Scientific professionals understand that an idea for a new medical device launches a complex process of design, development, and prototyping. Medical device companies find that working with an experienced consultancy that specializes in refining ideas into finished
products provides savings in cost and time. Selecting the right consultancy to help turn ideas into finished products that comply with regulatory requirements can make the difference between success and failure. The right partner can provide the bridge across what sometimes seems like a vast chasm between design and commercialization. To help you make this critical decision, we provide these tips for choosing a medical device development partner.
Confirm ISO Certification and Expertise in Design Transfer
Creative inventors and engineers may complain about regulatory processes and requirements, but no new medical device will get anywhere unless the development team can demonstrate and document compliance. It’s not the most thrilling part of the development process, but international standards exist for good reason—to protect everyone involved in the design and development process as well as the end user, and to ensure proper documentation of the development process. The first step in choosing a medical device development company should be confirming ISO certification for quality management in the design and development of products for the medical device industry. The applicable standard is ISO 13485. Reputable development partners will readily supply their certificate confirming they maintain a quality management system that complies with this international standard.
New devices that provide diagnostic, research, and treatment innovation also get nowhere if they prove too costly or complex to manufacture. A development partner should be able to guide the design transfer process from prototype and limited-run manufacturing to fully scaled-up production.
In addition to expertise in quality management and design transfer, a device development partner should be able to plan and guide the process from conception to manufacture. This should address every regulatory requirement that comes with each step of the process, including FDA requirements for documentation that accounts for any changes in design due to design iterations. In turn, the partner should manage the process of updating and reapproving documented design plans.
Experience and Expertise in Materials Selection
Materials engineers continue to accelerate their pace, developing new and more refined products. With every new material that may prove promising for medical device manufacturing comes attendant risk. In fact, a high percentage of product recalls are materials related. Attention to detail and knowledge of factors that can cause adverse reactions or product failures are key considerations in selecting a design partner.
Additionally, a medical device development partner should have expertise in sourcing appropriate materials. It’s one thing to know that new materials exist, but knowing how to obtain materials in sufficient quantities at a reasonable cost is another matter.
Ability to Qualify Manufacturers
The best design transfer process can fail if the manufacturer on the receiving end of the transfer hasn’t been properly vetted. A design and development partner for a new medical device should have experience qualifying manufacturers and the ability to participate in or monitor quality in validation and scale-up for manufacturing.
Development of a new medical device requires design and development expertise from a wide array of disciplines. In addition to experts in mechanical, materials, electrical, and computer software and systems engineering, a cross-functional team for device development should include your own experts in operations, marketing, statistics, and compliance. All members of a cross-disciplinary team must have input at each important stage of the design and development process. The multiple perspectives of a comprehensive, cross-functional team can preempt and correct design flaws and add information to the process that won’t come forward if everyone is working in their own silos. Competitive analysis, the willingness of medical and research professionals to test and adopt new devices, and the ever-evolving regulatory environment are factors that must come in to the process at each stage.
A partner in design and development for medical devices should be able to assist in design verification. Essentially, this means that the partner should help confirm that the proposed device is the right device to meet the identified need, and that the device will do what it is supposed to do for whoever is predicted to use the device. The development partner should be able to help verify that the production process results in a product that matches the design specifications. If what comes out doesn’t match what goes in, there will be a preventable problem with the device and the manufacturing process. The right device development partner should be able to ensure that problem won’t happen.
Prototyping involves expensive equipment for fabrication. The development partner should be able to create functional prototypes. This “additive” manufacturing process, which produces parts by building up materials according to computerized directions, permits mid-development alterations to designs. A development partner should be ready and willing to employ the latest improvements in prototype production with sophisticated computerized equipment and processes. New processes like 3D printing can speed the prototyping process.
Devices keep getting smaller and more sophisticated, incorporating self-reporting and diagnostic electronics. For some devices, parts, materials, and processes must be compatible and verifiable at the molecular level.
When selecting a medical device development partner, compatibility and comfort with the company and its personnel are critical. Take note of the quality of communication in the selection process. A prospective partner worth further investigation will be responsive, transparent, and helpful. They will ensure confidentiality of proprietary information and compliance with regulatory processes. Difficulty obtaining necessary information to assist in selection is a red flag. Hesitancy from references or obfuscation in supplying references in the first place are also warning signs that the relationship may not be a successful one.
A great deal of time, money, and labor is involved in medical device development and production. Diligence in selecting a medical device development partner will provide the best chance of successful prototyping, testing, and roll-out of new medical devices.