical trials, where demand is periodical, and most companies do not have the in-house team to run a study themselves. In this case, a freelance biostatistician could also help the company plan studies, interpret data, design experiments, perform research studies, compile datasheets or write algorithms for clinical trials. The biostatistician could establish sufficient sample sizes and appropriate methods to achieve meaningful data, while saving time and costs by not making them larger than necessary.
Naturally, medical device companies might be hesitant to involve freelancers for confidentiality reasons — sadly, small businesses can be particularly vulnerable to IP theft. A study from the International Society for Manufacturing, Service and Management Engineering (ISMSME) reports that EU start-ups have little to no access to patenting and legal expertise. As well as vulnerability, it adds a financial disadvantage, as these businesses will need to safely share information with potential investors to receive financial backing.
However, if companies are clear about the information they share with freelancers and invest time in confidentiality documentation, such as non-disclosure agreements (NDAs) and contracts, this concern can be addressed. Some online platforms facilitate confidentiality easily, by requiring freelancers to sign NDAs that mean IP is protected whether the company hires the freelancer or not. Kolabtree offers double protection by also assigning all IP rights to clients and enabling custom contracts and NDAs from the organization for added protection. It also provides secure online communication between freelancers and employers to prevent high-risk files from being shared offline or via personal emails, giving clients full control over their project’s privacy and visibility.
The medical device ecosystem is changing fast. By tapping into the growing global network of freelancers, medical device companies can benefit from easy access to talent that is flexible, cost effective and gives them choice, meaning they can create their dream team, while allocating resources effectively.
Ashmita Das is the CEO of scientific talent platform Kolabtree.