What makes top medical device companies successful? The first answer for most would likely be profit, but profit is a product of success, not the key to success. Given the complexity of developing medical devices, the challenges companies face from concept to production to regulatory approval to market are many. Today’s healthcare industry is fluid. Medical device companies cannot simply offer a unique product or technical expertise to ensure sales. It needs to consolidate such offerings into healthcare systems to provide a broad range of solutions that are need-based for all parties—patients, physicians, clinicians, insurers, and other companies.
A Practical, and Proven, Approach
A first step is providing a device that is receptive in many sectors of the industry. One practical approach to success, but is often overlooked, is by fulfilling an unmet need. Stand in the shoes of a practitioner—learn and listen and observe. Whether in the operating room or lab, surgeons, scientists, clinicians, and administrators all look to optimize efficiency that can or will improve procedures and practices to benefit patients. Successful medical device companies that choose the right component part at the right time often are only fulfilling an unmet need—a device whose time has come. They focus on core features and functions, avoid add-ons or additional features that could bring additional costs, more financing, FDA scrutiny and delay to market.
Creating and Maintaining a Budget
Successful medical device companies budget effectively. New companies can avoid cost overruns by budgeting in unanticipated delays up front. You don’t have to think about problems you may encounter when bringing a medical device to market but it’s important to budget for them in advance. The FDA approval process alone is a long one. Regulations are in place to ensure safety. Products must be tested and verified, strict guidelines must be adhered to, and be thoroughly documented. Having to take a step back more than once is part of the process. Budgetary related setbacks can be overcome with effective anticipatory budget management practices.
Those small companies or startups that may have a solid medical device may lack the expertise and experience to successfully bring the device to market. The expertise may be limited to one or more areas, which are helpful, but a daunting hurdle to overcome on the road to success. Companies can build success by considering partnering or contracting with other medical device companies that offer single source provider services.
Top Medical Device Companies, That are Also OEM
A proven model of success are those medical device companies that offer single source provider services to other companies, labs, hospitals, health providers, inventors and the like. These companies are original equipment manufacturers (OEMs) of medical devices. By functioning as a single source provider, they are well-positioned to service a variety of industries focused on producing medical, diagnostic, laboratory, research, biomedical, clinical, and pathology devices.
Such companies can provide a wealth of information and a range of services to bring a medical device to market. The services are done under one roof—consultation, R&D, manufacturing, packaging, and assembly needs—to meet all regulatory requirements for medical device engineering and production. This includes design, drawing, and engineering, and then the necessary tooling, molds, computer modeling, and statistical process control for production.
All facets of production—state-of-the-art injection blow molding, sterilization services, custom packaging, pad printing, DNase/RNase free manufacturing, and process validation services are in place to support the intricacies of the product development cycle. Material components of a device can be developed and tested onsite. In-house engineering teams experienced working with both standard and unique materials, especially for the varying types of synthetic polymers that are widely used in the latest plastic medical components by laboratories worldwide. Single source providers have the resources to work with a range of materials such as polypropylene, polyethylene, acrylic, polycarbonate, and polystyrene. Rigorous quality control standards are in place to meet the stringent requirements necessary to be awarded medical device approval as well as 510K filing specifications.
Understanding and Catering to Demand
Giving the people what they want is an age-old maxim that still rings true as a means to success for businesses. Today’s healthcare industry is no exception. There are many challenges that must be met for medical device companies to succeed. Finding your niche, and building success maybe in fulfilling unmet needs, finding a place for your device, and building long-lasting working relationships within the industry.
