[DEVICEMED Magazine] Battery: an essential component of stand-alone medical devices

[DEVICEMED Magazine] Battery: an essential component of stand-alone medical devices

Interview with Stéphane JAUD, VLAD Industrial Director by Patrick Renard

Page 22/23 - DeviceMed Magazine May/June 2021

Battery: an essential component of stand-alone medical devices

Certified ISO 13485, ISO 14001 and ISO 9001, the sme Vlad turret is a reference in France for custom medical batteries.
We interviewed Stéphane Jaud, its industrial director, to learn more about this critical element in autonomous medical devices.
Vlad designs its own protection circuits and battery management systems.

Can you introduce us to Vlad and explain the place that the medical profession occupies in its activity?

Since 1985, Vlad has been an essential reference for autonomous energy in the medical and industrial world. We employ more than 70 employees and produce premium battery packs in France with 4.0 equipment. We have a design office dedicated to designing custom batteries for our customers' applications.

The rigour of our processes and the quality of our batteries make us the only player in the market to benefit from a triple certification: ISO 9001:2015 for quality, ISO 14001:2015 for the environment and especially ISO 13485:2016, specific to medical devices.

We impose a high level of quality requirement on our batteries that can be integrated into life-saving devices. In 2020, we participated in the national consortium with Air Liquide to produce the batteries of 10,000 respirators as part of the fight against the Covid-19.

75% of Vlad's business is dedicated to the medical sector, in France and internationally. We sell our batteries in more than 80 countries on all continents. Regarding the design
bespoke, we mainly accompany manufacturers of Class I, IIa and IIb DMs based in France and neighbouring countries.

How does the process of developing your custom batteries work?

Our whole process is done by taking into account the "Battery - DM" system. A battery alone will not do the customer any favours.

Our study and development process is broken down into 7 phases. The ultimate goal is to produce a high-quality industrialised battery that must meet the application's needs from a technical point of view, price and time. We have surrounded ourselves with experts in their field: electronics, mechanics, thermodynamics and industrialization. And in order to remain competitive in terms of costs and respond to the increase in manufactured volumes, we started from 2019, the design and realization of robotic lines "Made In Vlad".

During the first exchanges, if we find that the client is not able to give us a comprehensive specifications, we accompany him to express his need through a study form. It is up to us to remain convincing and pragmatic to draw the attention of our interlocutor on specific points because it is a "living" component that will have to be taken care of to optimize its lifespan.

We will focus on:

  • Volumes to be produced, targeted countries and operating life,
  • The schedule,
  • mechanical dimensions, the level of protection from dust and water, the attachment and connection to the product, the finishing of the outer envelope,
  • Land operating profiles in charge, landfill and storage,
  • operating ranges in tension, temperature and humidity,
  • Associated smart functions,
  • regulatory data (applicable standards and standards, DM class, marking),
  • The requirements in terms of sustainable design,
  • Lifecycle,
  • Packaging,
  • expected deliverables,
  • robotic industrialization in series.

A risk analysis takes place at each stage in terms of product design, production and process.
Each design feeds a collection of feedback through an AMDEC (Analysis of Failure Modes, Their Effects and Their Criticism). We need to ensure the integrity of the product throughout the production chain until the final delivery.

What are the options in terms of technologies, cell format, security, etc.?

We accompany the customer to choose the technology best suited to the use of his product.
There are pros and cons to all technology. We strive to remain pedagogues towards our interlocutor in order to arrive at the best choice of electrochemistry and select the most appropriate format. For cell supply, we work with long-standing partners such as Manufacturers Panasonic, LG, Samsung or Saft.

We cover the main rechargeable technologies (NiMh, Li-Ion, Lithium Fer Phosphate, Lead, NiCd) and primary (Alcaline, Lithium Manganese, Thionyle Lithium Chloride). We remain attentive to new technologies still in the laboratory stage.

Vlad designs its own BMS (battery management system) or PCM (protection circuit) platforms that can be configured in terms of safety (current, voltage and temperature), human-machine interface (charge state, dry contact, LCD), communication (SMBus, One-Wire, I2C), IoT connectivity and robustness (CEM, reinforced connector, isolation) to meet the requirements of the cell and the medical device.

How are regulatory and probate issues addressed?

We ensure a permanent regulatory watch in view of the evolution of standards, decrees, directives, decrees, amendments and regulations.
At Vlad, supported by specialized agencies, we assist our clients in regulations and approvals that mainly cover:

  • design (electromagnetic compatibility, permitted substances),
  • the safety of people and equipment based on technology,
  • Waste management,
  • Transportation.

It remains essential to know the targeted marketing areas as we meet specific requirements in some countries such as UL 2054 standard in the US or PES in Japan, to name but a few examples. We work with approved official laboratories to carry out the tests associated with IEC 60601-1-2, UN38.3, IEC 62133-2, UL2054 and IEC 60086-4.
We have people trained in the regulations "ADR, IATA, IMDG" transporting batteries to France and internationally. The choice of suitable packaging will be mandatory.

Can you give us some examples of achievement?

We are very involved in the design of batteries for respirators, oxymeters, cardiac defibrillators and many medical innovations. I would need several pages of your magazine to give you a complete list.

What advice would you give to manufacturers whose next device needs to be powered by stand-alone energy?

« The sooner we are involved in the genesis of your project, the better we will be able to design together an industrialisable battery that meets your needs. The exchange between our teams must take place at key stages to ensure the success of the project. Electrical and mechanical controls are essential at all stages, from component input control to battery delivery. Be sure to identify the countries where your DM is going to be marketed because from the moment of conception, we will have to take into account specific requirements. You can count on Vlad's teams to guide you ».

Stéphane JAUD Directeur Industriel VLAD

Stephane JAUD

Industrial Director VLAD

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