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New Year, Fresh Start
A new year has arrived, bringing with it a fresh start after making it through last year’s hectic year-end activities. The beginning of a new year is a good time to reassess where your business is relative to your strategic goals.
Achieving these goals is not always straight forward, even with a stellar business plan.
For assay developers, goal-challenging scenarios can pop up at any time.
Do any of these disruptive scenarios sound familiar?
- Scenario 1: The supplier of a key assay component sent notice that their business will close in six months. Your lab now has less than a year to find a new supplier to avoid your proprietary assay from going on backorder.
- Scenario 2: Your clinical lab finally got its new assay up and running but didn’t expect the high influx of test samples. A good problem, but you lost customers due to slow turn-around times because your assay throughput couldn’t match demand.
- Scenario 3: The launch of your new infectious disease assay was delayed because the regulatory review agency flagged a missing quality control (QC) step. Now, you must amend the quality management system (QMS) to include a new QC.
Even if last year was devoid of troublesome scenarios, what is the possibility that this year will bring the same good fortune? Especially if this is the year you have planned for 10%, 20% or more growth? Are you behind or on track? Could you push your assay commercialization returns further?
Whatever your commercialization plans are aiming to achieve, your goals have a higher probability of success if they are specific and shared with the right partner.
Thermo Fisher’s Genetic Sciences Original Equipment Manufacturing (OEM) and commercial supply Business Development Managers (BDMs) are ready to be the right partners for your molecular assay development. Here are some ways a BDM can help keep your development goals on track.
The first step in partnering is finding the best team to fit your needs. Thermo Fisher’s OEM business includes a variety of experts to help with your assay development goals.
Start by connecting with a BDM who can review a checklist of your biggest priorities and help you navigate Thermo Fisher’s assay development technologies, products, services and support.
For example, do you need to expand your throughput? Do you require higher quality reagents? Are you looking for ways to improve the efficiency of your production process? A BDM removes the guesswork, assisting your business in finding the appropriate custom solution.
In other words, a BDM can be an accountability partner for your business’s success. They will assist you with your commercialization needs, working with you to help things go according to plan.
Many assays have high quality control standards to ensure the accuracy and reliability of a specific test. As described in Scenario 1, a loss of a reagent supplier can have a significant impact on an assay developer’s timeline and marketing strategy.
Handling increased demand is another area where a BDM can be a great partner. As mentioned in Scenario 2, high demand for a new assay is a good problem but only if assay throughput is easy to scale.
A BDM can help an assay developer analyze bottlenecks in an existing assay platform and suggest possible areas where Thermo Fisher automation or new reagents could improve an assay’s workflow.
If an assay is still in development, a BDM can recommend various Thermo Fisher pre-planning services to ensure commercialization resources meet post launch demands.
The quality of molecular assays is increasingly more important because unreliable test results can lead to serious consequences. For this reason, assay developers and regulatory review agencies understand the importance of keeping records of equipment and raw materials, data, operator performance and quality control (QC) results as part of a quality management system (QMS).
Recognizing quality is important but maintaining quality standards takes time and commitment. A BDM can help a business alleviate quality concerns by recommending Thermo Fisher services for assay design and validation or leverage the right Thermo Fisher instruments and reagents already approved for OEM use from our portfolio.
By partnering with you to find a quality solution, a BDM can provide peace of mind, leaving you free to focus on successful business growth.
Resolve to begin a partnership
Your molecular assay development goals are important. Why not increase the success of reaching your goals by bringing in an OEM partner?
This year commit to accelerating your impact on the world by working with a world class partner invested in helping you meet your strategic goals.
Related Links & Resources
- Learn more: Genetic Sciences OEM and Commercial Supply
- Article: Four Things You Should Know About Customized OEM Solutions
- Article: How to Help Ensure Your Supply Chain Security
- Article: Why Secondary Sourcing Should Be Your Primary Plan
- Article: Nine Questions to Ask When Considering an OEM Partner
- Reference: Journal of Applied Psychology
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