Three Things to Consider When Choosing Your IVD Product Development Partner
In vitro diagnostics (IVDs) play a critical role in healthcare. Without the specific and accurate diagnostic results that IVDs can provide, medical mistakes and even patient harm can occur. Successful IVDs can significantly impact peoples’ health, while maximizing clinical outcomes, minimizing cost, and reducing both patient inconvenience and administrative burdens. For researchers, it’s exciting to find ways to improve IVDs by:
- Enhancing assay sensitivity or specificity
- Developing a test that’s easier to perform
- Upgrading to a more accessible specimen type or collection method that’s often less painful for patients
IVD development, however, is a complicated and intricate process. It requires a cross-sectional team with expertise in diverse areas such as molecular biology, microfluidics, materials, engineering, usability, manufacturing, regulatory affairs, clinical research, and industrial design. All these people work together to ensure that the product’s components provide consistent and reliable performance over its life cycle.
There’s no question that working with an experienced IVD development partner can make the process easier and more effective for you. But how do you find the right organization to minimize your company’s pain, expense, and inconvenience, all while getting your product to market as quickly as possible?
Here are three key things to consider when choosing an IVD development partner.
Does the IVD development partner have the right expertise?
You may be the world’s foremost expert in a specific analyte-reagent pair. Maybe you’ve created a super-sensitive detection sensor, or perhaps you’ve unlocked unique insights through a new approach to RNA sequencing. These are all impressive achievements in specialized fields. In a similar way, it takes specialized experience and technology to successfully bring today’s diagnostic products to market.
The interplay between product performance and the different aspects of your technology is not straightforward. One change can potentially create a negative ripple effect in your product. That’s why it’s important for your potential IVD development partner to have the right expertise. A successful product development partner has a team of scientists, engineers, and product development specialists who have worked to gain and maintain a deep technical understanding of the relevant science and design processes to ensure your product’s success.
As you choose a partner to bring your product to life, ask:
- Do they ask relevant technical questions and challenge assumptions while remaining open minded and flexible?
- Do they identify the high-risk challenges that could impact product performance and success while providing actionable solutions?
- Do they have the right range of in-house and in-network experience to support development including engineering, usability, molecular biology, regulation, and manufacturing knowledge?
The bedrock of a diagnostic platform consists of molecular biology, clinical chemistry, and sensor technology. The IVD development company you choose to work with should have this foundation and the right expertise for the job.
Know about our expertise in IVD consumable development
Does the IVD development partner have the right expertise?
You may be the world’s foremost expert in a specific analyte-reagent pair. Maybe you’ve created a super-sensitive detection sensor, or perhaps you’ve unlocked unique insights through a new approach to RNA sequencing. These are all impressive achievements in specialized fields. In a similar way, it takes specialized experience and technology to successfully bring today’s diagnostic products to market.
The interplay between product performance and the different aspects of your technology is not straightforward. One change can potentially create a negative ripple effect in your product. That’s why it’s important for your potential IVD development partner to have the right expertise. A successful product development partner has a team of scientists, engineers, and product development specialists who have worked to gain and maintain a deep technical understanding of the relevant science and design processes to ensure your product’s success.
Such a collection of enabling technology, machinery, and facilities might include:
- CNC machining
- Injection-molding
- Laser welding
- Clean room
- Biosafety level 2 lab
- Engineering lab
- Variety of low-volume assembly equipment
Your specific IVD product may require additional specialized capabilities. This may mean you need an IVD development partner with engineers skilled in microfluidics, advanced plastics, molding technologies, and chemistry. It may also be important to be fluent in breadboarding to evaluate electronic circuits, as well as assembly equipment design and development.
Ensuring your product development partner has these capabilities under the same roof will allow your company to achieve its desired outcome while minimizing expenses.
Does the IVD development partner have the right approach?
The processes inherent to product development, validation, and commercialization are complex, interdependent, and multidisciplinary. You want to choose a partner with the right approach to tackle the multifaceted obstacles that come with bringing innovative products to market.
Ideally, your product development partner should employ strategies that emphasize collaboration with you and your team. This maximizes both cost and schedule efficiency, creates a more enjoyable experience, and lowers the stress of interactions while everyone learns from each other.
Since no company is an expert in all things, choosing a partner with a large collaborative network of vetted associates and suppliers who are experts in instrumentation, production and process development, product commercialization, as well as regulatory concerns is critical.
Another key component in your development partner’s approach should include a risk-reduction strategy for product development that leverages proven technologies to reduce the cost and time-to-market. The development partner should start by understanding your objectives, progress to date, concerns, and current product plan in detail. Your team should be engaged in analysis and evaluation of potential development paths and encouraged to think creatively about possible alternatives.
Ultimately, it’s important to select a product development partner who is capable of sparking your own innovations, has complementary skills, and knows the people you’ll need for advisers. This will maximize your efficiency and your likelihood of producing a successful product.
Making the Right Choice
You and your team have devoted time, energy, and talent to solving an unmet need for diagnostic customers. As you create current and future solutions that improve performance, increase convenience and reduce literal and figurative pain, look for a partner who will do the same for you.
Not every product development partner is created equal. There are varying degrees of experience and capabilities in specific areas of expertise, as well as a variety of different approaches and workflows that may or may not blend well with your internal processes. Choosing the right partner for you is a decision that must be made carefully and wisely—after all, you wouldn’t trust your project to just anyone!
