Table of contents:
Developing and manufacturing medical devices that are fit to use in frontline healthcare is a complex venture. Converting groundbreaking and life-altering device concepts into final products is a journey fraught with inevitable challenges. As a result, medical device developers rely on contract service providers to reduce the risk of device recalls and expedite the time to market.
Medtech Contract Research Organizations (CROs) are organizations that offers research services on a contractual basis to the medical device and in-vitro diagnostic industries. These services encompass various areas such as biologic assay development, commercialization, clinical development, clinical trial management, and the generation of real-world evidence.
In this article, we'll talk about the main problems that CROs face. We'll talk about what's happening in the CRO industry right now and how companies like Outbound Pharma are making it easier for them to find to sell their services.
Industry Trends and Market Dynamics in MedTech field
The global medical device contract research organization (CRO) market size has exhibited significant growth, with a valuation of USD 7.21 billion in 2022 and a projected compound annual growth rate (CAGR) of 8.8% from 2023 to 2030 This expansion can be attributed to several key factors:
the surge in medical device-specific clinical trials has driven the demand for CRO services
the increasing preference for advanced medical devices
medical device companies are actively seeking ways to reduce research-associated costs, making CROs invaluable partners in navigating complex regulatory requirements and compliance challenges.
During the COVID-19 recovery period, the medical device pipeline saw consistent growth, aligning with the escalating demand for innovative technologies and patient-friendly devices.
In today's dynamic medical device industry, a noteworthy trend is the development of small and portable products, requiring sophisticated manufacturing technologies and automation systems. These include life-assistance devices, drug delivery systems, therapeutic devices, and patient monitors. As these devices become smaller, their features and performance continue to improve, with a particular focus on wearable and implantable devices for monitoring, administration, treatment, and patient condition tracking. To remain competitive, medical device companies are keen on enhancing their products, which will undoubtedly fuel the demand for contract research services in the years ahead.
Contract Research Organizations (CROs) Behind Medical Device Success
Have you ever wondered how medical device companies handle the complex tasks of developing products, conducting clinical trials, and meeting strict regulatory requirements?
What Does A Medical Device CRO Do?
CROs are strategically established to help reduce expenses for companies engaged in the development of new medical devices or In-Vitro Diagnostic Devices (IVD). Their primary aim is to streamline the entry process into the MEDTECH market, simplifying the development phase. This approach alleviates the necessity for larger MEDTECH companies to handle all aspects internally, a practice that has become obsolete. Additionally, CROs extend their support to foundations, research institutions, universities, and governmental organizations.
Many CROs provide clinical-study and clinical-trial support for medical devices and IVD. However, the sponsor of the study retains responsibility for the quality of the CRO’s work. CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new device from its conception to FDA/CE or UKCA marketing approval, without the device or IVD sponsor having to maintain a staff for these services.
How CROs can help with your medical device pathway
Preparing a 510(k) or a PMA presents unique difficulties, so it is essential to get advice from professionals who have experience with numerous application types and are familiar with FDA regulations.
In addition to assisting you with the Pre-Submission process, CROs also offer regulatory assessments and regulatory strategies to help you determine the class of your device and its clinical and submission requirements.
Regulatory Assessments - Data is gathered on the relevant medical device to determine the class and pathway that innovative medical device companies should take to market
Regulatory Strategies - Similar to a regulatory assessment, but with more in-depth research and presentation to yield all-inclusive feedback on the testing requirements for your medical device
Employing a CRO during the 510(k) or PMA submission process enables you to audit and assess progress throughout the FDA approval process, quickly gather additional feedback from the FDA when questions or concerns occur, create deliverables to stay on schedule, and set work plans and goals. We are here to support you, so you won't have to take this path alone.
Top Medtech CROs:
In the MedTech industry, the following CROs have consistently delivered excellence, providing the expertise and guidance necessary to overcome the challenges and seize the opportunities in the medical device landscape. Please note that the following list is not comprehensive and it is only meant to illustrate similarities and differences for informational purposes only.
Avania is an integrated global, full-service CRO with specialized expertise in medical device, novel technology, and combination products. They advance products from feasibility all the way through post-approval in analytics, clinical trials, consulting, medical writing, quality management, regulatory, reimbursement, and more.
Why they are different: Focused, full-service development solutions, therapeutic excellence built on 30 years of experience, personalized technical, therapeutic, and clinical training for investigators and study teams, regional teams with global expertise
Medelis is a specialized CRO with a wealth of experience in regulatory strategy, classification, and registration requirements. They excel in clinical program execution and product development, leveraging strong site relationships and deep insights into established processes and systems. Why they are different: Strong focus on clinical program execution, deep insights into established processes and systems, tailored support for start-ups and medium-sized companies
CTI: Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO) that offers a wide range of clinical trial and consulting services spanning the entire development process, from conceptualization to successful commercialization. Their distinctive therapeutic focus provides pharmaceutical, biotechnology, and medical device companies with specialized expertise in a variety of medical fields.
Key differentiators: Global reach with a private and full-service approach, comprehensive services across the development spectrum, specialized expertise in a wide range of medical fields
Eurofins Scientific is an international life sciences company, offering a diverse range of analytical testing services across various industries. For medical device and biomaterial companies, Eurofins Scientific is known for providing the most diverse and comprehensive suite of testing and engineering support available. With laboratories strategically located around the world, Eurofins scientists have been instrumental in supporting customers engaged in the creation of a wide range of medical devices, including ultrasounds, surgical tools, vascular devices, stents, dental and orthopedic implants, catheters, and medical robotics.
What sets them apart: Broad and comprehensive testing and engineering support for medical devices, scientific expertise in challenging analytical measurements and complex materials, commitment to innovation and problem-solving, global reach with strategically located laboratories.
Labcorp is a leading Contract Research Organization with a strong emphasis on preclinical medical device development, offers specialized expertise in microbiology and reusability validation, biocompatibility assessments, efficacy studies, surgical services, and analytical chemistry.
Why they are different: 40 years of experience and a team of 150 dedicated specialists, they conduct approximately 6,500 studies annually, covering a wide spectrum of medical device indications, from orthopedics and cardiovascular to ocular and wound healing.
Parexel: Parexel's global reach, regulatory expertise, comprehensive support, and adaptability make them a standout partner for organizations seeking to navigate the complex landscape of medical device development and regulatory compliance. Why they are different: Global presence with a vast network of over 19,000 international professional, end-to-end support, integrated consulting expertise in blending clinical development capabilities with regulatory guidance, enhancing efficiency and effectiveness in medical device development.
CMIC Holdings Co.: a Contract Research Organization with over 30 years of industry experience, boasts a team of highly skilled researchers. CMIC Holdings Co. offers a range of services centered around Regulatory Affairs Expertise. Their regulatory consultants are well-versed in Medical Device specialties, assisting with product categorization, classification, and registration documentation for various classes of Medical Devices, including Class I, Class II, Class III, and IV devices, as well as clinical trials.
Why they are different: Comprehensive Regulatory Expertise across multiple countries, high-risk product expertise, full-service support, designated Marketing Authorization Holder (dMAH) Services.
NAMSA has been at the forefront of healthcare improvement since 1967, assisting medical device Sponsors. With a commitment to expediting medical device product development, NAMSA leverages its extensive global regulatory expertise and therapeutic knowledge to offer clients efficient and cost-effective progress throughout the development lifecycle. NAMSA's services encompass medical device testing, regulatory and quality consulting, reimbursement expertise, and clinical research support.
Why they are different: Extensive Experience with 50 years of experience, comprehensive services, 1,500 international associates operating in 18 locations worldwide.
ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. They possess in-depth knowledge of regulatory compliance, operational guidelines, and safety protocols. Founded in 1996, ProTrials has been successfully supporting clinical research for over 25 years.
Why they are different: A dedicated team with extensive experience in the medical device sector, over 20 years of successful project delivery in more than 35 indications within medical devices and diagnostics.
Qserve Group serves as a global partner for Medtech Regulatory, Clinical, and Quality Compliance, as well as a CRO for Medical Device Clinical Trials. Their extensive knowledge and experience enable comprehensive support for achieving market access worldwide, catering to a wide range of Medical Devices. Why they are different: Over 25 years of industry expertise, global presence with offices in the Netherlands, US, China, Germany, and the UK, comprehensive support across the entire product lifecycle, specialized experience in diverse medical device categories and indications.
Factors Driving Outsourcing
CROs are challenged, now more than ever, with identifying their customers’ key decision-makers and influencing those individuals based on an understanding of their decision-making processes. Sales and marketing efforts that are off-target, aimed at the wrong people, or utilizing messaging that is disconnected from decision-makers’ pain points, always fail to deliver full value from the resources CROs invest in the effort. Even well-established CROs with years of experience in marketing their brand to prospective customers can be impacted by inefficient messaging.
Outbound Pharma: Partner for MedTech CROs Lead Generation
Finding new clients in the fast-moving healthcare manufacturing field can be challenging and we totally understand how busy things can get. Our experts specialize in lead generation within the healthcare industry and customize approach where we focus on Account-Based Marketing (ABM), reaching out to potential clients, and creating demand for your products. So, if you're in the healthcare equipment and devices sector, we've got just the finely-tuned lead generation campaigns you need!
Outbound Pharma is well-positioned to help medtech CROs identify their customers’ key decision-makers, as well as individuals with early levels of decision-making authority or those whose opinions inform and can sway key decision-makers. We also can help CROs fine-tune their messaging by refining their knowledge of customers’ decision-making processes (i.e., who makes key decisions at different stages of development, and how those decisions are calculated). This information empowers CRO marketing departments to transition from broad, product-based messaging — focused on how good their services are — to messaging focused on how their services address specific customer concerns.
Client Onboarding
It all starts from the basics. Our process begins with helping clients understand the value proposition and the relevant buyers for their services. Two main ideas guide our lead generation campaigns:
The Decision-Making Unit (DMU) — Individuals comprising the group that picks, or has influence over, which service provider will win the bid.
The Decision-Making Process (DMP) — How the DMU arrives at its decision, in terms of how the group circulates information, how much authority group members have, which group member or members have the power to make the final decision, and how motivations differ among different DMU members.
By conducting a needs and behavioral analysis of customer decision making units, our CRO clients are able to identify discrete sets of needs at their customers’ organizations, enabling the client to tailor their communications accordingly. This analysis also reveals to our clients additional segments to target that they may not have previously considered to be part of the decision-making process (e.g., it could be discovered a head of regulatory affairs has more influence on the decision making process than initially believed).
Outbound Pharma tailors content toward the perceived buying segments. Utilizing quantitative data, we provide you with a more complete understanding of individuals involved in the purchasing process. That understanding, in turn, enables our clients to more confidently allocate marketing spend towards those segments based on the percentage of decision-making influence per segment identified in the first phase. We also identify new segments to target — individuals who may not directly involved in the final decision but are crucial in identifying vendors and had influence over the decision-makers.
Consistency in Lead Generation
When you partner with a professional lead generation consultancy, you're setting yourself up for a reliable stream of leads. They handle prospecting and outreach for you, sticking to a regular plan to meet your lead generation targets. This means your in-house sales team will always have a steady supply of high-quality leads that are already pre-screened. Plus, your marketing team gets the benefit of up-to-date contact details and valuable insights about businesses for their online campaigns. This external help can even take care of nurturing leads until your company is ready to dive into more in-depth follow-ups.
Optimized Sales Team Focus
When we talk about outsourcing, we're basically talking about getting some tasks done by experts outside the company so that our in-house sales team can put their energy into the important stuff: they can focus on building relationships and nurturing clients, making proposals that fit just right, and collaborating with leads that are genuinely interested. The attractive thing about outsourcing is that your team doesn't have to split their time between early-stage opportunities and the ones that are ready to make a purchase. It's all about making the most of your efforts!
Outsourcing is like getting extra help without having to hire a bunch of new people and deal with all those costs. You can really expand your sales programs without blowing up your budget. It helps you keep the money flowing in – you get those chances to grow your revenue and seal the deal. Plus, you'll always have a steady flow of potential healthcare leads lined up, which means you won't run out of opportunities to make sales.
Appointment Setting Services: Quality Over Quantity
Let's talk about setting up appointments – it's all about getting the right ones. At Outbound Pharma, we take quality seriously in our appointment setting services. We carefully go through each lead, interact with them, and making sure they're a good fit for you. Our team, made up of experts in the life-science field, knows the ins and outs of this industry. This means you'll only meet with people who can actually make decisions that matter. It's about quality over quantity here.
Our team has been in the business for over 7 years, working closely with B2B life science companies. We're really passionate about coming up with clever ways to assist sales and marketing teams in getting better leads. We know healthcare inside out, so we get what you're up against and where the possibilities lie.
Collaboration and Customization
Our partnership goes beyond just outsourcing; it's a real team effort. We work closely with your team to really understand your value proposition, who you're trying to reach, and what you want to achieve. This helps us create custom strategies to find potential customers that match your company's values and will likely be interested in what you offer, all while making sure we follow the rules.
Conclusion
When it comes to lead generation solutions tailored to the unique needs of MedTech Clinical Research Organizations (CROs), Outbound Pharma stands as your dedicated partner in success. In today's dynamic landscape, where identifying key decision-makers and crafting precise messaging is crucial, our expertise shines through. By partnering with Outbound Pharma, you're not just outsourcing; you're gaining a dedicated team that understands your industry inside out. With our expertise and collaborative spirit, success is not just a possibility – it's a certainty.
Ready to take your next steps? Book a quick call with us today.