Selecting a contract manufacturer for your medical device is a strategic, long term investment. Every OEM (or Original Equipment Manufacturer) must have a proven approach to selecting a new contract manufacturer. Partnering with a contract manufacturer is in many ways similar to a business merger. Naturally, a partnership implies a great deal of give and take. If the ‘give’ does not match the ‘take’, it wouldn’t be a very pleasant partnership, right?
So, whatever you do, don’t partner with a contract manufacturer in a hurry! Take the time to find the perfect fit for your product. If you can’t find a perfect fit, then and only then should you consider the closest CM to your perfect fit.
With the medtech contract manufacturing sector set to grow at a rate of 11.3% (CAGR 2020-2026), there is no dearth in the number of contract manufacturers out there. However, your choice in partnering with a CM will determine the growth rate and efficiency of your medical device and thus your OEM business as a whole. Factors such as cost savings and outsourcing of low value tasks are no longer the sole drivers when considering a Contract manufacturer. So what should you be focussing on?
Here are the top five facts that an OEM must focus on, when choosing a contract manufacturer:
#1 Contract Manufacturer’s Specialization
Although an implicit requirement, a contract manufacturer’s specialization brings a number of limitations with it. Many CMs try to enter a new market by showcasing capabilities they have that are similar to the general production requirements of medical devices. While it’s great that you have feasible options to choose from, these may not turn out to be the best fit. Simply because, they may not have the necessary expertise or quality systems in place for your specific medical device.
When looking at CMs with closer specializations, there could still be limitations that make work harder for you. Take Endoscopy for example: the requirements for an Arthroscopic procedure differs from that of a Trans-oesophageal cardiac endoscope. The design, materials used and assembly process varies for each device. So, if you want an endoscope and you’re considering a contract manufacturer who has medical device experience, but in the form of catheters or surgical instruments, you may find that a lot of time, training and investment is needed to make sure you get the kind of product you want.
During the course of your search, you will find some manufacturers that have ample capabilities or are diversified in designing and manufacturing of numerous medical devices. In which case, they can be considered as a potential partner. However, don’t stop at this point, there are many other aspects you still need to consider before you narrow your list of potential CMs down to just one or two.
#2 Contract Manufacturer’s Experience
Experience comes from operating in the medical devices field for a long time; it also comes from having qualified and individually experienced resources on hand who have the know-how to deal with medical device design and production. Ideally the contract manufacturer’s experience should help you improve business efficiencies. Efficiencies in terms of better design of your product, better production techniques, or better supply chain efficiency. Today, innovations in product design, are greatly sought after. For example, if the CM has the capability to provide DFM (design for manufacturability), prototyping, DFMEA analysis, etc. the value add to your production will be considerable.
Such capabilities imply that the contract manufacturer has a team of production and design engineers, in-house, ready to evaluate your product design and bring out innovative improvements that can reduce your time-to-market and save on production costs in the long run. You can always ask the CM if his team includes experienced R&D personnel. Take a look at the CM’s track record, how many of the CM’s products are still in the market? What kind of end-user feedback does the product pull in?
Innovations in production processes such as cutting down on redundant steps, reducing the amount of wastes from the production, using more advanced technology such as automation, robotic assembly lines, micro-manufacturing etc. help drive precision manufacturing, reduce overall costs and saves time in the long run.
#3 Service Offerings apart from Manufacturing
Apart from the production process, does the CM provide other services that are part of their offering, which will benefit you? Services such as:
- Product designing expertise – R&D support
- Packaging facility – labelling and packing of products in accordance to OEM’s brand specifications
- Product sterilization and/or the ability to manage outsourced sterilization services (if required)
- Delivery to your clients – an end-to-end supply chain offers a huge value add.
- Regulatory submissions – for marketing approval, post-marketing surveillance and other FDA requirements etc.
- Post-marketing surveillance – including handling of product feedback, recalls, upgrades etc.
- Repairs and servicing of manufactured medical devices – an aspect of post-launch product management. A CM that offers this service is one who is significantly invested in the medical device domain.
Find out whether these features are part of their service offering or do these need to be added on to the CM’s service offering.
#4 Quality Systems
When it comes to medical devices there’s no substitute for quality. Firstly because of healthcare and medicine is a highly regulated field and secondly, because your product’s quality sets your brand apart in the healthcare market. End-users such as physicians, medical technicians and other medical staff will notice good quality when they use your product. You can’t ask for a better brand ambassador that the quality you send out into the market!
To ensure that you get the highest quality, check for FDA Standards, ISO 13485, QMS regulations such as the FDA QSR, FDA 21 CFR Part 820, etc. These standards are accepted in the United States and in most parts of the world. FDA approval of the manufacturing facility is also important to ensure that you gain the final marketing authorization for your product.
If you intend to export your medical device to Europe ensure that the newly updated (2021) medical device regulations in the form of the EU MDR; and for the UK – post-Brexit, the MHRA guidelines (Medicines and Healthcare Products Regulatory Agency), are being complied with. Some products can receive a CE mark, however, the EU MDR is more comprehensive in comparison.
Contract manufacturers should allow you to audit their facilities (virtually if in person is not feasible), verify their compliance records, verify their quality system reporting including:
- Device history records
- Statistical process monitoring records
- Process validation
- QMS software (some CMs use a dedicated software for this)
- RoHS compliance – is required in California and Europe. There is a Restriction of Hazardous Substances in the manufacture of electrical and electronic products.
#5 Adaptability and Convenience
A Medtech Contract manufacturer that passes your requirements #1-#4, should be good to go. But, if you really want to create a mutually beneficial partnership, you should also look for adaptability and convenience. For example: a CM may be able to handle the production of 200 medical devices for clinical testing. Once approved, they should still be able to produce 20K-50K units. But look a bit further and ask about possibilities to scale up to 100K units or more. The CM’s adaptability in such matters can add tremendous value to your business, since you will not have to look elsewhere to fill surplus or additional orders.
Supply chain efficiency in the form of shorter lead times, improved control over quality and keeping costs comparatively low. Such a supply chain is possible with vertically integrated contract manufacturers. They are able to extend their reach significantly and in turn pass this benefit on to you, i.e. when your customers ask about your reach, your vertically integrated CM will be a value add to you.
Location of the headquarters, the production facility and location of additional production facilities across America and the world. Choosing a CM based in your city is ideal, however that’s not always possible. So look for one that’s relatively close to your customers and to you. Take special care when evaluating a CM with manufacturing facilities based outside of the US, since there are a number of customs regulations to be followed for import. If the facility is located in countries such as China, the trade barriers will necessitate additional steps to gain import approval. In addition there are time zone considerations to be made that will affect the frequency of meetings, follow-ups and other communications.
Your support requirements in terms of training, providing specialized equipment (if needed), scheduled project management meetings, commitment to visit the manufacturer’s facilities, etc. also determines how convenient the partnership will be for you as well as the contract manufacturer.
The Perfect Fit!
So choosing the perfect fit is dependent on both parties. What is the nature of the medical device, and culture of the OEM’s business? Match the contract manufacturer’s specialization, experience, Quality, services offerings, adaptability and convenience to your OEM business. Then weigh the benefits of each manufacturer against each other, rather than considering each CM for its individual benefits. Create your own rating system based on each parameter you want for your unique business, rate and compare the CMs of your choice. And you should be able to decide on the Perfect Fit Contract Manufacturer for your Medical Device.
Instrument Technology Inc. is a veteran owned, five decade ‘young’, vertically integrated, ISO 13485 compliant, FDA approved facility for the manufacture of medical devices. We offer DFM, Prototyping, DFMEA and more to place before you what you have only imagined your product to become. Click here to learn about our Medical Devices Specializations or here to learn more about our capabilities. Want to talk to our experts? Contact us today!
There are no secrets to success. It is the result of preparation, hard work, and learning from failure. Paul Tournier